NCT01562548已完成不适用
A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 5
- 主要终点
- Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
研究概览
简要总结
Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to investigate the evidence that guaifenesin is an effective treatment for upper back/neck/shoulder muscle spasm/stiffness and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 否
入选标准
- •Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:
- •is at least 30 days from previous episode.
- •has an onset occurred within 48 hours of Visit
- •has symptoms consistent with a clinical diagnosis as per the physical examination at Visit
- •has a subject-rated muscle spasm score and a pain score of at least 40 out of 100 on a 100mm VAS.
- •Paticipant has a normal neurological examination.
排除标准
- •Medical history: a) Paticipant has a known or suspected intolerance or hypersensitivity to guaifenesin or methocarbamol (or closely related compounds) or any of their stated ingredients. b) Paticipant has history of upper back pain with active hypersensitive spots - trigger point in the muscles of upper back/neck/shoulder/maxillofacial regions. c) Paticipant has a current or recent history of liver and/or kidney disease, neck/back/shoulder injuries, spinal disc disease, myocardial infarction (<12 months from Visit 1) and osteoporosis. d) Subjects have history of other chronic pain e.g. headache, osteoarthritis, arthritis, lower back pain etc.
- •Medications: a) Paticipant has used a muscle relaxant or narcotic within 2 weeks of Visit
- •b) Paticipant has used monoamine oxidase inhibitors or selegiline within 2 weeks of Visit 1 c) Currently using tricyclic antidepressants, lithium, anticoagulants, or tramadol.
- •Paticipant is involved in a workers compensation case.
- •Paticipant is unlikely to refrain from using analgesics, NSAIDs, and other muscle relaxants for the duration of the study, with the exception of cardioprotective doses of aspirin (i.e., ≤ 325 mg/day).
- •Paticipant is unlikely to refrain from physical therapy, massage therapy, acupuncture, heat treatment, spas, etc for the duration of the study.
研究组 & 干预措施
Arm 3
Placebo Comparator
Placebo 1 tablet BID
干预措施: Placebo (Drug)
Arm 1
Experimental
Guaifenesin 1 tablet BID
干预措施: Guaifenesin (Drug)
Arm 2
Experimental
Guaifenesin 2 tablets BID
干预措施: Guaifenesin (Drug)
Arm 4
Placebo Comparator
Placebo 2 tablets BID
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
时间窗: 7 Days
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.
次要结局
- Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores(7 Days)
- Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores(7 Days)
- Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores(7 Days)
- Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores(7 Days)
- Muscle Relaxation Scores(4 Days, 7 Days)
- Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores(Before treatment, 4 Days, 7 Days)
- Global Assessment of Treatment Helpfulness (GATH)(4 Days, 7 Days)
- Global Assessment of Sleep Disturbance (GASD)(7 Days)
- Global Assessment of Headache Frequency (GAHF)(7 Days)
- Global Assessment of Headache Intensity (GAHI)(7 Days)
研究者
研究点 (5)
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