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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: MuscleCare Topical Product; Drug: Voltaren Topical; Drug: Nivea, Topical Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Active and Innovative Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2017
• Primary Completion (ACTUAL): February 25, 2018
• Study Completion (ACTUAL): February 25, 2018

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (ACTUAL): May 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Analgesia; NSAID; Myofascial Pain; Voltaren; MuscleCare
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: MuscleCare_Voltaren

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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