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ARTICLE IN PRESS

Effects of Exercise and an Integrated


Neuromuscular Inhibition Technique
Program in the Management of Chronic
Mechanical Neck Pain: A Randomized
Controlled Trial
Dimitrios E. Lytras, PT, MSc, a Evaggelos I. Sykaras, PT, PhD, a Kosmas I. Christoulas, PhD, a
Ioannis S. Myrogiannis, PT, MSc, b and Eleftherios Kellis, PT, PhD c
ABSTRACT

Objective: The aim of this study was to evaluate the effect of adding the integrated neuromuscular inhibition
technique (INIT) to therapeutic exercise (TE) in individuals with chronic mechanical neck pain (CMNP).
Methods: In this 34-week, assessor-blind randomized controlled trial, 40 participants (men and women) with CMNP
with active or latent myofascial trigger points on the neck muscles were divided into 2 groups. The participants
followed 4 treatments per week for 10 weeks. The intervention group followed a TE program in combination with the
INIT, whereas the control group followed the same program without the INIT. Both protocols were applied by
physiotherapists. Pain, disability, pressure pain threshold, active range of motion, and health-related quality of life
were evaluated before, during, and after the intervention, whereas patients were followed for 6 months after
completion of treatment. Repeated-measures ANOVA was applied.
Results: Both groups showed a significant improvement in all dependent measures after the intervention (P < .05).
However, the intervention group showed greater improvement in the visual analog scale and neck disability index
score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health
Survey score, than the control group. In many of the above variables this improvement was seen from the second week
and was maintained for 6 months after the intervention.
Conclusion: The results of this preliminary study suggest that the addition of the INIT to a TE program had a positive
effect on pain, functionality, and the quality of life in individuals with CMNP. (J Manipulative Physiol Ther
2020;00;1-14)
Key Indexing Terms: Exercise; Neck Pain; Therapy; Soft Tissue

TAGEDH1INTRODUCTIONTAGEDEN
Neck pain shows a high rate of recurrence and chronic-
ity. Three out of 10 neck pain patients will develop chronic
symptoms that last more than 6 months,1,2 whereas 34%
a
Laboratory of Ergophysiology, Department of Physical Edu- will show symptoms for more than 12 months.3 Chronic
cation and Sports Sciences, Aristotle University of Thessaloniki, mechanical neck pain (CMNP) is characterized by a persis-
Thermi Thessaloniki, Greece.
b
Laboratory of Hygiene Medical Statistics, School of Medi-
tence of symptoms for a period longer than 3 months.4 The
cine, Aristotle University of Thessaloniki, University Campus, exact origin and pathophysiological mechanisms of chronic
Thessaloniki, Greece. neck pain remain unclear. Many researchers have linked
c
Laboratory of Neuromechanics, Department of Physical chronic symptoms to changes in neck muscles.5-7 Individu-
Education and Sport Science at Serres, Aristotle University of als with CMNP exhibit muscle weakness and reduced
Thessaloníki, Agios Ioannis Serres, Greece.
Corresponding author: Dimitrios E. Lytras, PT, MSc, Depart-
endurance in the neck flexor muscles compared to healthy
ment of Physical Education and Sports Sciences, Aristotle Univer- adults,8 which is highly associated with pain and
sity of Thessaloniki, 57001 Thermi Thessaloniki Greece. disability.8,9
(e-mail: lytrasde@gmail.com). Therapeutic exercise (TE) has proven to be beneficial to
Paper submitted June 16, 2018; in revised form January 29, individuals with CMNP.1,2,9,10-13 Improvement of neck
2019; accepted March 1, 2019.
0161-4754
muscle strength and endurance has been associated with
© 2020 by National University of Health Sciences. pain reduction and improved functional capacity. Six
https://doi.org/10.1016/j.jmpt.2019.03.011 weeks of TE in people with CMNP resulted in short-term
ARTICLE IN PRESS
2 Lytras et al Journal of Manipulative and Physiological Therapeutics
Management of Chronic Mechanical Neck Pain 2020

effects by reducing pain and improving neck muscle weak- than the muscle energy technique in improving pain,
ness and isometric strength,14 but these effects do not seem disability, and range of motion (ROM) in individuals with
to remain after 6 months. In contrast, Ylinen et al13 neck pain, whereas Sibby et al33 suggested that the INIT
reported long-term benefits with pain reduction and disabil- is equally effective with laser application in upper trapezius
ity improvement following a 12-month TE program. MTrPs.
The TE programs of individuals with CMNP often The INIT, based on the phenomenon of reciprocal inhibi-
involve resistance and endurance training for neck and tion and post-isometric relaxation, can resolve muscle spasm
shoulder muscles. The combination of both is a more com- in painful areas29,30 and thus could be optimally combined
plete approach with better results.4,13,15,16 with TE in muscles housing MTrPs. The combination of TE
Many researchers have pointed out the therapeutic value and manipulation, mobilization, or connective tissue mas-
of combining TE with manual therapies.2,17,18 Miller et sage has been employed recently for treating CMNP.19,34-38
al16 reported that the combination of exercise and manipu- However, the combination of TE and a MTrPs deactivation
lation or mobilization of the cervical and thoracic spine technique has not been widely applied. The purpose of this
brought better short- and medium-term reduction of pain study was to evaluate the effect of adding INIT to a TE pro-
and disability than the application of each type separately. gram for management of CMNP. The hypothesis of this
However, in studies that have implemented a combination study was that the combination of INIT and TE yields
of exercise and manipulation in contrast to manipulation greater improvement in pain, disability, neck muscle tender-
only, it is not clear whether the differences identified ness, neck ROM, and quality of life of patients with CMNP
between the groups are due to the exercise alone or to the than TE alone. To better monitor treatment effects, several
particular combination.19 Thus, the appropriate choice of intermediate measurements were performed.
techniques and dosage requires further investigation.18
Many researcher studies associate neck pain with the
presence of myofascial trigger points (MTrPs) in the neck
TAGEDH1METHODSTAGEDEN
muscles.20-22 MTrP has been defined as a hyperirritable
spot within a taut band of skeletal muscle fibers painful on Design
compression.23 It has been shown that in people with This was an assessor-blind, randomized controlled trial
chronic neck pain there are almost always more trigger (clinicaltrials.gov number: NCT02802189). Two experi-
points in more than 1 muscle. Cerezo-Tellez et al20 in a enced physiotherapists applied the 2 protocols, the first was
study of 2000 patients with chronic neck pain found that all responsible for supervising and conducting the exercise
participants displayed trigger points in the cervical muscles program and the second was implementing the INIT and
with a higher incidence of trigger points in the upper trape- relaxation exercises. It was not possible for care providers
zius. However, although the occurrence rate is so high, few or participants to be unaware of group allocation. A masked
studies in chronic neck pain have used a combination of assessor conducted the measurements.
exercise and MTrPs deactivation techniques.21,24 This por- Participants signed an informed consent and were ran-
trays an important literature gap in the research field of domly divided into 2 groups. Group allocation was per-
manual therapy. The presence of MTrPs in individuals formed by using opaque sealed envelopes, and concealed
experiencing chronic pain is associated with increased allocation was attained with the following procedure: Con-
intramuscular electromyographic activity of the agonist25 secutively numbered, opaque envelopes with coded treat-
and antagonist26 muscles during synergistic muscle activa- ment assignment cards were created off-site by the
tion and with increased muscle fatigue during isometric statistician prior to the start of enrollment, using a 1:1 allo-
muscle contraction.27 At the same time, Ylinen et al28 cation ratio and randomly mixed permuted blocks of differ-
reported that people with chronic neck pain have decreased ent sizes. The randomization schedule and block sizes were
values in strength and endurance in all muscle groups of concealed from the team of the study. Randomization took
the neck compared with healthy individuals. For this rea- place at the end the first visit. If the patient met the entry
son, this specific combination of exercise and trigger point criteria, the envelopes were opened in consecutive order by
deactivation technique presents a research interest. study staff in the presence of the patient. The statistician
The integrated neuromuscular inhibition technique (INIT) prepared the files and secured the random distribution of
is a manual MTrPs deactivation technique, which has been the people in the groups. In order to ensure that the partici-
described by Chaitow.29,30 It includes the combination of pants of both groups would spend the same treatment time
the ischemic compression technique, the strain-counter- with their therapist, and get the same level of care, the con-
strain technique, and the muscle energy technique. Sadaat trol group received an extra 15 minutes of breathing exer-
et al31 reported that 1 session of the INIT is able to reduce cise and gentle stretching to balance the 15-minute INIT
pain and pressure pain threshold (PPT) in individuals with program that was applied in the intervention group. This
CMNP due to MTrPs in the upper trapezius muscle. study abides by the Code of Ethics of the World Medical
Nagrale et al32 claimed that the INIT is more effective Association (Declaration of Helsinki).
ARTICLE IN PRESS
Journal of Manipulative and Physiological Therapeutics Lytras et al 3
Volume 00, Number 00 Management of Chronic Mechanical Neck Pain

Participants inside the envelope was coded using the letters A and B
Forty outpatients, men and woman, aged 30 to 60 years and, therefore, patients and assessors were blind to the
diagnosed with CMNP were recruited from a rehabilitation group allocation during baseline assessment. Participants
center between June 2016 and March 2017. Inclusion crite- underwent 4 sessions per week for 10 weeks. Measure-
ria were symptoms with a duration of at least 3 months, ments were performed at an extra (fifth) visit after the treat-
existence of at least 1 active or latent MTrP in any of the ment sessions for the week. There were no missed visits or
levator scapulae, upper trapezius, splenius capitis (SC), and missed measurement visits. Even if a participant for any
sternocleidomastoid (SCM) muscles, diagnoses by radio- reason missed a planned visit, it was rescheduled within
diagnostic tests (x-ray or magnetic resonance imaging), the same week (often made on Saturdays). Any other treat-
and medical referral for physiotherapy. ment for the neck or shoulder area during the intervention
Exclusion criteria were severe neck pain confirmed by period was not allowed.
visual analog scale (VAS) (score >70 mm), treatment dur-
ing the past 3 months (physiotherapy, anesthetic blocks,
etc), participation in a neck muscle exercise program dur- Measurements
ing the past 6 months, neck surgery, chronic progressive All measurements were conducted in the baseline week
inflammatory diseases leading to joint damage (rheumatoid and in the second, fourth, sixth, 10th, 14th, 22nd, and 34th
arthritis and ankylosing spondylitis), joint infections, and weeks of the intervention (VAS, ROM, and PPT). Excep-
history of malignancy in the cervical region. tions were the neck disability index (NDI) measurements
(performed in the baseline, sixth, 10th, 14th, 22nd, and
34th weeks) and the 36-Item Short Form Health Survey
Procedure (SF-36) measurements (taken in the baseline, 10th, 14th,
The general study design is illustrated in a flowchart 22nd, and 34th weeks).
(Fig 1). During the first meeting, individuals were asked to Pain intensity. Pain was assessed by the VAS, which is
rate their pain intensity on a VAS. Furthermore, a masked a card with an uncalibrated scale ranging from 0 to 100
assessor examined the neck and shoulder region to identify (with 0 representing no pain and 100 representing the high-
at least 1 latent or active MTrP. After the primary screen- est level of pain imaginable). A vertical line on the scale
ing, for every patient who met the inclusion criteria, a drawn by the patient marked their subjective pain estima-
sealed envelope was opened in consecutive order by study tion ranging from 0 to 100 mm. Subsequently, a single
staff in the presence of the patient. Each envelope con- ruler was used to record the exact pain level. Hence, the
tained the group allocation sheet and general information higher the value, the more intense the pain.39 The psycho-
concerning the study procedure. Baseline measurements metric characteristics of the VAS make it easy to apply,
were recorded on a second visit. The group allocation sheet and as a consequence, its use is extensive.39,40 The

Fig 1. CONSORT flow diagram of the study. CONSORT, Consolidated Standards of Reporting Trial.
ARTICLE IN PRESS
4 Lytras et al Journal of Manipulative and Physiological Therapeutics
Management of Chronic Mechanical Neck Pain 2020

reliability of the scale is quite satisfactory, especially in questions, selected from the Medical Outcomes Study.
people with moderate and high educational levels (r = .94, These questions are related to 8 different parameters of
P = .001) than the less educated (r = .71, P = .001).41 mental and physical health. Similar to the NDI, SF-36 has
Disability. Disability was evaluated using the NDI satisfactory support in the literature.51 Total Physical and
questionnaire.42 It is a self-reported 10-item scale. Each Mental Health, and the subcategory of Bodily Pain, were
item assesses different neck pain complaints. Most of the evaluated in this study. SF-36 shows a high rate of validity
items are related to restrictions in activities of daily life, and reliability in patients with neck pain.46,52,53 In all 8 cat-
and each item is expressed by 6 different assertions in the egories, both the ICC and the Cronbach's alpha index are
range 0 to 5, with 0 indicating no disability and 5 indicating high (0.75-0.94 and 0.69-0.88, correspondingly).46
the highest disability. The total score ranges from 0 to 50.
The NDI has satisfactory support in the literature, being the
most commonly used to report neck pain.43,44 Its credibility Interventions
in people with neck pain is moderate to high and has been Intervention group. A combination of TE and the INIT
considered a valid tool in patients with neck problems.2 was applied in the intervention group (IG). The exercise
Cleland et al45 reported moderate reliability in mechanical program included endurance and resistance training exer-
neck pain patients (intraclass correlation [ICC], 0.50), cises for the neck and scapula muscles and lasted 45
whereas Juul et al46 report high reliability (ICC 0.97) and minutes. This program was based on that of Jull et al.54
good internal validity (Cronbach’s alpha = 0.86). Each session included retraining of the longus colli and
Neck muscles pressure pain threshold. The pressure pain endurance training of the deep cervical flexors; neck mus-
threshold (PPT) is defined as the minimal amount of pres- cle ROM exercises in all directions; resistance exercises for
sure that produces pain. Pressure algometry was conducted the neck and the upper limb muscles between 12 and 15
using a Wagner digital algometer (Wagner FPX 25 Digital repetitions maximum with resistance bands; isometric exer-
Algometer; Wagner Instruments, Greenwich, CT). PPT cise for the muscles involved in neck flexion, extension,
was assessed bilaterally over the upper border of the trape- side bending, and rotation (20%-70% of maximum volun-
zius muscle, halfway between the midline and the lateral tary contraction); and stretching exercises for the neck and
border of the acromion, the levator scapulae muscle 2 cm upper limb muscles. More details about this program are
above the lower insertion and located in the upper medial available at https://ebm.bmj.com/content/suppl/2003/08/
border of the scapulae, the SCM upper insertion, and the 08/8.4.109.DC1/84109authorreply.pdf.
SC 2 cm lateral to the spinous processes of the axis. This The INIT protocol was sequentially applied for 15
selection was made according to Ylinen et al.47 The metal minutes. The technique was implemented based on the
rod of the algometer was placed vertically on the site, and instructions of Chaitow and DeLany29 as follows.
the examiner applied gradually increasing pressure at a rate
of 1 kg/s. The examinees indicated when they began to feel 1. Ischemic compression: After MTrPs identification,
pain or discomfort. Then, the examiner ceased the pressure ischemic compression was applied in an intermittent
and noted the value. Pressure algometry showed from satis- manner for up to 2 minutes for each MTrP. The pincer
factory to fairly high reliability by various researchers both grasp (for the trapezius muscle and SCM) or direct
in repeated measurements of the same examiner and digital pressure (for the levator scapulae and SC mus-
between measurements of different examiners.5,48-50 cle) was used with the patients in either the supine
Cervical ROM. Active range of motion was measured position or sitting upright.
with 2 bubble inclinometers (Baseline Bubble Inclinome- 2. Strain-counterstrain technique: When general or local
ter, White Plains, NY). One was placed on the top of the pain began to diminish, the muscle was placed in a
head and the second on the spinous process of C7. Active position of ease and was held for approximately 20 to
cervical flexion, extension, and side-bending ROM were 30 seconds. Moderate digital pressure was applied to
assessed with participants sitting in the upright position. the identified MTrP as participants rated their level of
Both inclinometer dials had to be adjusted to 0 before the pain on a scale ranging from 1 to 10. Ease was defined
participant started moving. The participant was then as the point at which a reduction in pain of at least
instructed to perform the movement while the hands of the 70% was achieved. Once the position of ease was
examiner followed without moving the centers of the identified, it was held for 20 to 30 seconds.
inclinometers. The total range was derived from the mathe- 3. Muscle energy technique: After the ease position was
matical difference between the 2 inclinometers. The bubble maintained for 20 to 30 seconds, an isometric contrac-
inclinometer showed moderate to satisfactory reliability in tion focused on the muscle fibers around the MTrP
neck ROM measurements with ICC ranging from 0.66 to was performed. Each isometric contraction was held
0.84.2,45 for 7 to 10 seconds and was followed by a soft-tissue
Quality of Life. The short form of SF-36 Health Survey stretch. Each stretch was held for 30 seconds, and it
questionnaire was used in this study. SF-36 consists of 36 was repeated 3 times during the treatment session. The
ARTICLE IN PRESS
Journal of Manipulative and Physiological Therapeutics Lytras et al 5
Volume 00, Number 00 Management of Chronic Mechanical Neck Pain

treatment was performed on the 3 most painful areas education of patients on the benefits of cervical muscle exer-
between the upper border of the trapezius muscle, the cise was provided to the participants of both groups at
SCM, the levator scapulae, and the SC muscle. Muscle the beginning of the study. According to O'Riordan et al,4
selection was conducted after a palpating examination the fear of suffering pain and the lack of knowledge of exer-
before each treatment session. cise benefits are strictly connected with the non-adherence to
exercise. The briefing was made both verbally by the mem-
Control group. The CG performed the same exercises bers of the research team and in writing with information on
excluding the application of INIT. At the end of the exer- exercise benefits described in the consent form. When the
cise program, a relaxing breathing exercise and gentle participants completed their treatment phase, they were
stretching were applied for 15 minutes. instructed to continue their exercise at home and recommen-
dations were made to avoid sedentary lifestyles. In general,
the compliance of the participants with the program was sat-
Statistical Analysis isfactory. There were no missed care visits or evaluation ses-
Data were analyzed using SPSS Statistics for Windows, sions during the treatment phase. Two patients from the IG
version 23.0 (SPSS Inc, Chicago, IL). For each outcome and 2 patients from the CG voluntarily dropped out of the
parameter, normal distribution was checked with the Sha- study for personal reasons after the 22nd week (between the
piro-Wilk test. A 2-way analysis of variance (ANOVA) 22nd and 34th weeks) (Fig 1). Demographic features of both
was applied to examine the interaction effect of “group” groups are summarized in Table 1. The prevalence of MTrPs
(IG and Control Group [CG]) and “time of measurement” during the initial evaluation is summarized in Figure 2.
(weeks 1, 2, 4, 6, 10, 14, 22, and 34) on each dependent
measure. Fewer time points were measured for NDI score
(weeks 1, 6, 10, 14, 22, and 34) and SF-36 (weeks 1, 10, Outcome Measures
14, 22, and 34). All follow-ups were included in the model. Visual Analog Scale. The 2-way ANOVA analysis dis-
The overall comparisons between groups were made using played a significant “group” £ “time” interaction effect
the “group” £ “time” interaction effects. If the interaction (P < .001) for the visual analog scale (VAS) score;
was statistically significant, the simple main effects were whereas, a main effect on the “time” factor was observed
reported using the Tukey post hoc test (HSD). The 95% (P < .001) (Table 2). Tukey’s (HSD) post hoc test dis-
confidence intervals of the group differences at each time played a significant difference between groups in the VAS
point were also calculated. score from the second week until the 34th week (P < .05,
Intention-to-treat analysis methodology was used to 95% CI). The above analysis shows that the VAS score
avoid the effect of dropouts in order not to disrupt the ran- was significantly reduced in both groups. However, this
domized group assignment of the study. All participants reduction was greater in the IG, 70% by the 10th week
were included in the analysis and they were analyzed in the ( 38.14 mm) vs 46% ( 24.5 mm) reduction in the CG
original group assigned. For each drop out during the inter- (relative to baseline). The difference in the IG appeared
vention period, the missing values were replaced with the from the second week, whereas the reduced values
value of each variable from the previous time point. Statis- remained statistically significant until the 32nd week.
tical significance was accepted at a level of .05. Neck Disability Index. The 2-way ANOVA analysis dis-
A total sample size of at least 32 subjects was recruited played a significant “group” £ “time” interaction effect
based on an a priori power analysis (G*Power 3.0.10). As (P < .001) for the NDI score, whereas a main effect on the
a basic prerequisite for this calculation, the power (1-b) “time” factor was observed (P < .001) (Table 2). Tukey’s
was set at 95%, and the detection of a difference in the (HSD) post hoc test displayed a significant difference
order f = .5 (Cohen’s f).55 Because this was a preliminary between groups in the NDI score from the sixth week until
study, the alpha was set at .05 for all tests. At the same the 34th week (P < .05, 95% CI). The earlier analysis
time, an additional 10% was added to the calculated sample shows that the NDI score declined more after the interven-
size for each follow-up measurement performed after the tion in the IG than the CG. In the IG, it decreased by
intervention (weeks 14, 22, 34). 46.7% (13 points) in the 10th week, whereas in the CG it
decreased by 28.6% (8 points).
Pressure Pain Threshold. A significant “group” x “time”
interaction and a main effect on “time” measurements for
TAGEDH1RESULTSTAGEDEN
all PPT muscles were observed (P < .05) (Table 3). From
Participants Tukey’s (HSD) post hoc test, a significant difference
During the recruitment period 62 individuals applied for between groups in the PPT values was noted. Increased
evaluation. Of these, 8 people refused to participate in the values for the right upper trapezius were noted from the
research and 14 did not meet the inclusion criteria. Forty second week until the 34th week and for the left SC from
were randomly assigned to the 2 groups. Counseling and the fourth week until the 34th week (P < .05, 95% CI).
ARTICLE IN PRESS
6 Lytras et al Journal of Manipulative and Physiological Therapeutics
Management of Chronic Mechanical Neck Pain 2020

Table 1. Demographics of the 2 Groups “Time” factor was measured in all ROM measurements
Demographics Intervention Group Control Group (P < .05) (Table 4). From Tukey’s (HSD) post hoc test,
greater improvement of ROM was noted in the IG only for
Age (y) 46.8 (8.85) 45.8 (7.73)
the left-side-bend ROM from the sixth week until the 10th
Sex 25% (n = 5) 25% (n = 5) week, and for the extension ROM only in the 34th week
(P < .05, 95% CI). There were no differences between the
(Men/Women) 75% (n = 15) 75% (n = 15) groups at any time point for the flexion range and right-
side-bend (P > .05) measurements (P < .05, 95% CI).
Duration of symptoms (mo)
SF-36 Health Survey Questionnaire. The 2-way ANOVA
3-6 60% (n = 12) 35% (n = 7) analysis displayed a significant “group” £ “time” interac-
tion and a main effect on measurements of the “time” fac-
6-12 35% (n = 7) 35% (n = 7) tor in all 3 variables (P < .05) (Table 5). Tukey’s (HSD)
post hoc test displayed a significant difference between
More than 12 5% (n = 1) 30% (n = 6)
groups in the “Total Physical Health” score and the
Employment 65% (n = 13) 65% (n = 13) “Bodily Pain” score in the IG from the 10th week until the
34th week (P < .05, 95% CI). In "Total Physical Health,"
(yes/no) 35% (n = 7) 35% (n = 7) the IG score increased in the 10th week (compared with
the baseline measurement) by 50.44% (+20.05), whereas
Sedentary job 75% (n = 15) 80% (n = 16)
the CG score increased by 21.04% (+8.25). In “Total Men-
(yes/no) 25% (n = 5) 20% (n = 4) tal Health,” the IG scored higher only in the 34th week
(P < .05, 95% CI).
Working h/wk

Less than 20 35% (n = 7) 30% (n = 6)


TAGEDH1DISCUSSIONTAGEDEN
Between 20-40 25% (n = 5) 30% (n = 6)
The results of this study suggest that both groups experi-
More than 40 40% (n = 8) 40% (n = 8) enced a clinically meaningful improvement in all the varia-
bles examined during the intervention period. However,
H of computer work/wk
the IG showed greater improvement in several variables
0-5 per wk 35% (n = 7) 20% (n = 4) over CG. This provides support to our hypothesis that the
addition of the INIT to TE may be beneficial for treating
5-10 per wk 5% (n = 1) 10% (n = 2) patients with CMNP.
The VAS score was reduced in both groups during the
10-20 per wk 25% (n = 5) 20% (n = 4)
intervention period. However, this reduction was greater in
More than 20 per wk 35% (n = 7) 50% (n = 10) the IG in all follow-ups (Table 2). The percentage reduction
observed in the VAS score in this study is much greater
Sports 30% (n = 6) 35% (n = 7) than in other similar studies in which the combinations of
exercise and manipulation,19,36,38 mobilization,56 or soft
(yes/no) 70% (n = 14) 65% (n = 13)
tissue massage34 were applied. The efficiency of INIT is
Previous physiotherapy 95% (n = 19) 85% (n = 17) based on the mechanism of reciprocal inhibition and posti-
sometric relaxation to resolve muscle spasm and reduce
(yes/no) 5% (n = 1) 15% (n = 13) pain.29,30 Exercise, on the other hand, is capable of effec-
tively reducing pain in people with CMNP, but this effect
is not acute; it takes approxinaely 6 weeks for pain adapta-
The values for the 10th week increased for the right trape- tions to occur.4 Furthermore, in the early stages of applica-
zius in the IG by 61.61% (+1.83kg/cm2) compared with tion of exercise, caution is needed because of prolonged
an increase of 39.06% (+1.09kg/cm2) in the CG, and for immobilization of the spasming muscles, which are likely
the left SC by 50.62% (+1.62 kg/cm2) compared with to react to painful exercise and create a further spasm, acti-
37.74% (+1.17 kg/cm2) in the CG. An increase in the PPT vating TrPs.4,23 It is possible that the implementation of
of the SCM and the levator scapulae (right and left) was INIT further enhanced the positive effect of exercise.
observed only in the fourth and in the sixth week (P < Perhaps its application immediately after exercise reduced
.05, 95% CI). the pain that preexisted owing to muscle spasms and also
Active ROM. In all ROM measurements, except flexion prevented further worsening of muscle spasms as a result
(P < .05), a statistically significant “Group” x “Time” of exercise. This reduction in the VAS score also has
interaction was found. Furthermore, a main effect on the clinical significance57 because the differences between the
ARTICLE IN PRESS
Journal of Manipulative and Physiological Therapeutics Lytras et al 7
Volume 00, Number 00 Management of Chronic Mechanical Neck Pain

80%
70%
60%
50%
40%
30%
20%
10%
0%
Trapezius Trapezius Levator Levator SC Right SC Le SCM Right SCM Le
right Le Scapulae Scapulae
Right Le

Fig 2. Prevalence of trigger points in the whole sample in the baseline assessment.Trapezius right = 67%; trapezius left = 43%; leva-
tor scapulae right = 14%; levator scapulae left = 9%; SC right = 34%; SC left = 29%; SCM right = 18%; SCM left = 14%.

Table 2. VAS Score (mm) and Mean (SD) NDI Scores of the Intervention Group and Control Group for Each Time Point
Baseline Week 2 Week 4 Week 6 Week 10 Week 14 Week 22 Week 34
VAS in mm (SD)

IG 54.32 (8.71) 33.27 (9.40)a 23.62 (8.09)a 19.32 (9.45)a 16.18 (6,18)a 17.87 (6.36)a 19.34 (7.1)a 19.74 (5.63)a

CG 53.67 (10.13) 43.37 (10.04) 37.87 (8.44) 33.07 (9.32) 29.27 (7.98) 28.07 (8.86) 30.87 (8.88) 32.90 (8.47)

P value .82 .02 .00 .00 .00 .00 .00 .00

95% CI ( 5.40 to 6.70) ( 16.32 to 3.87) ( 19.54 to 8.95) ( 19.76 to 7.73) ( 17.66 to 8.51) ( 15.14 to 5.26) ( 16.68 to 6.38) ( 17.76 to -8.55)

NDI (SD)

IG 27.80 (4.77) 19.16 (4.93)a 14.75 (4.56)a 16.26 (5.22)a 17.6 (5.27)a 18.35 (6.58)a

CG 27.90 (4.93) 23.35 (7.27) 20.15 (5.72) 22.05 (6.53) 23.5 (5.78) 24.40 (6.62)

P value .94 .04 .00 .00 .00 .00

95% CI ( 2.98 to 2.78) ( 8.17 to 0.20) ( 8.71 to 2.08) ( 9.57 to 2.00) ( 9.44 to 2.35) ( 10.27 to 1.82)

The 95% CI of the group differences and the corresponding P values are also presented.
CG, control group; CI, confidence intervals; IG, intervention group; NDI, neck disability index; SD, standard deviation; VAS, visual analog scale.
a
Between groups significant comparisons in the post hoc testing.

groups were quite large (a difference of 13.09 mm at the owing to pain in this group. The reduction in the NDI score
10th week). This reflects both the lower levels of pain of observed in this study is consistent with similar studies of
IG participants after completion of the exercise program 10 to 12 weeks duration in subjects with CMNP.19,36-38
and the smoother adaptation of the cervical muscles to the However, the results of this study contrast those reported
exercise at the beginning of the program. by Evans et al,36 who did not identify differences in the
The NDI score also declined more after intervention in NDI score between the groups when comparing the effect
the IG than the CG (Table 2). This might reflect differences of the combination of exercise and manipulation to the
in changes in pain levels between the 2 groups during the effect of exercise alone. The differences between the 2
intervention period. Falla et al9 stated that prolonged neck groups in NDI score are also of clinical importance. Pool et
pain is associated with decreased functionality in individu- al58 stated that the minimal clinically important change on
als with CMNP. Probably the greater reduction in pain in the NDI score in individuals with neck pain is 10.5 points.
the IG is also responsible for fewer functional limitations IG had a 13.5-point change in score in the 10th week
8
Management of Chronic Mechanical Neck Pain
Lytras et al
Table 3. Mean (SD) Pressure Pain Threshold kg/cm2 of the Intervention Group and Control Group for Each Time Point
Baseline Week 2 Week 4 Week 6 Week 10 Week 14 Week 22 Week 34
PPT kg/cm2

Right trapezius PPT

IG 2.97 (0.41) 3.5 (0.52)a 4.0 (0.59)a 4.56 (0.84)a 4.80 (0.95)a 4.61 (0.96)a 4.53 (0.84)a 4.4 (0.87)a

CG 2.79 (0.25) 3.04 (0.42) 3.07 (0.45) 3.49 (0.84) 3.88 (0.818) 3.79 (0.8) 3.74 (0.76) 3.54 (0.83)

P value .10 .00 .00 .00 .00 .00 .00 .00

95% CI ( 0.37 to 0.40) (0.15-0.76) (0.62-1.30) (0.52-1.61) (0.35-1.49) (0.25-1.38) (0.26-1.30) (0.31-1.41)

Left trapezius PPT

3.81 (0.48)a 4.17 (0.61)a 4.47 (0.74)a 4.62 (0.75)a 4.33 (0.74)a

ARTICLE IN PRESS
IG 3.42 (0.42) 4.74 (0.69) 4.54 (1.09)

CG 3.34 (0.41) 3.36 (0.46) 3.55 (0.54) 3.8 (0.66) 4.16 (0.75) 4.14 (0.75) 4.05 (0.73) 3.83 (0.84)

P value .51 .00 .00 .05 .01 .05 .10 .05

95% CI ( 0.18 to 0.35) (0.15-0.76) (0.24-0.98) (0.21-1.12) (1.18-1.04) ( 0.00 to 0.96) ( 0.11 to 1.08) ( 0.01 to 1.00)

Right levator scapulae PPT

IG 4.6 (0.98) 5.04 (0.84) 5.74 (0.97)a 6.37 (1.21)a 7.32 (1.43) 7.02 (1.13) 7.04 (1.44) 6.87 (1.29)

CG 4.43 (0.73) 4.61 (0.86) 4.77 (1.08) 5.15 (1.01) 6.48 (1.21) 6.56 (1.14) 6.51 (1.81) 6.23 (1.25)

P value .52 .11 .00 .00 .06 .24 .20 .12

Journal of Manipulative and Physiological Therapeutics


95% CI ( 0.37 to 0.73) ( 0.11 to 0.97) (0.30-1.60) (0.50-1.93) ( 0.00 to 1.69) ( 0.32 to 1.25) ( 0.31 to 1.37) ( 0.17 to 1.45)

Left levator scapulae PPT

IG 4.61 (1.0) 4.91 (0.9) 5.63 (0.94) 6.3 (0.98)a 7.23 (1.1) 6.94 (1.12) 6.72 (1.0) 6.84 (1.1)

CG 4.53 (0.85) 4.56 (0.86) 4.74 (0.94) 5.43 (1.10) 6.52 (1.24) 6.44 (1.11) 6.33 (1.99) 6.33 (1.2)

P value .77 .22 .00 .01 .06 .17 .28 .16

95% CI ( 0.51 to 0.68) ( 0.21, to 0.91) (0.28-1.50) (0.19-1.54) (0.04-1.46) ( 0.22 to 1.20) ( 0.33 to 1.10) ( 0.22 to 1.25)

(continued)

2020
Volume 00, Number 00
Journal of Manipulative and Physiological Therapeutics
Table 3. (Continued)
Baseline Week 2 Week 4 Week 6 Week 10 Week 14 Week 22 Week 34
Right SC PPT

IG 2.92 (0.37) 3.34 (0.58) 3.8 (0.76)a 4.16 (0.82) 4.75 (0.82) 4.64 (0.78) 4.56 (0.73) 4.27 (0.79)

CG 2.85 (0.32) 3.1 (0.43) 3.16 (0.5) 3.72 (0.66) 4.26 (0.86) 4.08 (0.8) 3.98 (0.8) 3.82 (0.79)

P-Value .54 .13 .00 .07 .07 .32 .22 .08

95% CI ( 0.15 to 0.29) ( 0.08 to 0.57) (0.22-1.05) ( 0.44 to 0.91) ( 0.05 to 1.03) (0.05-1.06) (0.08-1.07) ( 0.05 to 0.95)

Left SC PPT

IG 3.2 (0.44) 3.43 (0.47) 3.89 (0.77)a 4.59 (0.86)a 4.82 (0.79)a 4.76 (0.76)a 4.75 (0.89)a 4.39 (0.71)a

ARTICLE IN PRESS
CG 3.1 (0.37) 3.22 (0.52) 3.4 (0.56) 3.78 (0.85) 4.27 (0.79) 4.23 (0.69) 4.00 (0.76) 3.99 (0.75)

P value .44 .19 .02 .05 .03 .03 .00 .02

95% CI ( 0.16 to 0.36) ( 0.11 to 0.53) (0.06-0.92) (0.25-1.35) (0.43-1.06) (0.58-0.99) (0.21-1.28) (0.06-1.00)

Right SCM PPT

IG 2.78 (0.7) 3.02 (0.93) 3.61 (1.0)a 4.63 (1.24)a 5.5 (1.14) 5.18 (1.12) 4.90 (1.09) 4.57 (1.00)

CG 2.55 (0.72) 2.68 (0.98) 2.93 (1.06) 3.69 (1.11) 5.18 (1.31) 4.95 (1.18) 4.53 (1.16) 4.20 (1.03)

P value .31 .27 .04 .01 .41 .53 .30 .26

95% CI ( 0.22 to 0.68) ( 0.27 to 0.95) (0.00-1.36) (0.18-1.69) ( 0.47 to 1.11) ( 0.50 to 0.96) ( 0.35 to 1.08) ( 0.28 to 1.01)

Management of Chronic Mechanical Neck Pain


Left SCM PPT

IG 3.06 (0.79) 3.52 (0.84) 3.95 (1.02) 4.79 (1.02)a 5.62 (1.11) 5.53 (1.07) 5.35 (1.05) 5.15 (1.05)

CG 2.75 (0.85) 3.13 (1.0) 3.48 (1.26) 3.96 (1.27) 5.45 (1.31) 5.21 (1.180) 5.07 (1.16) 4.81 (1.19)

P value .24 .20 .20 .03 .65 .36 .42 .38

95% CI ( 0.22 to 0.83) ( 0.21 to 0.98) ( 0.26 to 1.20) (0.82-1.56) ( 0.60 to 0.95) ( 0.39 to 1.04) ( 0.43 to 0.99) ( 0.37 to 1.06)
The 95% CI of the group differences and the corresponding P values are also presented.

Lytras et al
CG, control group; CI, confidence intervals; IG, intervention group; PPT, pressure pain threshold; SC, splenius capitis; SCM, sternocleidomastoid; SD, standard deviation.
a
Between groups significant comparisons in the post hoc testing.

9
ARTICLE IN PRESS
10 Lytras et al Journal of Manipulative and Physiological Therapeutics
Management of Chronic Mechanical Neck Pain 2020

Table 4. Mean (SD) ROM Degrees of the Intervention Group and Control Group for Each Time Point
Baseline Week 2 Week 4 Week 6 Week 10 Week 14 Week 22 Week 34
Flexion ROM°

IG 47.25 (4.01) 49.5 (5.68) 51.9 (5.49) 53.85 (4.51) 54.0 (5.21) 53.45 (4.76) 52.1 (4.98) 51.35 (5.27)

CG 49.0 (2.26) 49.1 (7.77) 49.7 (6.93) 52.6 (5.88) 53.7 (5.84) 52.45 (5.56) 51.25 (5.57) 50.85 (5.91)

P value .18 .85 .27 .45 .86 .54 .61 .77

95% CI ( 4.40 to 0.90) ( 3.96 to 4.70) ( 1.80 to 6.20) ( 2.10 to 4.60) ( 3.24 to 3.84) ( 2.31 to 4.31) ( 2.53 to 4.23) ( 3.08 to 4.08)

Extension ROM°

IG 55.2 (5.11) 58.05 (6.1) 60.1 (6.0) 61.65 (5.64) 63.0 (5.46) 61.85 (5.86) 61.20 (5.65) 61.6 (5.44)a

CG 56.3 (5.5) 57.25 (6.14) 57.5 (6.41) 59.55 (5.81) 61.0 (5.28) 59.75 (5.77) 58.95 (5.66) 57.8 (5.28)

P value .51 .68 .19 .25 .24 .26 .21 .03

95% CI ( 4.50 to 2.30) ( 3.12 to 4.72) ( 1.39 to 6.59) ( 1.56 to 5.76) ( 1.44 to 5.44) ( 1.62 to 5.82) ( 1.37 to 5.87) ( 0.36 to 7.23)

Right bend ROM°

IG 37.25 (2.98) 38.35 (3.67) 39.05 (3.72) 40.05 (3.80) 40.85 (3.45) 39.45 (3.51) 38.90 (3.62) 38.85 (2.73)

CG 38.45 (3.21) 38.5 (3.7) 39.1 (3.43) 39.7 (3.37) 39.85 (3.11) 38.85 (2.94) 38.45 (3.15) 37.60 (2.87)

P value .22 .89 .96 .76 .34 .56 .67 .16

95% CI ( 3.18 to 0.78) ( 2.51 to 2.21) ( 2.34 to 2.24) ( 1.95 to 2.65) ( 1.10 to 3.10) ( 1.47 to 2.67) ( 1.72 to 2.62) ( 0.54 to 3.04)

Left bend ROM°

IG 32.0 (4.71) 33.85 (4.24) 36.55 (4.31) 38.85 (4.14)a 40.95 (3.95)a 39.35 (3.58) 38.90 (3.97) 38.25 (4.06)

CG 32.6 (4.77) 33.65 (4.09) 34.05 (4.28) 35.6 (3.93) 38.6 (2.89) 38.8 (3.75) 37.65 (2.92) 36.75 (3.25)

P value .61 .88 .07 .01 .03 .63 .26 .21

95% CI ( 3.63 to 2.43) ( 2.47 to 2.87) ( 0.25 to 5.25) (0.66-5.83) (0.13-4.56) ( 1.79 to 2.89) ( 0.98 to 3.48) ( 0.88 to 3.88)

The 95% CI of the group differences and the corresponding P values are also presented.
CG, control group; CI, confidence intervals; IG, intervention group; NDI, neck disability index; ROM, range of motion; SD, standard deviation.
a
Between groups significant comparisons in the post hoc testing.

compared with the baseline measurement, whereas the CG show that the IG participants experienced lower levels of
changed only by 7.75 points (Table 2). This difference in pain in these 2 muscles from the beginning of the interven-
NDI score reflects the reduction in the disability of IG indi- tion. It is worth noting that the trapezius and SC were the
viduals, which, according to many researchers, is associ- muscles with the highest prevalence of MTrPs in all the
ated with prolonged care, increased treatment costs, and a participants.
negative impact on the health system.2,4,13 Regarding the PPT of the levator scapulae and the ster-
Our results showed statistically significant differences nocleidomastoid, the results showed a better improvement
between the groups in the PPT values of all the examined of the IG group over the CG group only in intermediate fol-
muscles. Larger differences were found in the trapezius low-ups (in the fourth and sixth weeks) (Table 3). Individu-
and SC from the second week, which were maintained until als in the IG probably had MTrPs in these muscles, and the
the 34th week (Table 3). The factors that may have contrib- combination of the INIT and exercise helped to reduce pain
uted to this result are unclear. The application of ischemic more rapidly. In subsequent follow-ups, however, the CG
pressure at the TrPs of these 2 muscles possibly has group displayed the same pain threshold increase as the IG
contributed to their inactivation, thus reducing the local group, probably owing to the effect of the exercise.
tenderness of these muscles from the beginning.59 The dif- According to O’Riordan et al4 an exercise period of at least
ferences identified between the 2 groups were large enough 6 weeks is required for the first neck muscle adaptations.
to be considered clinically important.49 These differences Therefore, it is reasonable to suggest that exercise
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Journal of Manipulative and Physiological Therapeutics Lytras et al 11
Volume 00, Number 00 Management of Chronic Mechanical Neck Pain

Table 5. Mean (SD) SF-36 Scores of the Intervention Group and Control Group for Each Time Point
Baseline Week 10 Week 14 Week 22 Week 34
SF-36 score

Total physical health

IG 39.75 (3.81) 59.80 (8.89)a 59.65 (8.60)a 57.45 (8.66)a 55.30 (7.90)a

CG 39.20 (4.0) 47.45 (7.57) 47.05 (6.93) 45.15 (6.43) 44.10 (6.71)

P value .65 .00 .00 .00 .00

95% CI ( 1.95 to 3.05) (7.06-17.63) (7.59-17.60) (7.41-17.18) (6.50-15.89)

Total mental health

IG 44.30 (3.68) 59.90 (9.36) 58.40 (7.47) 57.25 (8.56) 55.55 (6.52)a

CG 43.75 (5.52) 54.20 (9.08) 55.15 (7.59) 52.60 (7.44) 50.10 (7.58)

P value .71 .06 1.81 .07 .02

95% CI ( 2.46 to 3.56) ( 0.20 to 11.60) ( 1.57 to 8.07) ( 0.48 to 9.78) (0.92-9.97)

Bodily pain

IG 41.90 (5.99) 66.40 (10.41)a 64.15 (6.93)a 61.30 (7.29)a 58.95 (7.30)a

CG 42.40(6.75) 54.35 (9.57) 52.90 (9.19) 51.65 (9.94) 51.35 (9.48)

P value .80 .00 .00 .00 .00

95% CI ( 4.58 to 3.58) (5.64-18.45) (6.03-16.47) (4.06-15.23) (2.18-13.02)


The 95% CI of the group differences and the corresponding P values are also presented.
CG, control group; CI, confidence intervals; IG, intervention group; SD, standard deviation; SF-36, short form 36.
a
Between-group significant comparisons in the post hoc testing

adaptations after the sixth week contributed to reduction of longer period of time, but further research is essential to
the local muscle tenderness in CG individuals. The selec- verify such a suggestion. The findings of this study are in
tive application of the INIT to the 3 most painful muscles line with some research studies supporting the positive
after each exercise session helped reduce the local tender- effect of exercise on the ROM of patients with
ness of these muscles more rapidly. Nevertheless, it appears CMNP.13,19,49 However, they are in contrast with the find-
that the INIT has no additional benefit for the levator scap- ings of Bronfort et al19 who did not notice differences
ulae and the sternocleidomastoid PPTs compared with TE between groups in the ROM when comparing the combina-
alone. tion of exercise and manipulation to exercise alone. Collec-
Regarding the neck ROM, the IG showed greater tively, our results suggest that the addition of the INIT
improvement in the left side bending ROM than the CG offered some additional benefits in the ROM, but these
only between the sixth and 10th week (Table 4). This may were diminished 6 months after the intervention. These
be due to the fact that most of the participants exhibit benefits do not appear to carry a meaningful clinical signifi-
MTrPs in the right trapezius (Fig 2), which is responsible cance because the differences found between the groups,
for restricting the ROM of the side bending to the opposite although statistically significant, were actually negligible
side.23 Thus, it is possible that the application of the INIT (from 2.3 to 3.8 degrees difference, Table 4).
to the trapezius contributed to the deactivation of the The results of this study showed that the IG displayed a
MTrPs of this particular muscle. In addition, there were greater improvement in “Total Physical Health” and “Bodily
similar responses to interventions in cervical extension Pain” throughout the intervention period (Table 5). These dif-
ROM; only in the 34th week measurement point did the IG ferences can be attributed to the different levels of pain expe-
group show a greater increase than the CG. This improve- rienced by the 2 groups during the intervention period.
ment of the IG might indicate that the participants were Concerning the subcategory “Total Mental Health,” the IG
able to maintain the positive effect of the exercise for a showed a greater improvement than the CG only during the
ARTICLE IN PRESS
12 Lytras et al Journal of Manipulative and Physiological Therapeutics
Management of Chronic Mechanical Neck Pain 2020

34th week. This implies that although both groups showed a TAGEDH1CONTRIBUTORSHIP INFORMATIONTAGEDEN
gradual (small but continuous) decrease in values during the
Concept development (provided idea for the research):
intermediate measurement sessions (Table 5), the IG retained
D.E.L., E.I.S., K.I.C., E.K.
positive effects in “Total Mental Health” for longer than the
Design (planned the methods to generate the results):
CG. The differences between the 2 groups were quite large.
D.E.L., E.I.S., K.I.C., I.S.M., E.K.
At 10 weeks, the score of “Total Physical Health” in IG par- Supervision (provided oversight, responsible for organiza-
ticipants had increased by 20 points compared with the initial
tion and implementation, writing of the manuscript):
measurement, whereas in the CG the corresponding increase
D.E.L., E.I.S., K.I.C., E.K.
was only 8.2 points. The corresponding increases in the
Data collection/processing (responsible for experiments,
“Bodily Pain” score at week 10 were 24.5 in the IG and only
patient management, organization, or reporting data):
12 in the CG (Table 5). These differences between groups
D.E.L., E.I.S., I.S.M.
mean that IG participants felt healthier after completing the
Analysis/interpretation (responsible for statistical analysis,
program. Although the effect of exercise on the quality of life
evaluation, and presentation of the results): D.E.L., I.S.M.,
of individuals with CMNP is known,15,60 the increase in the E.K.
SF-36 score observed in this study was much greater than in
Literature search (performed the literature search): D.E.L.,
other similar studies.36,61 Additionally, the findings of this
I.S.M.
study contrast those of Celenay et al,34 who compared the
Writing (responsible for writing a substantive part of the
combination of exercise and massage of connective tissue to
manuscript): D.E.L., I.S.M., E.K.
exercise alone and found differences between the groups
Critical review (revised manuscript for intellectual content,
only in “Total Mental Health.” The results of our study sug-
this does not relate to spelling and grammar checking): E.K.
gest that the addition of the INIT offered some additional
benefits to health-related quality of life in IG individuals.
These benefits seem to be related more to “Total Physical
Health” and “Bodily Pain.”
Practical Applications
Limitations  The therapeutic combination of TE and INIT
This was a preliminary study with a limited capability of on neck muscles have better short-term and
enrolling individuals with CMNP. The relatively small sam- medium-term positive effects in pain, disabil-
ple size and recruitment of the participants from the same ity, muscle sensitivity, ROM, and the quality
rehabilitation center did not allow the formation of an INIT- of life than TE alone in patients with CMNP.
 Therapeutic exercise benefits could be obtained
only group in order to determinate the influences of the exer-
cise protocol. Furthermore, there is the possibility of a sam- more quickly and to a greater extent when
pling error because of the many outcomes without adjusted combined with the MTrPs deactivation tech-
alpha error levels. Another limitation concerns the fact that nique.
 More studies including TE and MTrPs deacti-
neither the care providers nor the participants could be blind
to the study. In addition, the INIT was applied to only 3 vation techniques should take place in the
muscles in each session for study purposes, and this could not future in patients with CMNP.
satisfy 100% of the concerns of the IG patients; they may
have had symptoms in more than 3 muscles on both sides of
the body.

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ARTICLE IN PRESS
14 Lytras et al Journal of Manipulative and Physiological Therapeutics
Management of Chronic Mechanical Neck Pain 2020

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