Effects of ART® on Lower Limb Myofascial Pain and Function

NCT04535635 | Completed DMC

• 1 other identifier: 192031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Muscle Injury; Lower Limb Injury

Keywords

myofascial pain syndromes; Active Release Techniques®; soft tissue therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

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.

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.

Other: Sham Active Release Techniques®

Interventions

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.

Active Release Techniques®

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.

Sham Active Release Techniques®

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Neurological conditions
• Degenerative joint disease of the lower limb
• Previous surgery in the area

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead

Study Sites (2)

SWAT Health

Mississauga, Ontario, L5G1E8, Canada

Location

Canadian Memorial Chiropractic College Main Campus Clinic

Toronto, Ontario, M2H3J1, Canada

Location

MeSH Terms

Conditions

Leg Injuries; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Jason A Pajaczkowski, DC

  Associate Professor, Canadian Memorial Chiropractic College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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 prior to the start of the trial. The PI will record clinical notes as per standards and include the group (ART or sham) in these notes. These notes are kept on a password-protected laptop that only he has access to. The assessors, Mike Edgar and Frank Astri, will be blinded to the randomization scheme and allocation. The participants will also be blinded to which group they are part of.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: September 2, 2020
• Study Start: November 1, 2021
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)