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

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: MuscleCare Topical Product
* Drug: Voltaren Topical
* Drug: Nivea, Topical Cream


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Professional Therapy Muscle Care™ roll-on with MSM<br> | Drug: MuscleCare Topical Product<br>* Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.<br>|
| Experimental: Professional Therapy Muscle Care™ roll-on without MSM<br> | Drug: MuscleCare Topical Product<br>* Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.<br>|
| Experimental: Professional Therapy Muscle Care™ Ointment with MSM<br> | Drug: MuscleCare Topical Product<br>* Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.<br>|
| Experimental: Professional Therapy Muscle Care™ Ointment without MSM<br> | Drug: MuscleCare Topical Product<br>* Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.<br>|
| Active Comparator: Voltaren Emulgel<br> | Drug: Voltaren Topical<br>* Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.<br>|
| Placebo Comparator: Non-medicinal Placebo<br> | Drug: Nivea, Topical Cream<br>* Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia, Myofascial Pain, MuscleCare, Voltaren, NSAID