Muscle InjuryNCT04535635
Effects of ART® on Lower Limb Myofascial Pain and Function
A study testing Active Release Techniques® in people with Muscle Injury and Lower Limb Injury, run by Canadian Memorial Chiropractic College at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Muscle Injury, Lower Limb Injury
- What is being tested?
- Active Release Techniques®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2021to 2 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Any adult 20-50 years with a subacute or chronic lower myofascial injury
- Palpatory findings of a tight and tender area with a manipulatable lesion that reproduces the chief complaint (may include active vs latent trigger point)
Who cannot join
- Neurological conditions
- Degenerative joint disease of the lower limb
- Previous surgery in the area
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
SWAT Health
Mississauga, Ontario, L5G1E8
Canadian Memorial Chiropractic College Main Campus Clinic
Toronto, Ontario, M2H3J1
About this study
Official title: A Feasibility Study for a Randomized Control Trial of the Effects of Active Release Techniques® on Pain and Function of Lower Limb Myofascial Injuries
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.
Read the 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.
- Conditions
- Muscle Injury, Lower Limb Injury
- Being tested
- Active Release Techniques®, Sham Active Release Techniques®
- Keywords
- myofascial pain syndromes, Active Release Techniques®, soft tissue therapy
- Medical subject headings
- Leg Injuries, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Release Techniques®Other
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.
Sham Active Release Techniques®Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Release Techniques® | Experimental | 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. Receives: Other: Active Release Techniques® |
| Sham Active Release Techniques® | Placebo comparator | 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. Receives: Other: Sham Active Release Techniques® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Lower Extremity Functional Scale
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress, and outcome, as well as to set functional goals.
The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The LEFS is graded on an 80 point scale (score can be between 0 and 80), where a lower number equates with less disability and higher number with more disability.
Measured: This outcome measure will be used to measure the change in disability. It will be collected twice - once during the intake (prior to beginning ART® or sham) as a baseline, and then a second time following the fourth (final) treatment 2 weeks later.
Secondary outcomes (1)
Change in the Numeric Pain Rating Scale
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain over the last 24 hours was sufficient to pick up changes in pain intensity with maximal reliability. This is a 10-point scale, and the values can be any whole number between 0 and 10. Lower scores equate to less pain intensity, while higher scores indicate more pain intensity.
Measured: This outcome measure will be used to measure the change in pain intensity. It will be collected twice - once during the intake (prior to beginning ART® or sham) as a baseline, and then a second time following the fourth (final) treatment 2 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Nov 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Pajaczkowski, Canadian Memorial Chiropractic College
- Investigators
- Jason A Pajaczkowski, DC, Principal investigator, Associate Professor, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535635
- Sponsor's protocol ID
- 192031
- Status last verified
- Jul 2022
- First submitted
- 27 May 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are considering sharing the data we collected, although it will all be contained within the study itself. We will consult our research chair at the Canadian Memorial Chiropractic College for advisement.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for a Randomized Control Trial of the Effects of Active Release Techniques® on Pain and Function of Lower Limb Myofascial Injuries
- ClinicalTrials.gov ID
- NCT04535635
- Acronym / sponsor ID
- 192031
- Conditions
- Muscle Injury, Lower Limb Injury
- Keywords
- myofascial pain syndromes, Active Release Techniques®, soft tissue therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Release Techniques® | Experimental | Other: Active Release Techniques®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. |
| Sham Active Release Techniques® | Placebo comparator | Other: Sham Active Release Techniques®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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Any adult 20-50 years with a subacute or chronic lower myofascial injury
- Palpatory findings of a tight and tender area with a manipulatable lesion that reproduces the chief complaint (may include active vs latent trigger point)
Key exclusion criteria (3 listed)
- Neurological conditions
- Degenerative joint disease of the lower limb
- Previous surgery in the area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Release Techniques®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. | Other | Active Release Techniques® |
| Sham Active Release Techniques®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. | Other | Sham Active Release Techniques® |
Primary outcome
Change in the Lower Extremity Functional Scale
Time frame: This outcome measure will be used to measure the change in disability. It will be collected twice - once during the intake (prior to beginning ART® or sham) as a baseline, and then a second time following the fourth (final) treatment 2 weeks later.
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress, and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The LEFS is graded on an 80 point scale (score can be between 0 and 80), where a lower number equates with less disability and higher number with more disability.
1 secondary outcome
Change in the Numeric Pain Rating Scale
Time frame: This outcome measure will be used to measure the change in pain intensity. It will be collected twice - once during the intake (prior to beginning ART® or sham) as a baseline, and then a second time following the fourth (final) treatment 2 weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No. We are considering sharing the data we collected, although it will all be contained within the study itself. We will consult our research chair at the Canadian Memorial Chiropractic College for advisement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason A Pajaczkowski, DC principal investigator
Associate Professor, Canadian Memorial Chiropractic College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Release Techniques® in people with Muscle Injury and Lower Limb Injury, run by Canadian Memorial Chiropractic College at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Lower Extremity Functional Scale (time frame: This outcome measure will be used to measure the change in disability. It will be collected twice - once during the intake (prior to beginning ART® or sham) as a baseline, and then a second time following the fourth (final) treatment 2 weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.