Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain

A Randomized Controlled Trial

John C. Licciardone, DO, MS, MBA; Dennis E. Minotti, DO; Robert J. Gatchel, PhD; Cathleen M. Kearns, BA; Karan P. Singh, PhD

Disclosures

Ann Fam Med. 2013;11(2):122-129. 

In This Article

Results

Patient Flow and Characteristics

Baseline patient characteristics were comparable across main effects groups (Table 1). The patient flow diagram displays similar allocation to physicians, follow-up, and treatment adherence among main effects groups (Supplemental Figure 1, available at http://annfammed.org/content/11/2/122/suppl/DC1). A total of 397 (87%) patients attended the final encounter at week 12.

Low Back Pain Outcomes

The repeated measures analysis of variance failed to reject the hypothesis of no interaction between OMT and UST (P = .34). This analysis further showed significant reductions in pain scores on the visual analog scale over time with OMT compared with sham OMT (P = .002), but not with UST compared with sham UST (P = .99). Correspondingly, the change scores on the visual analog scale at 12 weeks for OMT patients (median = –18 mm, IQR = –31 to 0 mm) were significantly better than for sham OMT patients (median = –9 mm, IQR = –25 to 3 mm (P = .002). There was no statistical interaction between OMT and UST in assessing moderate (T = –0.04; 95% CI, –0.22 to 0.14; P = .63) or substantial (T = –0.05; 95% CI, –0.23 to 0.13; P = .61) improvements in low back pain.

Overall, 145 (63%) OMT patients vs 103 (46%) sham OMT patients reported moderate improvement at week 12 (RR = 1.38; 95% CI, 1.16–1.64; P <.001). Similarly, 114 (50%) OMT patients vs 79 (35%) sham OMT patients reported substantial improvement (RR = 1.41; 95% CI, 1.13–1.76; P = .002). By contrast, moderate improvement was observed in 128 (55%) UST patients vs 120 (54%) sham UST patients (RR = 1.02; 95% CI, 0.86–1.20; P = .85). Substantial improvement was observed in 103 (44%) UST patients vs 90 (41%) sham UST patients (RR = 1.09; 95% CI, 0.88–1.35; P = .43). The OMT treatment effects in chronic low back pain were also clinically relevant because they met or exceeded the Cochrane Back Review Group criterion for a medium effect size in all analyses for moderate to substantial improvements, including the sensitivity analyses (Table 2). Ultrasound therapy was not efficacious in any of these analyses.

Secondary Outcomes

Neither OMT nor UST yielded significant improvements in RMDQ or SF-36 GH scores (Table 3). Sham UST patients were less likely than UST patients and OMT patients were less likely than sham OMT patients to report work disability because of low back pain at weeks 4 and 8, respectively. Neither of these groups sustained significant improvements at week 12, however. The OMT patients were more likely than sham OMT patients to report being very satisfied with their back care at all endpoints (P <.001). A total of 31 (13%) OMT patients vs 46 (20%) sham OMT patients reported using prescription drugs for low back pain during the study (use ratio = 0.66; 95% CI, 0.43–1.00; P = .048). The statistical significance of this finding persisted after simultaneously controlling for all other co-treatments.

Safety Profiles

Only 1 patient developed a contraindication to continued participation that was adjudicated to be possibly related to OMT. This contraindication involved recurrent back spasticity following OMT. There were 27 (6%) patients with adverse events (Supplemental Figure 1). Nine (2%) patients had a serious adverse event, none of which was definitely or probably related to a study intervention. There were no significant differences between the main effects groups in the frequency of adverse events or serious adverse events.

Adequacy of Patient Blinding

All 6 treatments were attended by 191 (83%) OMT patients vs 191 (85%) sham OMT patients (adherence ratio = 0.98; 95% CI, 0.90–1.06; P = .59), and by 192 (82%) UST patients vs 190 (86%) sham UST patients (adherence ratio = 0.96; 95% CI, 0.89–1.04; P = .36). At week 12, sham OMT patients reported a median change score on the visual analog scale of −9 mm (IQR = −25 to 3 mm) vs −13 mm (IQR = −27 to 1 mm) reported by sham UST patients.

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