Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial.

PURPOSE: We studied the efficacy of osteopathic manual treatment (OMT) and ultrasound therapy (UST) for chronic low back pain. METHODS: A randomized, double-blind, sham-controlled, 2 × 2 factorial design was used to study OMT and UST for short-term relief of nonspecific chronic low back pain. The 455 patients were randomized to OMT (n = 230) or sham OMT (n = 225) main effects groups, and to UST (n = 233) or sham UST (n = 222) main effects groups. Six treatment sessions were provided over 8 weeks. Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at week 12 (30% or greater and 50% or greater pain reductions from baseline, respectively). Five secondary outcomes, safety, and treatment adherence were also assessed. RESULTS: There was no statistical interaction between OMT and UST. Patients receiving OMT were more likely than patients receiving sham OMT to achieve moderate (response ratio [RR] = 1.38; 95% CI, 1.16-1.64; P <.001) and substantial (RR = 1.41, 95% CI, 1.13-1.76; P = .002) improvements in low back pain at week 12. These improvements met the Cochrane Back Review Group criterion for a medium effect size. Back-specific functioning, general health, work disability specific to low back pain, safety outcomes, and treatment adherence did not differ between patients receiving OMT and sham OMT. Nevertheless, patients in the OMT group were more likely to be very satisfied with their back care throughout the study (P <.001). Patients receiving OMT used prescription drugs for low back pain less frequently during the 12 weeks than did patients in the sham OMT group (use ratio = 0.66, 95% CI, 0.43-1.00; P = .048). Ultrasound therapy was not efficacious. CONCLUSIONS: The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial.

PURPOSE: To assess response to osteopathic manual treatment (OMT) according to baseline severity of chronic low back pain (LBP). METHODS: The OSTEOPATHIC Trial used a randomized, double-blind, sham-controlled, 2×2 factorial design to study OMT for chronic LBP. A total of 269 (59%) patients reported low baseline pain severity (LBPS) (<50 mm/100 mm), whereas 186 (41%) patients reported high baseline pain severity (HBPS) (≥50 mm/100 mm). Six OMT sessions were provided over eight weeks and outcomes were assessed at week 12. The primary outcome was substantial LBP improvement (≥50% pain reduction). The Roland-Morris Disability Questionnaire (RMDQ) and eight other secondary outcomes were also studied. Response ratios (RRs) and 95% confidence intervals (CIs) were used in conjunction with Cochrane Back Review Group criteria to determine OMT effects. RESULTS: There was a large effect size for OMT in providing substantial LBP improvement in patients with HBPS (RR, 2.04; 95% CI, 1.36-3.05; P<0.001). This was accompanied by clinically important improvement in back-specific functioning on the RMDQ (RR, 1.80; 95% CI, 1.08-3.01; P=0.02). Both RRs were significantly greater than those observed in patients with LBPS. Osteopathic manual treatment was consistently associated with benefits in all other secondary outcomes in patients with HBPS, although the statistical significance and clinical relevance of results varied. CONCLUSIONS: The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

Osteopathic manual treatment in patients with diabetes mellitus and comorbid chronic low back pain: subgroup results from the OSTEOPATHIC Trial.

CONTEXT: Chronic pain is often present in patients with diabetes mellitus. OBJECTIVE: To assess the effects of osteopathic manual treatment (OMT) in patients with diabetes mellitus and comorbid chronic low back pain (LBP). DESIGN: Randomized, double-blind, sham-controlled, 2×2 factorial trial, including OMT and ultrasound therapy (UST) interventions. SETTING: University-based study in Dallas-Fort Worth, Texas. PATIENTS: A subgroup of 34 patients (7%) with diabetes mellitus within 455 adult patients with nonspecific chronic LBP enrolled in the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. MAIN STUDY MEASURES: The Outpatient Osteopathic SOAP Note Form was used to measure somatic dysfunction at baseline. A 100-mm visual analog scale was used to measure LBP severity over 12 weeks from randomization to study exit. Paired serum concentrations of tumor-necrosis factor (TNF)-α obtained at baseline and study exit were available for 6 subgroup patients. RESULTS: Key osteopathic lesions were observed in 27 patients (79%) with diabetes mellitus vs 243 patients (58%) without diabetes mellitus (P=.01). The reduction in LBP severity over 12 weeks was significantly greater in 19 patients with diabetes mellitus who received OMT than in 15 patients with diabetes mellitus who received sham OMT (mean between-group difference in changes in the visual analog scale pain score, -17 mm; 95% confidence interval [CI], -32 mm to -1 mm; P=.04). This difference was clinically relevant (Cohen d=0.7). A corresponding significantly greater reduction in TNF-α serum concentration was noted in patients with diabetes mellitus who received OMT, compared with those who received sham OMT (mean between-group difference, -6.6 pg/mL; 95% CI, -12.4 to -0.8 pg/mL; P=.03). This reduction was also clinically relevant (Cohen d=2.7). No significant changes in LBP severity or TNF-α serum concentration were associated with UST during the 12-week period. CONCLUSION: Severe somatic dysfunction was present significantly more often in patients with diabetes mellitus than in patients without diabetes mellitus. Patients with diabetes mellitus who received OMT had significant reductions in LBP severity during the 12-week period. Decreased circulating levels of TNF-α may represent a possible mechanism for OMT effects in patients with diabetes mellitus. A larger clinical trial of patients with diabetes mellitus and comorbid chronic LBP is warranted to more definitively assess the efficacy and mechanisms of action of OMT in this population.

Depression, somatization, and somatic dysfunction in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial.

CONTEXT: Depression and somatization are often present in patients with chronic low back pain (LBP). OBJECTIVES: To measure the presence of depression and somatization in patients with chronic LBP and to study the associations of depression and somatization with somatic dysfunction, LBP severity, back-specific functioning, and general health. DESIGN: Cross-sectional study using baseline measures collected within a randomized controlled trial. SETTING: University-based study in Dallas-Fort Worth, Texas. PATIENTS: A total of 202 adult research participants with nonspecific chronic LBP. MAIN STUDY MEASURES: Depression was self-reported and also measured with the Modified Zung Depression Index (MZDI). Somatization was measured with the Modified Somatic Perception Questionnaire (MSPQ). The MZDI and MSPQ scores were used to classify patients as "normal," "at risk," or "distressed" using the Distress and Risk Assessment Method. Somatic dysfunction was assessed using the Outpatient Osteopathic SOAP Note Form. A 100-mm visual analog scale (VAS), the Roland-Morris Disability Questionnaire (RMDQ), and the Medical Outcomes Study Short Form-36 Health Survey (SF-36) were used to measure LBP severity, back-specific functioning, and general health, respectively. RESULTS: There were 53 patients (26%) and 44 patients (22%) who were classified as having depression on the basis of self-reports and the MZDI cut point, respectively. A total of 38 patients (19%) were classified as having somatization on the basis of the MSPQ cut point. There were significant correlations among self-reported depression and the MZDI and MSPQ scores (P<.001 for each pairwise correlation). Similarly, the MZDI and MSPQ scores were both correlated with LBP severity and back-specific disability, and they were inversely correlated with general health (P<.001 for each pairwise correlation). Depression and the number of key osteopathic lesions were also each correlated with back-specific disability and inversely correlated with general health (P<.001 for each pairwise correlation). The MZDI (P=.006) and MSPQ (P=.004) scores were also correlated with the number of key osteopathic lesions. CONCLUSIONS: The associations among depression, somatization, and LBP in this study are consistent with the findings of previous studies. These associations, coupled with the findings that MZDI and MSPQ scores are correlated with somatic dysfunction, may have important implications for the use of osteopathic manual treatment in patients with chronic LBP.