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MuscleCare™ Pain Relief Therapy vs. Voltaren® in the Relief of Trapezius Trigger Point Musculoskeletal Pain.

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
MuscleCare Topical Product
Voltaren Topical
Nivea, Topical Cream
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Analgesia, Myofascial Pain, MuscleCare, Voltaren, NSAID

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 18-65 years old

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Professional Therapy Muscle Care™ roll-on with MSM

Professional Therapy Muscle Care™ roll-on without MSM

Professional Therapy Muscle Care™ Ointment with MSM

Professional Therapy Muscle Care™ Ointment without MSM

Voltaren Emulgel

Non-medicinal Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 3, 2019
Last Updated
May 6, 2019
Sponsor
University of Toronto
Collaborators
Active and Innovative Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03939884
Brief Title
MuscleCare™ Pain Relief Therapy vs. Voltaren® in the Relief of Trapezius Trigger Point Musculoskeletal Pain.
Official Title
MuscleCare™ Pain Relief Therapy vs. Voltaren® in the Relief of Trapezius Trigger Point Musculoskeletal Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
February 25, 2018 (Actual)
Study Completion Date
February 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Active and Innovative Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
Detailed Description
Myofascial pain syndromes (MPS) are common in Western society. Vernon and Schneider note that MPS is thought to be the leading diagnosis among pain management specialists and the leading diagnosis in pain patients reporting to general practitioners. MPS can be viewed as a regional pain syndrome such as, neck, low back and upper quadrant pain syndromes. MPS can also be found focally in discrete painful sites known as Myofascial Trigger Points (MTP). Locations of MTP's have been characterized on clinical grounds throughout the musculoskeletal system, starting with the seminal work of Travell and Simons. MTP's have been described as active (clinically active with pain referral upon palpation) or latent (not clinically active, but tender on manual palpation). The presence of associated features such as "local twitch sign" and palpable taut bands is thought to confirm the presence of an active MTP, while latent TP's may not present with the classic features. Numerous treatments are currently available for MPS and MTP's. Several systematic reviews have recently been published on a variety of treatments, including pharmacologic agents, physical agents, complementary and alternative therapies. One commonly used therapy is the application of topical agents to relieve pain. These agents can be classified as pharmacologic or non-pharmacologic. The former category includes non-steroidal anti-inflammatory agents (such as ketoprofen), opioid agents, classical analgesic agents (such as lidocaine), novel analgesic agents such as capsaicin and rubefascient agents (containing salicylates or nicotinamides). Non-pharmacologic agents generally fall into the complementary and alternative medicine (CAM) category for MPS and MTP treatments. They may contain putative analgesic agents or counterirritant agents and they may exert cold, hot or neutral effects. The literature on myofascial trigger points and non-pharmacologic topical agents is sparse with no randomized clinical trials found to date. Several studies have investigated the effect of such topicals in the treatment of osteoarthritis, particularly of the knee. However, there appears to be a lack of studies investigating the effects of topicas for the treatment of MPS or MTP. A randomized, placebo-blinded clinical trial of non-pharmacological topical analgesics is warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Analgesia, Myofascial Pain, MuscleCare, Voltaren, NSAID

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Professional Therapy Muscle Care™ roll-on with MSM
Arm Type
Experimental
Arm Title
Professional Therapy Muscle Care™ roll-on without MSM
Arm Type
Experimental
Arm Title
Professional Therapy Muscle Care™ Ointment with MSM
Arm Type
Experimental
Arm Title
Professional Therapy Muscle Care™ Ointment without MSM
Arm Type
Experimental
Arm Title
Voltaren Emulgel
Arm Type
Active Comparator
Arm Title
Non-medicinal Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MuscleCare Topical Product
Intervention Description
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
Intervention Type
Drug
Intervention Name(s)
Voltaren Topical
Intervention Description
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
Intervention Type
Drug
Intervention Name(s)
Nivea, Topical Cream
Intervention Description
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
Primary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
Change in pressure pain threshold by pressure algometry over the target MTP in the upper trapezius and will be reported in kg/sq.cm
Time Frame
Baseline (Pre product application) and 7 minutes post product application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 18-65 years old Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Goodman, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto
City
Toronto
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22436614
Citation
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.
Results Reference
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MuscleCare™ Pain Relief Therapy vs. Voltaren® in the Relief of Trapezius Trigger Point Musculoskeletal Pain.

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