Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Patients will be enrolled at the time of an emergency visit and followed for three months to determine outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Medications provided to patients are encapsulated. Medications vials are labelled with investigational stickers.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to ED primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
- •Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
- •Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
- •Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in the elderly.
- •Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
- •Pain duration <2 weeks (336 hours). Patients with more than two weeks of pain are at increased risk of poor pain and functional outcomes.(9)
- •Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month. Patients with more frequent back pain are at increased risk of poor pain and functional outcomes.(9)
- •Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
- •Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
排除标准
- •Not available for follow-up
- •Pregnant or breast-feeding
- •Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
- •Allergic to or intolerant of investigational medications
- •Contra-indications to non-steroidal anti-inflammatory drugs: 1) history of hypersensitivity to NSAIDs or aspirin 2) active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed 3) Severe heart failure (NYHA 2 or worse) 4) hypertension (JNC7 stage 2 or worse) 5) Chronic kidney disease 3 or worse 6) Current use of anti-coagulants 7) Hepatitis 8) Alcoholism
- •Contra-indications to muscle relaxants: 1) Concurrent use of centrally acting opioids; 2) Renal impairment; 3) Liver abnormality including cirrhosis or elevated enzymes 4) Use of any of the following medications: fluvoxamine, fluoroquinolones, amiodarone, mexiletine, propafenone, verapamil, cimetidine, famotidine, acyclovir, ticlopidine, oral contraceptive pills
研究组 & 干预措施
Tizanidine
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Tizanidine (Drug)
Metaxalone
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Metaxalone (Drug)
Metaxalone
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Ibuprofen 600 mg (Drug)
Metaxalone
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Educational intervention (Behavioral)
Tizanidine
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Ibuprofen 600 mg (Drug)
Tizanidine
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Educational intervention (Behavioral)
Baclofen
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Baclofen (Drug)
Baclofen
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Ibuprofen 600 mg (Drug)
Baclofen
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Educational intervention (Behavioral)
Placebo
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Ibuprofen 600 mg (Drug)
Placebo
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
干预措施: Educational intervention (Behavioral)
结局指标
主要结局
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)
时间窗: Baseline and 7 days
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score.
次要结局
- Number of Participants Who Experience Change in Low Back Pain(Baseline and 7 days)
- Number of Participants With Need for Medication for Low Back Pain(7 days)
- Levels of Disability(7 days)