John C. Licciardone, Robert J. Gatchel, Subhash Aryal. Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial. J Am Osteopath Assoc 2016;116(3):156–168. doi: 10.7556/jaoa.2016.032.
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Context: Osteopathic manipulative treatment (OMT) is often used to treat patients with low back pain (LBP).
Objective: To identify subgroups of patients with chronic LBP who achieve medium to large treatment effects with OMT based on responder analyses involving pain and functioning outcomes from the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial.
Methods: This randomized, double-blind, sham-controlled trial involving 455 patients in Dallas-Fort Worth was conducted from 2006 to 2011. A 100-mm visual analog scale (VAS) for LBP intensity and the Roland-Morris Disability Questionnaire (RMDQ) for back-specific functioning were used to assess primary and secondary outcomes, respectively. Substantial improvement was defined as 50% or greater reduction at week 12 compared with baseline. Cumulative distribution functions for the RR and number-needed-to-treat (NNT) were used to assess response.
Results: Medium treatment effects for LBP intensity were observed overall (RR, 1.41; 95% CI, 1.13-1.76; P=.002; NNT, 6.9; 95% CI, 4.3-18.6). However, large treatment effects were observed in patients with baseline VAS scores of 35 mm or greater. Although OMT was not associated with overall substantial improvement in back-specific functioning, patients with baseline RMDQ scores of 7 or greater experienced medium effects, and patients with baseline scores 16 or greater experienced large effects that were significant. The OMT effects for LBP intensity and back-specific functioning were independent of baseline patient demographic characteristics, comorbid medical conditions, and medication use for LBP during the trial.
Conclusions: Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions. (ClinicalTrials.gov number NCT00315120)
a Data are given as No. (%) unless otherwise noted.
b The visual analog scale (VAS) is 100 mm, with 0 mm indicating no pain and 100 mm indicating worst possible pain.
c The Roland-Morris Disability Questionnaire (RMDQ) is a 24-point scale, with 0 indicating no disability and 24 indicating maximum disability.
Abbreviations: LBP, low back pain; OMT, osteopathic manipulative treatment.
a The area under the curve (AUC) was computed using RRs or numbers-needed-to-treat (NNTs) over the entire range of cumulative baseline scores. Smaller AUCs represent better outcomes for NNT.
Abbreviations: HTL, highest-to-lowest strategy; LBP, low back pain; LTH, lowest-to-highest strategy.
a The visual analog scale (VAS) is 100 mm, with 0 mm indicating no pain and 100 mm indicating worst possible pain.
b The Roland-Morris Disability Questionnaire (RMDQ) is a 24-point scale, with 0 indicating no disability and 24 indicating maximum disability.
c The No. (%) represent those with the given characteristic among the 193 and 215 patients, respectively, who achieved substantial improvement in low back pain (LBP) intensity and back-specific functioning.
d The ORs are adjusted for the baseline values of LBP intensity and back-specific functioning and for each variable in the table. Baseline values of LBP and back-specific functioning were not significantly associated with substantial improvement in either outcome.
Abbreviation: OMT, osteopathic manipulative treatment.
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