How effective is kinetic chain exercises as compare to targeted shoulder exercises in

the management of overhead athletes shoulder pain: A feasibility study

Summary (in lay language 300 words maximum

Shoulder pain is a common musculoskeletal complaint in overhead athletes. Exercise

therapy targeted at shoulder joint for overhead athletes with shoulder pain or injuries has
been shown to improve shoulder pain and function. However, specialist physiotherapists
advise integrating kinetic chain exercises (based on an idea that these joints and segments
have an effect on one another during movement) in the shoulder rehabilitation program.
There is currently a lack of research-based evidence and evidence-based clinical guidelines
to support or refute the integration of kinetic chain exercises in overhead athletes with
shoulder pain. The purpose of this study is to test whether overhead athletes with shoulder
pain do better with either home-based integrated kinetic chain exercises or targeted shoulder
exercises in improving their pain and function. The information we learn from this research
will help us in developing an evidence-based home exercise program for the rehabilitation of
overhead head athletes with shoulder pain, improving pain and function. The findings may
be useful to apply to other cohorts with shoulder pain. The research findings will also help in
developing future research projects.

Introduction

Shoulder pain is a common musculoskeletal complaint and a significant cost to the health
economy, with a significant impact on healthcare services. The average spend per patient in
the National Health Service (NHS) in the United Kingdom (UK) is £461.13 per head per year
(CSP 2012), with geographic variability 14. The estimated cost to the UK economy is 7.4
billion per year. Currently, there is no recommended National Institute for Health and Care
Excellence (NICE) clinical guidelines, and the care offered can be highly variable.

Our proposed research will provide evidence of the clinical effectiveness of two home-based
exercise interventions routinely used in NHS. The trial team, after careful consideration,
judged that more instant comparisons were needed to address this in order to support our
athletes in rehabilitation and self-empowerment. Self-empowerment can not only help them
to integrate the prescribed rehabilitation program into their training, but also help in
educating them to develop preventative strategies and avoid unnecessary use of healthcare
resources where possible. From NHS Reference Costs in 2010 the average cost for out-
patient physiotherapy was £36; therefore, 12 sessions could cost £480. The cost of clinic-
based physiotherapy sessions could be easily minimised or saved with home exercise
rehabilitation programs in an athletic population who are motivated to return to sports/work
with optimum performance.

We plan to collect patient-centred outcomes of treatment, which will include shoulder pain
and function, quality of life, adverse events, cost-effectiveness and time to recovery. Health
care resource use will be collected prospectively from clinic forms, and using patient
completed questionnaires at baseline, 3, 6 and 12 months. The findings will help inform
current clinical practice.

Evidence about athletes’ shoulder pain experience is limited. Hence we will interview up to 6
participants to understand overhead athletes’ experience on acceptability and satisfaction of
the treatment protocol at 3 months after completion of their treatment. These participants

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will also be invited to comment on what outcomes are important to them, which should help
to facilitate interpretation of the results of the trial. Barriers and facilitators of intervention will
be discussed. At the end of the study, up to 6 health care professionals will be interviewed
about the acceptability of treatments. Data will be analysed using a comparison method
through thematic coding.

Background and Rationale

In recreational and competitive overhead athletes, shoulder pain is very common due to
repetitive strain. The majority of them are seen in musculoskeletal settings (Physiotherapy,
Orthopaedic, Sports clinics). Prevalence of shoulder injury in overhead athletes is reported
to be up to 42% 1, 16, 38, 49, 52, 55. However, other studies have suggested that prevalence is
much higher and is underestimated as many injuries go unreported, especially in youth 49.
The majority of these injuries are presented as non-specific and are put down to repetitive
strain injury. The treatment for overhead shoulder injury is sought much later, at a chronic
stage, which can lead to decreased performance, decreased function or discontinuation of
sports activity 1, 16. The shoulder pain can be excruciating and debilitating; participants may
struggle with necessary daily activities and be worn down by sleep disturbance. As a result,
an adequate early intervention is needed to maintain and optimise performance, improve
pain and function.

Although different underlying mechanism could be related to shoulder pain 20, exercise
therapy should always be first choice of management option. Exercise therapy should
always be included in the rehabilitation to improve pain and function 13, 23, 31, 35, 40-45, 64.
Prescribed exercises are targeted mainly on the most common impairments related to the
shoulder girdle, such as muscle strength or motor control deficiencies. We do not know if
targeted shoulder rehabilitation exercises are sufficient to achieve the optimum improvement
in pain and function or if integration of kinetic chain exercises will provide a superior
outcome. The effectiveness of these exercises needs to be explored before they are
implemented in evidence-based practice.

A recent systematic review concluded that the most robust available evidence supports the
use of single-plane, open-chain shoulder elevation exercises below 90°47. Although these
exercises might be useful for initial rehabilitation, these do not comply with the functional,
sport-specific demands of the athlete to perform overhead. Moreover, this isolated shoulder
approach does not reflect the complexity of overhead activities, including throwing, in which
there is involvement from all kinetic chain segments such as the trunk and lower limbs 36, 37,
70
. Consequently, clinical experts advise incorporating more advanced exercises in
rehabilitation, such as kinetic chain exercises 71. There is promising evidence from small,
short-term trials that physiotherapist-prescribed exercises are useful. We aim to recruit 30
overhead athletes with shoulder pain from musculoskeletal outpatient clinics.

Moreover, the efficacy of exercise therapy, with or without kinetic chain implementation, has
never been investigated. Nevertheless, research-based evidence to support or refute the
application of kinetic chain exercises for overhead athletes is currently lacking. Therefore,
the purpose of this study is:

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Aim

1. Is home based integrated kinetic chain exercises are superior to targeted shoulder
exercises in improving shoulder pain and function in overhead athletes. Kinetic chain
implementation will be achieved by adding lower limb and trunk exercises into shoulder
exercises.

2. To qualitatively explore the acceptability of the different treatments to patients and health
care professionals.

3. To provide valuable patient-centred insight to guide clinical decision-making further.

Overhead athletes with shoulder pain will be invited to the routine musculoskeletal
outpatient's clinics through a promotional flyer for the study. The study flyer will be
disseminated to professional networks, GP clinics, orthopaedic clinics, regional universities,
health and sports centres.

1. Musculoskeletal Services, Kent Community Health NHS Foundation Trust

2. Musculoskeletal services, Maidstone and Tunbridge Wells NHS Trust

Research Plan

Trial Design

A pragmatic, multi-centre, randomised controlled trial (RCT) with a 1:1 ratio of integrated
kinetic chain exercises versus targeted shoulder exercises for the treatment of overhead
athletes with shoulder pain. There will also be a nested qualitative study to explore the
advantages and drawbacks of therapy from the participants’ and healthcare professionals’
point of view. For details on the RCT see appendix 1.

Setting

We will recruit 30 participants from the identified centres to get a diverse and inclusive
population sample. The recognised centres are Kent Community Health NHS Foundation
Trust, Maidstone and Tunbridge Wells NHS Trust. Participants will be recruited from
musculoskeletal clinics.

Musculoskeletal services treat people with a range of musculoskeletal conditions. They

provide a screening, assessment, and treatment service and are usually run by specialist
practitioners including physiotherapists, extended scope physiotherapists, GPs with a
special interest in musculoskeletal conditions, clinical nurse specialists and, in some
instances, rheumatologists and orthopaedic consultants. Overhead athletes referred to the
service are assessed by the practitioner most appropriate to deal with their condition.

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Randomisation

The assessing clinician will identify patients who have been referred to an outpatient
musculoskeletal clinic for shoulder pain. In the clinic, the clinician will confirm the eligibility
and invite the patient to consider joining the study. The clinician will provide an information
sheet and answer any questions. The clinician will ask the patient whether they agree to
consent at that time.

Upon completion of the consent process and baseline forms, the recruiting clinician will
randomise the patient via phone or via the internet, to access a secure randomisation
service and access independent and concealed equal random allocation (1:1), to allow for
the potential difference in effect between treatment comparisons. The patients will be
allocated to one of the following interventions:

1. Integrated Kinetic chain Exercises (IKE) for 12 weeks (experimental)

2. Targeted Shoulder Exercises (SE) for 12 weeks ('control')

To reduce the risk of the randomisation sequence being predictable, we will not stratify by
centre, which, in addition to using randomly selected permuted blocks, will make the
allocation sequence unpredictable for individual trial sites. The randomisation service will
record information and check patient eligibility to avoid inappropriate entry of patients into
the trial. Patients will be informed of their allocations at the time, as well as the clinician
managing each patient. The study office in the participating organisations will send an
allocation letter to the patient explaining what will happen next. The involved clinician and
the participant’s General Practitioner will receive information about treatment allocation. As
the trial is pragmatic in design, comparing two conservative exercise treatment options, the
blinding of participants and clinicians to treatment allocation is not possible or desirable.

Nested qualitative study

Existing evidence about patient experience of overhead athletes’ shoulder pain is limited,
and an exploration of patient treatment preference is broadly lacking. Therefore the clinical
research being proposed will be supplemented by a qualitative investigation of patient
experiences of both the interventions, providing valuable patient-centred insight to guide
clinical decision-making further.

The nested qualitative study will focus on the following objectives to complement the trial
objectives:

1. To explore the experience and acceptability of the treatments to patients and healthcare
professionals.

2. To provide crucial patient-centred insight to guide clinical decision-making further.

We would also like to use this opportunity to explore, as a subsidiary aim, participants’
experiences of taking part in a trial. Although this aim is not closely aligned to the overall trial
aims, it will help to inform the design and conduct of future clinical trials, thus contributing to
the value of this qualitative study for future research. It is also possible that participants’
experience of taking part in a trial is related to the acceptability and outcome of treatments.

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Up to 6 of the trial participants will be recruited to take part in this aspect of the research.
Participants will be drawn equally from those who have experienced each of the
interventions. Those who consent to participate in the trial will be interviewed at
approximately 3 months after their completion of the treatment. This will allow time for
recovery and for participants to reflect on their experience, expectations and outcomes from
the intervention received. Interviews will be semi-structured, with open questions used to
guide a discussion of a patient’s experience of treatment, their opinions about treatment
benefits and drawbacks, their reflections upon shoulder pain and recovery, and their
attitudes towards the home exercise programme and participating in clinical research. A
flexible interview schedule will be developed following a literature review, discussions with
the research teams, participants and clinicians with expertise in this area. Interviews will be
open and flexible, to allow participants the opportunity to introduce new topics and generate
a detailed, personal perspective on the subject 15.

Interviews will be ideally undertaken face-to-face although, given the geographic spread of
participants, it may be more practical to perform some interviews by telephone or through
video interviews on-line (e.g. Skype or face time); it is expected that up to 50% of interviews
will be completed in this way. Interviews will be conducted by the researcher and audio-
recorded with permission; recordings will be transcribed in full, and data handled using the
NVivo computer package.

We will also interview up to 6 healthcare professionals at the end of the trial about their
experience of delivering the treatment. An interview schedule will be developed to address
areas such as clinical decision-making, treatment preference, barriers and facilitators of a
positive outcome of treatments.

To reflect the exploratory nature of this study, and to ensure that the participants’
perspective is at the heart of any insight generated, data analysis will be undertaken
inductively following the conventions of Grounded Theory 15,29, 61,62. This is considered more
fully the Qualitative Analysis section.

Eligibility Criteria

Inclusion Criteria

1. Aged between 18 and 50 years.

2. We’re performing overhead sports for at least 3 hours per week.
3. Experienced shoulder pain in the overhead activities that interfered with sports
participation for at least three months.

Exclusion Criteria

1. Known systemic disease.

2. History of shoulder dislocation or surgery.
3. Non-shoulder related orthopaedic surgery in the last two years.
4. Steroid injection in the previous 3 months in the affected shoulder joint.
5. Pain medication or no- shoulder related complaints within 24 hours before tests.
6. Pregnancy.

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Interventions

There is promising evidence from small, short-term trials that physiotherapist prescribed
exercises are practical. Wright et al. (2017) reported that a single plane, open chain exercise
below 90 degrees has the most robust evidence 71. However, these isolated shoulder
approaches do not reflect the complexity of an overhead athlete throw-in which involvement
is required from all kinetic chain segments such as trunk and lower limbs 36,37, 70. Moreover,
the efficacy of exercise therapy, with or without kinetic chain implementation, has never been
investigated.

Informed consent will be gained. Based on the inclusion and exclusion criteria, participants
will be randomly allocated to one of the two home exercise therapy treatment groups. All
exercises will be thoroughly taught by the trained physiotherapist during the first session
(Week 0). During the session, exercise load will be individually determined by 15 (concentric
exercises) or 15 (eccentric exercises) Repetition Maximum testing 19, 23, 42.. Shoulder pain will
be allowed during training but should not exceed 5 out of 10 on a Visual Analogue Scale and
should have subsided the following morning 23, 42, 60, 67. Additionally, exercise order may be
randomly altered in each session.

Group 1 will perform integrated kinetic chain exercises (IKE) for twelve weeks (Appendix 2).
Group 2 will perform shoulder exercises (SE) consisting of external rotation and scapular
strengthening exercises for twelve weeks (Appendix 3).

Participants will be given one session of advice post-randomisation. This will be a clinical
consultation, including the provision of an information leaflet containing education, advice on
pain management, function and instruction on a graduated home exercise program
progression, a booklet and an optional video demonstration.

Integrated Kinetic chain Exercises (IKE - Experimental treatment)

Participants will be given one session of best practice advice post-randomisation. This will
be a clinical consultation, including the provision of an information leaflet containing
education, advice on pain management, function and instruction on a graduated home
exercise program progression, a booklet and an optional video demonstration.

The IKE Group (Appendix 2) will receive four targeted shoulder exercises. The group will
start the home exercise program after their first assessment and best practice advice by the
physiotherapist. The study information leaflet is developed in collaboration with members of
the public and patients, members of British Elbow and Shoulder Society (BESS), and the
European Society for Shoulder and Elbow Rehabilitation. Each participant will be provided
with the information leaflet, which will explain the study and study protocols. Informed
consent will be gained before enrolling into the study. The intervention group will receive
IKE. Participants will be asked to provide feedback and comment on any aspect of the
program. The exercise program will be videotaped. The information sheet clearly states that
the exercise sessions will be recorded and the reasons why. This information will be further
outlined during the consent process.

The treatment program will be provided in a booklet, in which all the exercises are presented
per week, accompanied by a photograph with a detailed prescription of exercise execution.
Patients will be also instructed to keep a daily logbook to monitor exercise load and

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progression. Participants will be instructed to aim for 15 repetitions of 3 sets of all exercises,
minimum three times per week for up to 12 weeks. They will be allowed to take a one-minute
break in between each set of exercises. All patients will receive training supplies consisting
of a weighted water bottle (0.5, 1, 1.5 and 2 litres) to perform the home exercises.

Targeted Shoulder Exercises (SE)

The SE Group (Appendix 3) will receive four targeted shoulder exercises. SE will start the
home exercise program after their first assessment and best practice advice session from
the physiotherapist. The study information leaflet is developed in collaboration with members
of the public and patients, members of British Elbow and Shoulder Society (BESS), and the
European Society for Shoulder and Elbow Rehabilitation. Each participant will be provided
with the information leaflet, which will explain the study and study protocols. Informed
consent will be gained before enrolling into the study. The control group will receive
Shoulder Exercises (SE). Participants will be asked to provide feedback and comment on
any aspect of the program. This information will be further outlined during the consent
process.

The treatment program will be provided on a booklet in which all the exercises are presented
per week, accompanied by a photograph with a detailed prescription of exercise execution.
Patients will be also instructed to keep a daily logbook to monitor exercise load and
progression. Participants in both the groups will be instructed to aim for 15 repetitions of 3
sets of all exercises, minimum three times per week for up to 12 weeks. They will be allowed
to take a one-minute break in between each set of exercises. All patients will receive training
supplies consisting of a weighted water bottle (0.5, 1, 1.5 and 2 litres) to perform the home
exercises in order to progress or regress the load. They will need to practice for six weeks,
four times per week. Training days will be based on the patients' preferences.

Therapist's role

 Initial session or two sessions.

 Assess the patient.
 Advise on pain management and self-care of shoulder.
 Teach exercises and advise on progression and regression.
 Introduce exercise planner and diary.
 Facilitate goal setting, planning and explore barriers.

Patient role

 Exercise independently with confidence

 Be competent in the progression and regression of exercises
 Overcome challenges and barriers of self-management
 In this randomised clinical trial (Appendix 1), baseline measurements will be
performed before treatment (Week 0). Afterwards, participants will be randomly
allocated into two treatment groups.

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Sample Size

The primary outcome is the SPADI. Secondary outcome measures are WOSI, GIRD and
EQ-5D-5L It will be assessed for the treatment comparison IKE to SE. We will aim to recruit
30 participants over 12 months and follow up for another 12 months. To minimise attrition,
we will exclude the rare patient in this population who will lack the mental capacity to comply
with treatment or data collection. Active and systematic follow-up of all randomised
participants is then planned at 3, 6 and 12 months clinic visit. A text message will also be
sent on the day the patient is sent the postal appointment letter. We will also write
newsletters during the trial to keep the participants informed and engaged with the trial,
which can enhance response rates 48.

The sample size recommended for qualitative research is moot 4. We will interview
participants and healthcare professionals to the point of theoretical saturation in short, until
no further useful conceptual categories emerge. Theoretical sampling is used in grounded
theory to seek and collect, ‘pertinent data to elaborate and refine categories in your
emerging theory’ 15. This method of sampling does not aim to represent a particular
population, but is emergent, allowing analysis to move from an initial tentative category
towards a robust theoretical category 4. Although it is not possible to anticipate the exact
number required, our sample is likely to include up to 6 trial participants and health care
professionals. This number is consistent with recommendations of qualitative research
experts 4.

Outcome Measures

All outcome measures will be determined at the baseline before the treatment and after the
three, six and 12 months of the initiation of home exercise programs

Primary outcomes

1. Shoulder Pain and Disability Index (SPADI)

The Shoulder Pain and Disability Index (SPADI) is a valid, reliable and frequently used
questionnaire for shoulder pain patients consisting of 13 items divided into 2 subscales: pain
(5 items) and disability (8 items). Each item was scored on a 10-point numeric rating scale 22,
23, 57, 65
.Total and subscale scores will be summed and transformed to a score out of 100(%).

A higher score indicates a higher level of pain and or disability.

Secondary Outcomes

1. Western Ontario Shoulder Instability Index (WOSI)

The Western Ontario Shoulder Instability Index (WOSI) is proven to be valid and reliable for
patients with shoulder instability 69. This 21-item questionnaire consists of 4 subscales:
physical symptoms (10 items), sport/recreation/work (4 items), lifestyle (4 items), and
emotions (3 items). Each item was scored on a 100-mm visual analogue scale. Total and
subscale scores will be summed and transformed to a score out of 100 (%). A higher score
indicates more limitations in shoulder related quality of life 39.

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2. Glenohumeral Internal Rotation Deficit

Glenohumeral internal rotation deficit (GIRD) is an adaptive process in which the overhead
activity shoulder experiences a loss of internal rotation (IR). GIRD has most commonly been
defined by a loss of 20° of IR compared to the contra lateral shoulder. Total rotational motion
of the shoulder is the sum of internal and external rotation and may be more important than
the absolute value of IR loss. Pathologic GIRD has been defined as a loss of IR combined
with a loss of total rotational motion 73. The leading pathologic process in GIRD is posterior
capsular and rotator-cuff tightness, due to the repetitive cocking that occurs with the
overhead throwing motion. GIRD has been associated with numerous pathologic conditions,
including posterior superior labral tears, partial articular-sided rotator-cuff tears, and superior
labral anterior-to-posterior tears. The mainstay of treatment for patients with GIRD is
posterior capsular stretching and strengthening to improve scapular mechanics. GIRD is not
a validated outcome measure; however in this study we will collect the data on it at baseline,
3 months, 6 months and 12 months.

3. EQ-5D-5L

The EQ-5D is a validated, generic and health economic self-complete patient-reported

outcome measure covering 5 health domains. The original EQ5D contained 3 response
options within each of the five domains 8,27. More recently, the EQ5D-5L has been developed
to overcome problems with ceiling effects and to improve sensitivity 5,33. The 5L version
consists of the same five domains as the original (mobility, self-care, usual activities,
pain/discomfort and anxiety/depression), but with five levels rather than three. While EQ5D-
5L has not yet been validated in this patient population, the EQ5D-3L has been validated for
a range of shoulder conditions 3, 34. The 5L version should be preferable in this patient
population and will provide a simple descriptive profile of health status that can be used to
estimate QALY scores in economic evaluations. The EQ5D-5L will be collected at baseline,
3, 6 and 12 months post randomisation.

Complications

We do not expect any complications with our interventions. However, we will collect any
complications related to the affected shoulder pain at 12 months.

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Adverse events

Adverse events will be collected over 12 months. Adverse events (AE) are defined as any
untoward medical occurrence in a clinical trial participant and which do not necessarily have
a causal relationship with the treatment. Serious adverse events (SAEs) are defined as any
untoward and unexpected medical occurrence that: 1. results in death, 2. is life-threatening,
3. requires hospitalisation or prolongation of existing rehabilitation, 4. results in persistent or
significant disability or incapacity, 5. is a congenital anomaly or birth defect, 6. includes any
other important medical condition not listed above which may require medical or surgical
intervention to prevent one of the outcomes listed.

All SAEs will be entered into a pre-designed Performa for return to the R&D office within 24
-48 hours of the investigator becoming aware of them. Once received, causality and
expectedness will be determined by the Lead Clinician. SAEs that are deemed to be
unexpected and related to the trial will be notified to the Research Ethics Committee (REC)
within 15 days for a non-life threatening event and within seven days for a life-threatening
event. For non-serious AEs, the R&D office will be notified within 5 days of the event being
known using a pre-designed Performa. AEs that may be expected with this shoulder
condition that does not need to be reported to the main REC include an increased level of
pain; delayed injury healing; conversion of planned conservative management to day case
surgery. For this trial, we will only record adverse events that are related to the affected
shoulder during the twelve-month follow-up.

Study assessments

Follow-up assessment of patients will be undertaken at 3, 6 and 12 months post-

randomisation follow-up. We will additionally collect the primary outcome SPADI and
secondary outcome measures WOSI, GIRD and EQ-5D-5L.

Data analysis

Statistical analysis plan

The flow of participants through each stage of the trial will be presented in a CONSORT
diagram 58.

Our primary analysis will compare the treatment groups at 12 months. For each of the two
treatment comparisons, the primary outcome SPADI and secondary outcome measure
WOSI, GIRD, EQ-5D-5L will be analysed using a linear mixed model, including
assessments at all available time points concerning the date of randomisation (baseline, 3, 6
and 12 months, thereby increasing power) and treating patients as a random effect. The
model will provide an overall treatment effect over 12 months as well as estimates at
individual time points. As we specify a precise sequence of tests with a priori effect sizes to
inform treatment selection, no adjustments for multiple comparisons will be made. Different
covariance patterns for the repeated measurements will be explored and the most
appropriate design will be used for the final model. Data will be assumed missing at random.
Model assumptions will be checked, and if they are in doubt, the data will be transformed
before analysis or alternative non-parametric analysis methods will be used.

The primary analysis will be conducted on an intention to treat (ITT) basis, including patients
in the groups to which they were randomised.

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Qualitative study analysis

We will use a constructivist grounded theory approach, which takes the stance that theory is
not 'discovered' but co-constructed by the researcher and participant 15 . This encourages a
flexible rather than rule-based approach to the research process that incorporates
progressively focused coding, memo writing, theoretical sampling and conceptualisation 15. A
method of constantly comparing data, codes and categories at all stages enables the
researcher to develop a theory grounded in the data 9, 15, 61. Following the conventions of the
constant comparative method 29, 61 data analysis will be carried out alongside data collection,
with interviews transcribed and analysed in batches before further data are collected. In this
way, the process is iterative with models and theories developed from ‘within’ the interviews
[rather than from existing theory or clinical practice] and tested or refined in the collection of
more data.

The analysis is iterative, moving from an initial tentative category towards a robust
theoretical group. We will use NVivo 9 to assist our organisation of qualitative analysis. This
computer programme is particularly well suited to a grounded theory approach as it allows
the researcher to begin conceptual coding as early as is felt appropriate, and to remain
flexible throughout the research process. It also allows the researcher to keep a log of
analytic decision-making and to attach team memos to conceptual categories.

Within a grounded theory study, we would expect to generate models which reflect patient
experiences of an overhead athlete with shoulder pain and its treatment, which identify
difficulties and advantages of the different treatment options. Such models are likely to focus
upon personal and lifestyle attributes as well as physical recovery and to incorporate a range
of non-clinical factors which are not routinely considered in clinical interactions. Insight into
participation in a clinical trial will also be generated.

All interviews will be analysed by the researcher conducting the interviews with a second-
team member coding a subset of interviews and commenting on the development of
conceptual categories. The aim of this is not to reach consensus but to challenge the
emerging interpretation and ensure interpretive rigour 66. We will develop our conceptual
model collaboratively in team meetings.

We will continue to interview men and women to the point of theoretical saturation in short,
until no further useful conceptual categories emerge. Theoretical sampling is used in
grounded theory to seek and collect, 'pertinent data to elaborate and refine categories in
your emerging theory' 15. Theoretical sampling allows us to explore developing theory in a
variety of samples (e.g. men versus women; different ages; dominant versus non-dominant
hand). This method of sampling does not aim to be representative of a particular population,
but is emergent, allowing analysis to move from an initial tentative category towards a robust
theoretical group 4. Although it is not possible to anticipate the exact number required, our
sample is likely to include up to 6 trial participants and 6 health care professionals. This
number is consistent with recommendations of qualitative research experts.

Dissemination and projected outputs

Plans for dissemination

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The research team have extensive experience in translating research findings into clinical
practice through the development of clear, evidence-based care pathways to improve patient
care. The experience of the research team has found translating research into clinical
practice involves the development of training packages and the findings of this research will
be incorporated to provide workshops to encourage the adoption of our recommendations
into clinical care.

The trial results will be disseminated regardless of the magnitude or direction of effect 10. A
fundamental ethical principle in clinical trials is that the potential risks incurred by study
participants should be balanced by the benefit of contributing to publicly available
knowledge. We, therefore, plan to disseminate trial results to key stakeholders and patients
in several ways:

1. The study protocol and final reports will be submitted for publication in peer-reviewed
journals. We will specifically target health professionals involved in the management of
the overhead athletes with shoulder pain, i.e., General Practitioners, Physiotherapists,
Rheumatologist, Sports Physician and Orthopaedic Surgeons.

2. Findings will be presented at key scientific meetings: the annual meeting of the British
Elbow, and Shoulder Society (BESS) Physiotherapy Research Society (PRS), and the
European Society of Shoulder & Elbow Rehabilitation (EUSSER) and their help will be
sought for dissemination and adoption of findings into clinical care.

3. Findings and reports will be made available on websites of BESS, PRS, EUUSER to
ensure this information can be accessed by consumer groups.

4. Service users will help generate patient information that is feedback directly to trial
participants, for Shared Decision Making based on findings from this trial, update the
entry on Physiopedia. In this way, service, users will actively participate in the
dissemination of the conclusions of this study in a manner that is easily accessible by
patients.

Projected Output

We intend to produce the following outputs, all of which will involve signposting those
interested in further details:

1. We shall aim to publish the clinical findings of the trial results in a high impact journal
which targets the orthopaedic, physiotherapy and musculoskeletal community.

2. To ensure that the key stakeholders such as orthopaedic surgeons and physiotherapists
are informed of the trial results we will present at a variety of conferences (e.g. BESS,
PRS,EUSSER & Physiotherapy UK conference) and provide a summary report to be
submitted through networks such as that provided by BESS and the National
Physiotherapy Research Network. Wider dissemination to other health professionals like
Rheumatologists, General Practitioners and community physiotherapists will also be
facilitated.

3. We will work with the service users to produce a short non-technical report to feedback
directly to the trial participants and to help generate patient information for Shared
Decision Making, update the entry on Wikipedia to inform the general public.

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4. There will be several other articles to publications such as the findings of the
acceptability of the treatments to patients and clinicians.

5. Publication of the findings will be press released through the collaborating Universities
and the potential for short articles in the relevant lay media explored.

6. The qualitative interviews will provide important patient-centred insight to further guide
clinical decision making for overhead athletes with shoulder pain. It will also allow us to
further understand the experience of health care treatment for this group of patients, to
improve this experience.

7. Any new intellectual property generated from the study such as the development of
training materials will be made available to all and not restricted to the NHS; and
therefore help globally to inform future clinical practice and research in the area.

8. We will explore non-academic routes to dissemination and the best format to

communicate the findings. These outputs will be co-produced with an organisation such
as patient.co.uk who specialise in supplying evidence-based information on a wide
range of medical and health topics to patients and health professionals.

We will aim to publish these findings as widely, speedily and efficiently as possible to allow
their introduction to clinical practice and for evidence-based medicine to be used in each
treatment of these patients. Our collaborative effort between health care practitioners,
researchers and patients will help to make this possible. In particular, the involvement of a
specialist in PPI and these service users will ensure that the project is patient-orientated and
relevant for the end-users. The qualitative investigation of patient experiences of the
treatment options will provide valuable patient-centred insight to guide clinical decision
making further

Project Plan

Upon ethical approval we will start the recruitment. The entire study will run for 24 months.
We will prepare the study materials, trial management database and randomisation service
before ethics approval. We acquire the local R&D approval of the four sites involved in the
study. From months 1-12, we will monitor the feasibility aspects of a pilot study at the three
sites as well as the recruitment of participants into the trial. From months 12 to 24, we will
complete patient follow-up at 12 months, complete data cleaning, undertake the clinical
effectiveness and complete the Draft Final Report.

The key milestones during this study are:

 In month 4, the first participant will be recruited into the trial;

 In month 7, the first participant will be followed-up;
 In month 12, we complete the patient recruitment, will start trial participant follow up,
begin qualitative interviews
 In month 24, we will complete the Draft Final Report.

Period (month) Activity

13
 1–3 Upon REC approval, set up for pilot sites, training clinicians across site

Initiate early recruitment study at two sites and start participant

4–9 recruitment

9 - 12 Complete recruitment

12 - 24 Complete 12 months follow up, start qualitative interviews and complete

the final draft

15. Project management

The strength of our application is that the project management will draw upon the expertise
from two institutions experienced in undertaking RCTs. The members of the research team
will meet by teleconference every 3 month from the start of the project until the end of the
study. It will be critical to achieving this regularly when setting up the study to prepare all the
study materials, set up sites to recruit and monitor recruitment progress. We will also
maintain contact via email and telephone.

There will be a Trial Management Group (TMG) to monitor the day-to-day management of
the trial. This will comprise all the co-applicants, convened by the lead applicant, and will
meet every three months via teleconference (or face-to-face as necessary) for the duration
of the study. There will be a Trial Steering Committee (TSC) to monitor the progress of the
trial and provide independent advice and a Data Management Ethics Committee (DMEC)
that will monitor the data arising from the study and recommend whether there are any
ethical or safety reasons why the trial should not continue. The TSC and DMEC will
comprise of independent clinicians and health service researchers with appropriate
expertise. Both the TSC and DMEC will meet at regular intervals to provide project oversight
to the trial. This will include monitoring the acceptability of waiting times to the study
interventions which sites will have committed to being achievable when assessing their
feasibility to take part. We will submit regular progress reports to the R&D. This project will
help to enhance further the fostering of networks that have been established between these
institutions in the design and conduct of the physiotherapy clinical trials.

16. Ethical arrangements

In the context of the lack of robust evidence to determine the best treatment for patients with
condition, the risks are not increased through trial participation. We took measures, such as
our emphasis on good practice and standardised protocols/care pathways throughout, are
likely to reduce risk and could bring additional benefits. We will emphasise the importance of
physiotherapists performing interventions of best practice advice which they undertake
regularly and with which they are familiar. We will adhere to the Research Governance
Framework and MRC Good Clinical Practice Guidance 25, 26, 51. The participant information
sheet for the study will be developed with the involvement of service users. It will give a
balanced account of the possible benefits and known risks of the interventions. It will state
explicitly that quality of care will not be compromised if the participant decides to a) not enter
the trial or b) withdraw their consent. We will make it clear that there is no obligation to

14
participate. Written informed consent will be obtained from all participants after they have
had sufficient time to read the study materials and ask any questions. An application for
ethical approval will be made through the IRAS system. We do not anticipate major ethical
concerns with this study. The only potential concern would be the inclusion of patients who
lack the mental capacity to understand the trial procedures or instructions for rehabilitation
procedures and subsequent compliance. We will allow the treating clinician to exclude these
patients from this trial. The local R&D committee of each of the participating NHS Trust will
approve local involvement in the trial. The trial will be subject to DMEC oversight.

Risks and anticipated benefits

There are no known risks for the interventions involved. Post-exercise pain flares up are
frequent, and we will advise, educate and empower participants to manage this during the
assessment for trial eligibility.

We believe that the overall risk profile is minimal for the three interventions. Still, we intend
to document the number of complications in each group as a secondary outcome of the
study. This study will deliver structured interventions with active monitoring of progress,
allowing patients to benefit from the best possible results from each of these interventions.
Establishing relative benefits of these interventions and based on that, refinement of
pathways of care in the NHS for shoulder pain mainly in overhead athletic
population/occupational group; would be a clear benefit to patients and the NHS.

The nature of the qualitative enquiry is to probe sensitive issues, and participants might find
it difficult or upsetting to talk. However, the interviews will be handled sensitively, and
patients will be assured that they can withdraw from the study at any time. The researcher
has experience in conducting this type of interview, and other patients have said that it has
been an excellent experience to talk to a researcher. Although there is no direct benefit to
participants, our previous research has demonstrated that being listened to is an essential
facet of a therapeutic encounter. We will assure patients that their decision to take part (or
not) does not affect their treatment in any way.

Informing potential trial participants of possible benefits and known risks

Informed consent will be obtained by the trained physiotherapist or clinician using a detailed
patient information sheet developed with the help of service users and explaining the risks
and benefits clearly. In the unlikely event that new information arises during the trial that
may affect participants’ willingness to take part, this will be reviewed by the TSC for addition
to the patient information sheet. A revised consent form will also be completed if necessary.

Adverse event management

15
Adverse events (AE) are defined as any untoward medical occurrence in a clinical trial
participant and which do not necessarily have a causal relationship with the treatment.
Serious adverse events (SAEs) are defined as any untoward and unexpected medical
occurrence that: 1. results in death, 2. is life-threatening, 3. requires hospitalisation or
prolongation of existing inpatients´ hospitalisation, 4. results in persistent or significant
disability or incapacity, 5. is a congenital anomaly or birth defect, 6. includes any other
important medical condition not listed above which may require medical or surgical
intervention to prevent one of the outcomes listed.

At participating sites, all SAEs will be entered into a pre-designed proforma for return to the
R&D office within 24 hours of the investigator becoming aware of them. Once received,
causality and expectedness will be determined by the Lead Clinician. SAEs that are deemed
to be unexpected and related to the trial will be notified to the Research Ethics Committee
(REC) within 15 days for a non-life threatening event and within 7 days for a life-threatening
event. For non-serious AEs, the R&D office will be notified within 5 days of the event being
known using a pre-designed proforma. AEs that may be expected with this shoulder
condition that does not need to be reported to the main REC include an increased level of
pain; delayed injury healing; conversion of planned conservative management today case
surgery. For this trial, we will only record adverse events that are related to the affected
shoulder during the twelve-month follow-up.

Proposed period for retention of relevant trial documentation

Essential Trial documentation (i.e. the documents which individually and collectively permit
evaluation of the conduct of a clinical trial and the quality of the data produced) will be kept
with the Trial Master File and Investigator Site Files. The Sponsor will ensure that this
documentation will be retained for a minimum of five years after the conclusion of the trial to
comply with standards of Good Clinical Practice. Case Report Forms will be used to record
all the information required from the protocol. These data will be stored for a minimum of five
years after the conclusion of the trial as paper records; and a minimum of 20 years in
electronic format following guidelines on Good Research Practice 10, 25. All paper records will
be stored in a secure storage facility or off-site by R&D KCHFT. All electronic files will be
stored on a password-protected server. For the qualitative interviews, recordings and
transcripts will be anonymised and kept in a locked office for three years following the
completion of the study. Interview data will only be seen by the research team, and any
quotation that could be used to identify a person would not be used in the dissemination of
findings.

16
 Patient and Public Involvement

We have worked closely with patients in previous clinical trials. For this trial, two of the lead
applicant's patients, have confirmed their interest to be involved. Mr X , co-applicant and PPI
Lead for South-East NIHR RDS, based on the lead trust, will support their learning and
development. The two patient representatives (Mr Anand & Mr Valeus) will help develop key
aspects of study protocol such as detailed patient information explaining risks and benefits of
this study clearly; consent process for trial participation; improving compliance and reducing
attrition, and commenting on Case Report Forms to ensure that all aspects of care
considered important by patients are captured. They will also advise on the web link with
video to be provided by the Lead Clinician to research staff at participating sites and for the
video and patient section of the trial website for consenting patients. They will help generate
patient information for shared decision making based on findings of this study, update the
entry on Physiopedia entry on shoulder management in overhead athletes, thus actively
participating in the dissemination of study findings which are easily accessible by patients.
Patient representatives will also be invited on to the TMG and TSC, providing patient
representation and perspective to the conduct of the trial in line with accepted good practice
63
.Their involvement will help us maintain a clear patient focus throughout the different
stages of the project.

Appendix 1
Inclusion criteria: Exclusion criteria:
Overhead athlete with
1. Aged between 18 and 55 years. 1. Bilateral concurrent frozen
shoulder pain is identified by
shoulders 17
a member of the research
2. Individuals are performing overhead 2. Secondary to trauma or other
team in an out-patient clinic.
sports for at least 3 hours per week. causes
3. Trial treatments contraindicated
3. Experienced shoulder pain in 4. Unfit for general anaesthesia
overhead activities that interfered with 5. Not resident to the catchment area
 Consent:
1. Complete Study
Eligibility Form
2. Complete Consent
Status Form
3. Complete Consent
Form
4. Complete Baseline
Eligible - Obtain consent Form SAPDI, WOSI, Not eligible:
GROC, YBT -UQ 1.Complete Study Eligibility Form
No consent: 5. Complete Contact
1. Complete Study Eligibility Form Details Form
2.Complete Consent Status Form

Integrated Kinetic
Shoulder Exercise
chain Exercise (n=15)
(n=15)
Randomise

Completion of forms at 3 months after randomisation:

1. Participant questionnaires.
2. Forms – SAPDI, WOSI, GROC, YBT -UQ
3. Post Physiotherapy booklet

Completion of forms at six months after randomisation:

1.Participant questionnaire
2. Forms – SPADI, WOSI, GROC, YBT- UQ
Qualitative study:

Completion of forms at three months after Up to 10 patients & health

randomisation: care professionals
1. Participant postal questionnaire
Patient Sampling Frame:

Treatment group
Completion of forms at 12 months after randomisation:
1. Participant postal questionnaire
2. Form – Complications

Completion of forms during the trial:

Forms – Adverse Events & Trial Withdrawals

Appendix 2 - Integrated Kinetic Chain Exercise (IKE)

18
19
Appendix 3 - Shoulder Exercises (SE)

1.

2.

20
3. 33,

4 4.

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26
Appendix 4 - SPADI

Appendix 5 - WOSI

Appendix 6 - GIRD

Appendix 7 - EQ-5 D-5 L

Appendix 8. Patient information leaflet

Appendix 9 - Study Eligibility Form

Appendix 10 - Consent Form

Appendix 11 - Consent Status Form

Appendix 12- Baseline Forms

Appendix 13- Patient contact details Form

27
28