MuscleCare™ Pain Relief Therapy vs. Voltaren® in the Relief of Trapezius Trigger Point Musculoskeletal Pain.
1 other identifier
interventional
120
1 country
1
Brief Summary
To determine the difference in efficacy of an all natural topical analgesic (MuscleCare) to a product containing the non-steroidal anti-inflammatory drug diclofenac (Voltaren) on trapezius trigger point pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2018
CompletedFirst Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedMay 7, 2019
May 1, 2019
11 months
May 3, 2019
May 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pressure Pain Threshold
Change in pressure pain threshold by pressure algometry over the target MTP in the upper trapezius and will be reported in kg/sq.cm
Baseline (Pre product application) and 7 minutes post product application
Study Arms (6)
Professional Therapy Muscle Care™ roll-on with MSM
EXPERIMENTALProfessional Therapy Muscle Care™ roll-on without MSM
EXPERIMENTALProfessional Therapy Muscle Care™ Ointment with MSM
EXPERIMENTALProfessional Therapy Muscle Care™ Ointment without MSM
EXPERIMENTALVoltaren Emulgel
ACTIVE COMPARATORNon-medicinal Placebo
PLACEBO COMPARATORInterventions
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
Eligibility Criteria
You may qualify if:
- Between 18-65 years old
You may not qualify if:
- acute pain presentation preventing comfortable participation, absence of a palpable tender spot in the right upper trapezius region (this feature will be identified by manual palpation by a neutral assessor prior to enrollment), any history of allergic reaction to previous use of any analgesic topicals, any disorder of the skin over the right trapezius area.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Active and Innovative Inc.collaborator
Study Sites (1)
University of Toronto
Toronto, Canada
Related Publications (1)
Avrahami D, Hammond A, Higgins C, Vernon H. A randomized, placebo-controlled double-blinded comparative clinical study of five over-the-counter non-pharmacological topical analgesics for myofascial pain: single session findings. Chiropr Man Therap. 2012 Mar 21;20:7. doi: 10.1186/2045-709X-20-7.
PMID: 22436614BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack Goodman, PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 7, 2019
Study Start
March 28, 2017
Primary Completion
February 25, 2018
Study Completion
February 25, 2018
Last Updated
May 7, 2019
Record last verified: 2019-05