The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Level
研究概览
简要总结
The investigators are studying whether MSM plus standard of care naproxen improves symptoms of lower back pain compared to standard of care naproxen plus placebo. Subjects will be randomized into 1 of 2 groups. Group 1 will take by mouth 6000 milligrams (mgs) of MSM plus standard of care naproxen. Group 2 will take by mouth placebo capsules plus standard of care naproxen. Subjects will be instructed to take their study pills for 12 weeks and record on a study diary. They will then be followed up for one final visit 4 weeks later. RMDQ, PIQ-6, pain level, comprehensive metabolic panel (CMP), complete blood count (CBC) will be assessed at 4 week intervals for 12 weeks. Subjects' participation will last 16 weeks.
详细描述
We will recruit male and female MOFMC DoD beneficiaries between the ages of 18-65 years old with symptoms of lower back pain from any of the clinics at the MOFMC at Nellis Air Force Base. Patients taking Muscle relaxers of any type, Non-steroidal anti-inflammatory agents (NSAIDs), Tramadol, Gabapentin, Pregabalin, agree to wash out for two weeks prior to entering the study.
Screening Visit:
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Obtain signed Informed Consent Document and HIPAA Authorization.
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Review inclusion/exclusion criteria.
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Record: name, race ethnicity, race, date of birth, age, sex, height (in inches), weight (in pounds), blood pressure, email address, phone number, history of lower back surgeries, medical history, concomitant medications, and record the amount of naproxen prescribed as standard of care.
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Subjects will have the following research-driven blood test drawn via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood drawn for each test) which include:
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Women of childbearing potential will have a serum pregnancy test.
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Comprehensive metabolic panel (liver function, renal function, plasma glucose tests).
*Subjects who have had a comprehensive metabolic panel test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.
- Complete Blood Count. *Subjects who have had a complete blood count test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.
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, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MSM 1000mg twice a day (6000 mgs)
Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen
干预措施: MSM 1000mg twice a day (6000 mgs) (Drug)
Placebo capsules twice a day
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
干预措施: Placebo capsules twice a day (Other)
结局指标
主要结局
Pain Level
时间窗: 16 weeks (Weeks 0, 4, 8, 12, and 16)
decrease in pain via analogue pain scale of 0-10 (with 10 being the worst pain)
次要结局
- Roland-Morris Disability Questionnaire(16 weeks (Weeks 0, 4, 8, 12, and 16))
- Pain Impact Questionnaire-6(16 weeks (Weeks 0, 4, 8, 12, and 16))