Effects of ART® on Lower Limb Myofascial Pain and Function
Condition: Muscle Injury; Lower Limb Injury
MeSH terms: Wounds and Injuries; Leg Injuries
Study type: Interventional

Summary: 
      This is a feasibility study to determine if the investigators can conduct a clinical trial
      with a sham and control soft tissue treatment. The primary research questions are can the
      investigators provide the treatments as specified, can they recruit a sufficient number of
      participants, and does ART® decrease pain and improve function in 20-50 year-old adults with
      subacute or chronic lower limb soft-tissue injuries compared to a sham treatment? This is a
      pre-post ART® pilot study with a control group that would receive a sham ART® treatment. The
      study group is 20-50 year-old adults with subacute or chronic lower limb soft tissue
      injuries.
    

Detailed description: 
      Active Release Techniques® (ART®) is amongst the most widely utilized soft tissue techniques
      in the world. It is estimated that the 15,000 practitioners that have been certified in ART®,
      a list that includes medical doctors, chiropractors, physiotherapists, athletic therapists,
      and massage therapists, have collectively provided approximately 22 million treatments 41. In
      addition to a wealth of anecdotal information, there are numerous papers, albeit of differing
      scientific rigor, aimed at substantiating these claims. The principal investigator and
      co-investigator have authored a systematic review on all the available published research
      concerning ART® (currently seeking publication). The paucity of quality research in and of
      itself is the reason the authors have recently completed a systematic review on ART. The lack
      of quality studies begs the question for future research to determine its efficacy. Common
      issues in the existing research include: lack of sample size calculation
      14,20,28,34,48,50,54,55,59, lack of control group 6,14,20,28,50,53,54,55,59, lack of
      certified ART® providers 6,21,22,28,34,37,48,50,59,66 lack of identifiable manipulatable
      lesions14,20,21,28,48,50,59, poor inclusion/exclusion criteria 34,48,50, inappropriate
      outcome measures14,20,48,59, the use of asymptomatic study participants14,21,23,59,
      descriptive instead of inferential statistics 55,59, and using ART® for purposes other than
      which it was intended 20,21,22,48,50,59. This study being proposed will address all of these
      factors.

      Current evidence supports that the palpatory sensation of fascia softening or lengthening is
      not the result of actual elongation in the fascial sheet itself. This is because the
      requisite forces to lengthen these dense fasciae far exceed the capacity of what can be
      generated therapeutically according to Chaudry et al.7. As per Schleip, a more plausible
      mechanism is that via neurological feedback, muscles in series with the fascia being treated
      are relaxing, thereby producing the sensation of a myofascial release 56. These potential
      changes in tissue stiffness and elasticity have never been studied following a course of ART®
      treatments. Elastography has been used to measure changes in tissue stiffness following
      massage however, at present ART® has yet to be studied using this modality. The Principal
      Investigator is currently working on a joint proposal with Central Queensland University in
      Australia to produce the first study in this field.

      Sports chiropractors and athletes alike describe the benefit of Active Release Techniques®
      however, the current state of the literature is inconclusive, neither supporting nor refuting
      its effects. No studies to date have explored the relationship between the neuromuscular
      effects of ART® on the lower extremity in subacute myofascial pain with performance outcomes
      in 20-50 year-old adults. This study will contribute to the current literature on ART® and
      myofascial pain and performance in athletes, as well as the effect of ART® in symptomatic
      populations. This research adds to the body of research on one of the most widely used
      modalities in sports medicine and manual therapy. This study will further the work by Schleip
      by measuring lower limb neuromuscular function after ART® treatments. In addition, by using
      measures relating to motor control and pain, neuromuscular control becomes a construct of
      performance, where these findings can subsequently be applied to athletes and sports,
      particularly those involving running, jumping, and kicking. However, the results have
      implications for vocational endeavours as well and those experiencing lower limb discomfort.
      Riel et al found that the prevalence and incidence rates were 16.6 and 7.9 per 1000
      registered patients respectively in general practice, so lower limb myofascial injuries are
      prevalent in non-athletic populations as well 61.

      This pilot study will be, along with the author's publication of a systematic review of ART®,
      the cornerstone for proof of concept in obtaining funding for a large-scale clinical trial.
      The intent is to continue studying the efficacy of ART® across various conditions and
      athletic populations, while simultaneously beginning research on the mechanism by which ART®
      and all manual therapies affect their response.
    

Intervention name(s): Active Release Techniques®; Sham Active Release Techniques®
Intervention type(s): Other; Other
Intervention description(s): The ART® procedure will consist of identifying and treating manipulatable lesions as per their protocols, while the sham group will receive a passable version of this technique. This information is under copyright and cannot be copied or outlined specifically in any form, including a research paper. The overarching procedure used by ART® will be explained however specific details referring to each protocol cannot be described. Muscles are shortened, and the therapist applies sufficient digital pressure to be in contact with the tissue in question. Directional tension is applied proximally along the muscle fiber direction, and then the structure is lengthened while the contact remains as described.; For the sham treatment, the muscle(s) in question will be taken from a lengthened to a shortened position (opposite of the protocol direction as per the ART® manual) with a broad light contact on the skin - the treating therapist will not achieve tissue depth as specified by ART® and will not attempt to take "tension" as is outlined in the ART® manual.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will consist of two groups - one receiving ART® and the other receiving a sham. Prior to the start of the study, an independent party (Dr. Lesley Bainbridge, Associate Professor at the University of British Columbia Department of Physical Therapy, Faculty of Medicine) will perform a two-group block randomization to determine which participants will receive the sham and which will receive ART®. The assessors, Mike Edgar and Frank Astri, will be blinded to the randomization and treatment allocation. The PI, Jason Pajaczkowski, will be blinded to the randomization process but as the treating clinician, he will know into which group each new participant has been allocated only at the time of presentation when he is required to open the next allocation sequence.
The ART® procedure will consist of identifying and treating manipulatable lesions as per their protocols, while the sham group will receive a passable version of this technique.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: myofascial pain syndromes; Active Release Techniques®; soft tissue therapy