Author Names
Truyols-Domí Nguez, S., Salom-Moreno, J., Abian-Vicen, J., Cleland, J. A., & Fernández-de-Las-Peñas, C.
Reviewer Name
Halle Anderson, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division
Paper Abstract
Study Design: Randomized clinical trial. Objective: To compare the effects of thrust and nonthrust manipulation and exercises with and without the addition of myofascial therapy for the treatment of acute inversion ankle sprain. Background: Studies have reported that thrust and nonthrust manipulations of the ankle joint are effective for the management of patients post-ankle sprain. However, it is not known whether the inclusion of soft tissue myofascial therapy could further improve clinical and functional outcomes. Methods: Fifty patients (37 men and 13 women; mean ± SD age, 33 ± 10 years) post-acute inversion ankle sprain were randomly assigned to 2 groups: a comparison group that received a thrust and nonthrust manipulation and exercise intervention, and an experimental group that received the same protocol and myofascial therapy. The primary outcomes were ankle pain at rest and functional ability. Additionally, ankle mobility and pressure pain threshold over the ankle were assessed by a clinician who was blinded to the treatment allocation. Outcomes of interest were captured at baseline, immediately after the treatment period, and at a 1-month follow-up. The primary analysis was the group-by-time interaction. Results: The 2-by-3 mixed-model analyses of variance revealed a significant group-by-time interaction for ankle pain (P<.001) and functional score (P = .002), with the patients who received the combination of nonthrust and thrust manipulation and myofascial intervention experiencing a greater improvement in pain and function than those who received the nonthrust and thrust manipulation intervention alone. Significant group-by-time interactions were also observed for ankle mobility (P<.001) and pressure pain thresholds (all, P<.01), with those in the experimental group experiencing greater increases in ankle mobility and pressure pain thresholds. Between-group effect sizes were large (d>0.85) for all outcomes. Conclusion: This study provides evidence that, in the treatment of individuals post-inversion ankle sprain, the addition of myofascial therapy to a plan of care consisting of thrust and nonthrust manipulation and exercise may further improve outcomes compared to a plan of care solely consisting of thrust and nonthrust manipulation and exercise. However, though statistically significant, the difference in improvement in the primary outcome between groups was not greater than what would be considered a minimal clinically important difference. Future studies should examine the long-term effects of these interventions in this population. Level of evidence: Therapy, level 1b-.
NIH Risk of Bias Tool
Quality Assessment of Controlled Intervention Studies
- Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
- Yes
- Was the method of randomization adequate (i.e., use of randomly generated assignment)?
- Yes
- Was the treatment allocation concealed (so that assignments could not be predicted)?
- Yes
- Were study participants and providers blinded to treatment group assignment?
- Yes
- Were the people assessing the outcomes blinded to the participants’ group assignments?
- Yes
- Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
- Yes
- Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
- Cannot Determine, Not Reported, or Not Applicable
- Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
- Cannot Determine, Not Reported, or Not Applicable
- Was there high adherence to the intervention protocols for each treatment group?
- Yes
- Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
- Yes
- Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
- Yes
- Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
- Yes
- Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
- Cannot Determine, Not Reported, or Not Applicable
- Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
- Yes
Key Finding #1
The addition of myofascial techniques to an intervention of thrust and nonthrust joint manipulation and exercise in the treatment of acute ankle sprain leads to statistically significantly greater improvement in pain and function immediately after a 4-week intervention and at 1-month follow-up.
Key Finding #2
Patients who received the combined treatment of myofascial manual therapy, nonthrust and thrust manipulation, and exercises experienced a greater reduction in pain and a greater improvement in function than those who received the intervention of nonthrust and thrust manipulation and exercises.
Key Finding #3
The group-by-time interaction was statistically significant for all domains of the functional score, with patients who received the combined-treatment approach experiencing greater improvement on each domain compared to those in the comparison group.
Key Finding #4
Physical therapists may consider incorporating soft tissue myofascial manual techniques in the overall management of individuals with acute inversion ankle sprains.
Please provide your summary of the paper
The paper reports the results of a randomized clinical trial that aimed to compare the effects of thrust and nonthrust manipulation and exercise with and without the addition of myofascial therapy for the treatment of acute inversion ankle sprain. The study used ankle pain at rest and functional ability as primary outcome measures and found that the addition of myofascial techniques to the treatment protocol resulted in statistically significant improvement in pain and function immediately after a 4-week intervention and at 1-month follow-up. Patients who received the combined treatment experienced a greater reduction in pain and a greater improvement in function compared to those who received the intervention without myofascial techniques. The group-by-time interaction was statistically significant for all domains of the functional score, with patients who received the combined treatment approach experiencing greater improvement on each domain compared to those in the comparison group. However, the difference in improvement between the groups was not greater than what would be considered a minimal clinically important difference. The study suggests that future research should examine the long-term effects of these interventions in this population, in addition to further assessment of the clinical significance of the changes.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
Prior to this study, there was a lack of research examining the effects of myofascial techniques combined with thrust and nonthrust manipulation and exercises for patients post-acute lateral ankle sprain. Therefore, this study provided valuable insights into the potential benefits of integrating myofascial therapy into the treatment protocol for acute ankle sprains. This study provides evidence that the addition of myofascial techniques to the treatment protocol for acute inversion ankle sprain may result in improved outcomes in terms of pain reduction, functional ability, ankle mobility, and pressure pain thresholds. However, it is important to note that the difference in improvement between the groups was not greater than what would be considered a minimal clinically important difference. Therefore, clinicians should consider the potential benefits of adding myofascial techniques to the treatment protocol, but should also be aware that the clinical significance of the changes may be limited. Additionally, clinicians should be aware of the limitations of the study, including the lack of a true control group and the fact that only one therapist provided the treatment, which may limit the generalizability of the results. Therefore, future studies should include a true control group and multiple therapists delivering the intervention. Furthermore, future studies should investigate the potential influence of the placebo effect in both groups, as the study did not include a sham-intervention group.
