Trial reportAnnals of emergency medicine2019
A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain.
Trial report in Annals of emergency medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Oral non-benzodiazepine muscle-relaxants for people with acute and chronic primary low back pain: a systematic review with meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025Pooled it
- The efficacy and safety of acupuncture therapy for sciatica: A systematic review and meta-analysis of randomized controlled trails.Frontiers in neuroscience · 2023Pooled it
- Efficacy, acceptability, and safety of muscle relaxants for adults with non-specific low back pain: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2021Pooled it
- Topical Diclofenac Versus Oral Ibuprofen Versus Diclofenac + Ibuprofen for Emergency Department Patients With Acute Low Back Pain: A Randomized Study.Annals of emergency medicine · 2024Trial
- A randomized controlled trial evaluating the short-term efficacy of a single-administration intramuscular injection with the fixed combination of thiocolchicoside-diclofenac versus diclofenac monotherapy in patients with acute moderate-to-severe low back pain.BMC musculoskeletal disorders · 2023Trial
- Multidisciplinary expert consensus on clinical diagnosis and therapies for low back pain.Bone research · 2026Article
- Complication Rates After Ultrasonography-Guided Nerve Blocks Performed in the Emergency Department.JAMA network open · 2024Observational
- A critical review of the role of manual therapy in the treatment of individuals with low back pain.The Journal of manual & manipulative therapy · 2024Review
- Transcending Traditional Treatment: The Therapeutical Potential of Nanovesicles for Transdermal Baclofen Delivery in Repeated Traumatic Brain Injury.Advanced pharmaceutical bulletin · 2024Article
- Impact of Prescription Medicines on Work-Related Outcomes in Workers with Musculoskeletal Disorders or Injuries: A Systematic Scoping Review.Journal of occupational rehabilitation · 2024Article
- Similarities and Differences in the Management of Patients with Osteoporotic Vertebral Fractures and Those with Rebound-Associated Vertebral Fractures Following Discontinuation of Denosumab.Journal of clinical medicine · 2023Review
- Between guidelines and clinical trials: evidence-based advice on the pharmacological management of non-specific chronic low back pain.BMC musculoskeletal disorders · 2023Review
- Rescaling pain intensity measures for meta-analyses of analgesic medicines for low back pain appears justified: an empirical examination from randomised trials.BMC medical research methodology · 2022Article
- Pharmacotherapy for Spine-Related Pain in Older Adults.Drugs & aging · 2022Review
- Efficacy and safety of oral tizanidine premedication as pre-emptive analgesia in adult patients undergoing elective surgeries- A systematic review.Saudi journal of anaesthesiaReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
STUDY
objectivePatients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and skeletal muscle relaxants. We compare functional outcomes and pain among patients with acute low back pain who were randomized to a 1-week course of ibuprofen plus placebo versus ibuprofen plus 1 of 3 skeletal muscle relaxants: baclofen, metaxalone, and tizanidine.
methodsThis was a randomized, double-blind, parallel-group, 4-arm study conducted in 2 urban emergency departments (EDs). Patients with nonradicular low back pain for less than or equal to 2 weeks were eligible if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a 24-item inventory of functional impairment caused by low back pain. All participants received 21 tablets of ibuprofen 600 mg, to be taken 3 times a day as needed. Additionally, they were randomized to baclofen 10 mg, metaxalone 400 mg, tizanidine 2 mg, or placebo. Participants were instructed to take 1 or 2 of these capsules 3 times a day as needed. All participants received a 10-minute educational session. The primary outcome was improvement on the Roland-Morris Disability Questionnaire between ED discharge and 1week later. Secondary outcomes included pain intensity 1 week after ED discharge (severe, moderate, mild, or none).
resultsThree hundred twenty patients were randomized. One week later, the mean Roland-Morris Disability Questionnaire score of patients randomized to placebo improved by 11.1 points (95% confidence interval [CI] 9.0 to 13.3), baclofen by 10.6 points (95% CI 8.6 to 12.7), metaxalone by 10.1 points (95% CI 8.0 to 12.3), and tizanidine by 11.2 points (95% CI 9.2 to 13.2). At 1-week follow-up, 30% of placebo patients (95% CI 21% to 41%) reported moderate to severe low back pain versus 33% of baclofen patients (95% CI 24% to 44%), 37% of metaxalone patients (95% CI 27% to 48%), and 33% of tizanidine patients (95% CI 23% to 44%).
conclusionAdding baclofen, metaxalone, or tizanidine to ibuprofen does not appear to improve functioning or pain any more than placebo plus ibuprofen by 1 week after an ED visit for acute low back pain.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.