Osteopathic manipulative treatment, pain neuroscience education and clinical hypnosis as pain management interventions in chronic low back pain: a randomized sham-controlled feasibility pilot trial.

BACKGROUND

Interventions for chronic low back pain (CLBP), such as pain neuroscience education (PNE), clinical hypnosis (CH), and osteopathic manipulative treatment (OMT), encounter barriers due to their subjective nature, which hinders their implementation in clinical practice.

AIM: To evaluate the implementation effectiveness of association of PNE, CH and OMT on pain and disability in low back pain patients compared to PNE, CH, and sham therapy.

METHODS

37 patients were randomized into two groups: G1 - PNE and CH associated with OMT (n = 19); and G2 - PNE and CH but associated with a simulated therapy (n = 18). All groups underwent four 50-min sessions (7-day intervals). Primary outcomes were pain intensity and disability. All patients were evaluated before treatment, after the last session and 4 weeks from the end of the procedures (follow-up). Linear mixed models with repeated-measures analysis and random effect models were used to assess between-group differences.

RESULTS

A significant reduction in pain was observed at both time points and in both groups. The intra-group pain improvement effect was Very Large in both groups (OMT d = 4.80; SHAM d =2.18). However, the OMT group maintained significantly lower pain values at follow-up (p = 0.001). Furthermore, only the OMT group showed a Very Large perception of improvement (d= 1.67) at both points (p = 0.005). Regarding disability, both groups improved (Very large for OMT, d = 1.89), but a significantly higher number of OMT group reported minimal disability after treatment (p = 0.009).

CONCLUSION

The protocol effectively improved pain, perception of improvement, and disability in patients treated with OMT, PNE, and CH, with PNE and CH also reducing pain and enhancing subjective perceptions.