Efficacy of theta binaural beat stimulation plus music medicine in chronic low back pain: Preliminary findings from a randomized controlled trial

Abstract

Background: Binaural beat (BB) stimulation, particularly in the theta frequency range, has been proposed to reduce pain through auditory brainwave entrainment. This study evaluated the effects of combining theta-frequency BB with music medicine (MM) in individuals with chronic low back pain (CLBP), compared with MM alone and treatment as usual (TAU).

Methods: In this multicenter, three-arm randomized controlled trial, 84 adults with CLBP were randomized to MM (n = 29), MM plus binaural beats (MM-BB; n = 27), or TAU (n = 28). Participants in the MM and MM-BB groups listened to 20-minute audio recordings daily for two weeks. Outcomes were assessed at baseline and at 2 and 4 weeks. The primary outcome was change in average pain intensity at 2 weeks. Secondary outcomes included worst pain intensity, physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, global impression of change, treatment satisfaction, and medication use.

Results: At 2 weeks, both MM and MM-BB groups reported significantly greater reductions in average pain intensity than the TAU group (1.27 ± 1.09 and 1.59 ± 1.28 vs. 0.35 ± 1.34; P < 0.01), with effect sizes (Cohen’s d) of 0.75 and 0.95, respectively. The difference between MM-BB and MM was not statistically significant (d = 0.29). At 4 weeks, only the MM-BB group maintained significantly greater improvement in average pain compared with TAU and also demonstrated higher rates of improvement in depression, fatigue, social role participation, global change, and treatment satisfaction.

Conclusions: Both MM and MM-BB were associated with short-term reductions in pain intensity in CLBP. BB-enhanced MM demonstrated a pattern of more sustained benefits, warranting confirmation in larger and longer-term studies.