Nadler 2002.
| Methods | RCT ‐ allocation method not described ‐ Setting: clinical research sites ‐ Funding: Procter and Gamble, manufacturer of heat wrap ‐ Follow‐up: 98% at Day 4 | |
| Participants | 371 participants (155M, 216F) with acute (less than 3 months) non‐specific low‐back pain; duration of pain not reported; mean age 36.0 yrs Inclusion criteria: Pain (2 or more on 6‐point scale), 18 to 55 yrs, ambulatory, no low‐back trauma within last 48 hrs, and yes to "do muscles in your low back hurt?" Exclusion criteria: Evidence or history of radiculopathy or other neurologic deficits (eg, abnormal straight‐leg‐raise test results, patellar reflexes, or bowel or bladder function), or a history of back surgery, fibromyalgia, diabetes mellitus, peripheral vascular disease, osteoporosis, gastrointestinal ulcers, gastrointestinal bleeding or perforation, renal disease, pulmonary edema, cardiomyopathy, liver disease, intrinsic coagulation defects, bleeding diseases or anticoagulant therapy (eg, warfarin), daily back pain for more than three consecutive months, or hypersensitivity to acetaminophen, NSAIDs, or heat. | |
| Interventions | 1) Heat wrap (ThermaCare Heat Wrap; Procter and Gamble) that wraps around lumbar region of torso, heats to 40 degrees C within 30 mins exposure to air & maintains this temp continuously for 8h. Worn for approx 8h per day (n = 113)
2) Oral ibuprofen: 2 tablets 3 times daily for a total dose of 1200 mg, plus oral placebo 1 time daily (n = 106)
3) Oral acetaminophen: 2 tablets 4 times daily for a total of 4000 mg dose (n = 113)
4) Oral placebo: 2 tablets 4 times daily (n = 20)
5) Unheated back wrap: (n = 19) Cointerventions not allowed |
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| Outcomes | 1) Pain: 6‐point verbal scale of pain relief
2) Muscle stiffness: 101‐point scale
3) Disability: Roland‐Morris (0 to 24 scale)
4) Lateral trunk flexibility
5) Adverse effects Timing of outcome measures: pain relief and disability measured daily for 4 days post‐randomisation |
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| Notes | Language: English Additional information from authors: Yes Author conclusions: "continuous low‐level topical heat wrap therapy is superior to both acetaminophen and ibuprofen, supporting its recommendation as a first‐line therapy for the treatment of acute muscular low back pain" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Unclear from text |
| Allocation concealment? | Unclear risk | B ‐ Unclear; allocation method not described |
| Blinding? All outcomes ‐ patients? | High risk | |
| Blinding? All outcomes ‐ providers? | High risk | |
| Blinding? All outcomes ‐ outcome assessors? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | |
| Similarity of baseline characteristics? | Low risk | |
| Co‐interventions avoided or similar? | Low risk | Cointerventions not allowed |
| Compliance acceptable? | Unclear risk | Unclear from text |
| Timing outcome assessments similar? | Low risk | |