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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03939884
Recruitment Status : Completed
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Active and Innovative Inc.
Information provided by (Responsible Party):
Jack Goodman, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Pain Drug: MuscleCare Topical Product Drug: Voltaren Topical Drug: Nivea, Topical Cream Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: MuscleCare™ Pain Relief Therapy vs. Voltaren® in the Relief of Trapezius Trigger Point Musculoskeletal Pain.
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : February 25, 2018
Actual Study Completion Date : February 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Professional Therapy Muscle Care™ roll-on with MSM Drug: MuscleCare Topical Product
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Experimental: Professional Therapy Muscle Care™ roll-on without MSM Drug: MuscleCare Topical Product
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Experimental: Professional Therapy Muscle Care™ Ointment with MSM Drug: MuscleCare Topical Product
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Experimental: Professional Therapy Muscle Care™ Ointment without MSM Drug: MuscleCare Topical Product
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Active Comparator: Voltaren Emulgel Drug: Voltaren Topical
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Placebo Comparator: Non-medicinal Placebo Drug: Nivea, Topical Cream
Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.




Primary Outcome Measures :
  1. Pressure Pain Threshold [ Time Frame: Baseline (Pre product application) and 7 minutes post product application ]
    Change in pressure pain threshold by pressure algometry over the target MTP in the upper trapezius and will be reported in kg/sq.cm



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939884


Locations
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Canada
University of Toronto
Toronto, Canada
Sponsors and Collaborators
University of Toronto
Active and Innovative Inc.
Investigators
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Principal Investigator: Jack Goodman, PhD University of Toronto
Publications:
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Responsible Party: Jack Goodman, Principle Investigator, University of Toronto
ClinicalTrials.gov Identifier: NCT03939884    
Other Study ID Numbers: MuscleCare_Voltaren
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Jack Goodman, University of Toronto:
Analgesia
Myofascial Pain
MuscleCare
Voltaren
NSAID
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action