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

NCT ID: NCT03939884

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2018-02-25

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Professional Therapy Muscle Care™ roll-on with MSM

Group Type EXPERIMENTAL

MuscleCare Topical Product

Intervention Type DRUG

Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Professional Therapy Muscle Care™ roll-on without MSM

Group Type EXPERIMENTAL

MuscleCare Topical Product

Intervention Type DRUG

Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Professional Therapy Muscle Care™ Ointment with MSM

Group Type EXPERIMENTAL

MuscleCare Topical Product

Intervention Type DRUG

Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Professional Therapy Muscle Care™ Ointment without MSM

Group Type EXPERIMENTAL

MuscleCare Topical Product

Intervention Type DRUG

Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Voltaren Emulgel

Group Type ACTIVE_COMPARATOR

Voltaren Topical

Intervention Type DRUG

Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Non-medicinal Placebo

Group Type PLACEBO_COMPARATOR

Nivea, Topical Cream

Intervention Type DRUG

Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Active and Innovative Inc.

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Jack Goodman

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jack Goodman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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University of Toronto

Toronto, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 22436614 (View on PubMed)

Other Identifiers

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MuscleCare_Voltaren

Identifier Type: -

Identifier Source: org_study_id

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