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临床试验/NCT03939884
NCT03939884已完成4 期

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

University of Toronto1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年3月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Pressure Pain Threshold

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18-65 years old

排除标准

  • 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.

研究组 & 干预措施

Professional Therapy Muscle Care™ roll-on with MSM

Experimental

干预措施: MuscleCare Topical Product (Drug)

Professional Therapy Muscle Care™ roll-on without MSM

Experimental

干预措施: MuscleCare Topical Product (Drug)

Professional Therapy Muscle Care™ Ointment with MSM

Experimental

干预措施: MuscleCare Topical Product (Drug)

Professional Therapy Muscle Care™ Ointment without MSM

Experimental

干预措施: MuscleCare Topical Product (Drug)

Voltaren Emulgel

Active Comparator

干预措施: Voltaren Topical (Drug)

Non-medicinal Placebo

Placebo Comparator

干预措施: Nivea, Topical Cream (Drug)

结局指标

主要结局

Pressure Pain Threshold

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jack Goodman

Principle Investigator

University of Toronto

研究点 (1)

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