Critical appraisal checklist for Randomized Controlled Trials (RCT)

Article Title: Comparison of Compressive Myofascial Release and the Graston Technique for
Improving Ankle-Dorsiflexion Range of Motion

Resource:
Stanek J, Sullivan T, Davis S. Comparison of compressive myofascial release and the graston technique for improving
ankle-dorsiflexion range of motion. J Athl Train. 2018;53(2):160-167. doi:10.4085/1062-6050-386-16.

Reviewer: McKenze Thompson

Yes No Unclear NA
1. Was true randomization used for assignment of X
participants to treatment groups?
2. Was allocation to treatment groups concealed? X

3. Were treatment groups similar at the baseline? X

4. Were participants blind to treatment assignment? X

5. Were those delivering treatment blind to treatment X

assignment?
6. Were outcomes assessors blind to treatment X
assignment?
7. Were treatment groups treated identically other than X
the intervention of interest?
8. Was follow up complete and if not, were differences X
between groups in terms of their follow up adequately
9. described and analyzed?
Were participants analyzed in the groups to which X
they were randomized?
10. Were outcomes measured in the same way for X
treatment groups?
11. Were the instruments used to measure outcomes X
reliable and valid?
12. Was appropriate statistical analysis used? X
13. Was the trial design appropriate, and any deviations X
from the standard RCT design (individual
randomization, parallel groups) accounted for in the
conduct and analysis of the trial?

Overall credibility of article results per your assessment on the scale of 0-10, with 0 –“I don’t trust
the results, as the intervention study outcomes are questionable” to 10 – “I will definitely use the
results of the study in planning interventions for my patients”

Overall the score is a 9, the evidence shows that compressive myofascial release (CMR) has a
greater improvement in ROM on ankle dorsiflexion when compared to instrument assisted soft
tissue mobilization (IASTM) using Graston Technique (GT). However, other studies show similar
and contradicting results, thus I think more research should be done on this topic to have a definite
answer on which intervention is better. However, this type of intervention is safe and proven
effective, thus it can be utilized in the clinic.

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Explanation of critical appraisal of Randomized Controlled Trial (RCT)

Brief and structured summary of the article in a form of Abstract

The study done by Stanek, Sullivan, and Davis examined different therapeutic sessions on closed
chain ankle dorsiflexion range of motion. The question to be answered related to a comparison of
the effectiveness of a single session of compressive myofascial release (CMR) or instrument
assisted soft tissue mobilization (IASTM) using Graston Technique (GT) on closed chain ankle
dorsiflexion ROM. The study was a randomized control trial consisting of 3 groups (total of 44
participants): a control group, a group that received CMR, and a group that received GT. A parallel
study design and block randomization was used to compare and assign subjects to the 3 different
groups. Baseline values for closed chain ankle dorsiflexion ROM were taken with a digital
inclinometer. The subjects were evaluated in 2 different positions. The first position consisted of the
subject being in a staggered stance with the leg being evaluated in full extension. The second
position consisted of the subject being in a forward lunge position with the test leg having 90
degrees of knee flexion. The control group never received treatment and laid in a prone position for
5 minutes before post-treatment measurements were taken. The CMR group received CMR
treatment, while lying in a prone position, on the medial and lateral sides of the Achilles tendon for
1 minute and the musculotendinous junction for 2 minutes before post measurements were taken.
The GT group laid in the prone position and received treatment from the GT5 instrument for 4
minutes on areas of restriction before post measurements were taken. Results indicated that ankle
dorsiflexion ROM showed greater improvement in the standing and kneeling position for CMR
when compared to the GT and the control group after a single session of treatment. After reviewing
the article, the study showed relevant and appropriate findings. The study was able to answer the
question being examined and show quality data to support their evidence.

1. Was true randomization used for assignment of participants to treatment groups?

The final sample size consisted of 44 subjects (25 men and 19 women). Specifically, the study was
sampling 53 limbs with deficits in ankle dorsiflexion ROM. Before getting to the exact sample size,
the researchers used a power analysis to estimate that the sample size needed to be 31 subjects. The
study initially screened 82 participants before narrowing the sample size to 44 subjects.
Additionally, the ratio between men and women were not specifically looked at in the study but
based on the sample size, the ratio of men to women was about equal.

In order to determine which subjects were placed in which groups (control, CMR, and GT) subjects
were randomly assigned using a parallel study design. Additionally, the study used block
randomization, with block sizes of 3, to assign subjects to different groups.

2. Was allocation to groups concealed?

Allocation was concealed. A single session of treatment was done for this study, so there was never
an instance where a subject became aware of which stage of the treatment was next.

3. Were treatment groups similar at the baseline?

Characteristics of subjects within the 3 groups were very similar. Inclusion criteria for the study
included less then 30 degrees of closed chain ankle dorsiflexion, a Silfverskiold test indicating soft
tissue restriction, and the participant was engaged in at least 30 minutes of physical activity 3 or
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should be sent to jbisynthesis@adelaide.edu.au.
more days a week. Exclusion criteria consisted of any participant that has had ankle surgery, injury,
or were being treated for triceps surae in the last 6 months. The starting deficit among subjects
varied slightly and is shown within the article. Most of the subjects ranged within the same age,
however height and mass varied greatly among individuals.
The variance in starting ankle dorsiflexion ROM deficit could have an effect on improvements in
ROM after treatment, however the study did take the difference between the baseline measurement
and the post treatment single session measurement in both the kneeling and standing positions to
eliminate any limitations.
4. Were participants masked (or blinded) to treatment assignment?

Participants were not aware of which treatment group they were in, however, I think the subjects
could have figured it out based on the treatment they were receiving. For example, the control group
received no treatment and laid in prone for 5 minutes. The study discussed that not giving the
control group a placebo treatment could be a limitation. The study did not address whether or not
participants knew which group they were in. Subjects only received one session of treatment, so
there was not a lot of time for participants to ponder or communicate with others about which
intervention they were receiving.

5. Were those delivering treatment blind to treatment assignment?

No, the clinicians providing the intervention knew which group they we were working with,
whether it was the control, CMR, or GT group.

6. Were outcomes assessors blind to treatment assignment?

Yes, the clinician responsible for assessing the measurement outcomes for baseline and after
intervention were unaware what intervention each subject received.

7. Were treatment groups treated identically other than the intervention of interest?

Yes, all subjects completed 5 minutes of a warm up on the bicycle before receiving their
intervention. Additionally, the position of each subject (prone on a table) was the same regardless of
what group they were in.

8. Was follow up complete and if not, were differences between groups in terms of their
follow up adequately described and analyzed?

After the subjects received intervention, post treatment measures for ankle dorsiflexion ROM were
taken. However there was never a follow up days, weeks, months, etc after the treatment.

9. Were participants analyzed in the groups to which they were randomized?

Yes, after post treatment measurements were taken each subject was analysed within their own
group. A single session of treatment was done, therefore each subject fully participated in the study.

10. Were outcomes measured in the same way for treatment groups?

Yes, each group was measured using a digital inclinometer in the same 2 positions that were
assessed for baseline ankle dorsiflexion ROM. These 2 positions consisted of kneeling and standing
positions.
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should be sent to jbisynthesis@adelaide.edu.au.
 11. Were the instruments used to measure outcomes reliable and valid?

Yes. The study was examining range of motion. The study chose to use a digital inclinometer to
increase the validity of the results. However, some limitations for measurement reliability pertains
to the fact that there were 2 clinicians for the study. One clinician provided all the treatment for
CMR and the other clinician provided treatment for all the GT subjects. While having one clinician
per group increases the validity within that group, when looking across the whole study having 2
clinicians can cause limitations such as treatment technique and application of pressure on the
examined area between the 2 groups.

12. Was appropriate statistical analysis used?

Yes. In order to determine if there was a difference from the baseline measurement for each group,
the researchers subtracted the baseline measurement from the post treatment single session
measurement in both the kneeling and standing positions. Two 1-way ANOVA tests were used to
compare the changes in ROM scores between the 3 different groups.

Additionally, the study consisted of 3 subject groups: a control group, a group that received CMR,
and a group that received IASTM via GT. The study consisted of 3 independent variables and one
dependent variable. The dependent variable was range of motion. The 3 independent variables were
no therapy (control), CMR, IASTM using GT therapy. The change of ROM was dependent on the
different interventions used.

13. Was the trial design appropriate for the topic, and any deviations from the standard
RCT design accounted for in the conduct and analysis?

The trial was appropriate for a RCT due to the fact that it compared 2 different interventions on
ankle dorsiflexion ROM. The subjects within each group were randomized and unaware of what
intervention they were receiving. The trial was low cost and the findings can be implemented within
a clinical setting very easily. A cross over design should not be used for this type of trial since the
study was specifically looking at the impact of one intervention versus a different intervention on a
specific outcome. If a cross over trial were to be done, it would be unclear which intervention
method increased ankle dorsiflexion ROM.

Additional consideration

The article was found on PubMed which has a high credibility and was also published within the
Journal of Athletic Training. The authors are all certified athletic trainers with the ability to assess
joint range of motion. When comparing the results of this study with similar studies, some of the
results were consistent with other studies, while other aspects of the study were not consistent with
others. Similar findings do not show an increase in ROM for ankle dorsiflexion when manual
interventions were applied. However, the authors of this particular study contribute these
discrepancies to the fact that recent studies have not used subjects who are already experiencing
deficits in ankle dorsiflexion. Additionally, other studies have seen an increase in ankle dorsiflexion
range of motion when CMR has been applied. Lastly, the last discrepancy came when comparing
ankle dorsiflexion range of motion improvements with GT intervention. The current study showed
no change in ankle dorsiflexion ROM when GT was applied while other studies have seen
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should be sent to jbisynthesis@adelaide.edu.au.
improvements in ROM with GT intervention. These discrepancies can be contributed to different
pressures used during CMR and GT intervention. It’s evident that more research is needed to
determine if GT intervention plays a role in increasing ROM, specifically dorsiflexion.

Why you should or should not use this evidence?

The evidence shows that CMR has a greater ROM improvement for ankle dorsiflexion deficits
when compared to GT. Similar studies have seen similar results while other studies have seen
contradicting results. Based on this study, there is no physical harm done to subjects undergoing
CMR or GT, so both techniques can be used for treatment. GT intervention however showed very
little improvement in ROM for ankle dorsiflexion. More research or a prolonged study is needed to
determine which intervention is truly more beneficial. GT treatment should not be disused in
treatment, however based on this trial, CMR provides the greatest benefits for patients. Based on
this study I would use CMR to treat patients due to it being cost effective and having sound
evidence in that it increases ROM in ankle dorsiflexion.

© JBI, 2020. All rights reserved. JBI grants use of these tools for research purposes only. All other enquiries
should be sent to jbisynthesis@adelaide.edu.au.