Effects of acupuncture and mindfulness-based stress reduction for chronic non-specific low back pain: study protocol for a 2×2 factorial randomised controlled trial.

Researchers in China are launching a study to test whether combining acupuncture with mindfulness meditation works better for chronic low back pain than either treatment alone. Chronic non-specific low back pain is a complex condition that affects both the body and mind, making it difficult to treat with a single approach. This study will involve 120 people with chronic low back pain who will be randomly assigned to one of four groups: acupuncture only, mindfulness-based stress reduction (MBSR) only, both treatments combined, or health education as a comparison. The treatments will last 6 weeks, and participants will be evaluated at the start, after 6 weeks, and again at 4 months. Researchers will measure pain levels, physical function, sleep quality, anxiety, depression, and mindfulness skills using various questionnaires and tests. Both acupuncture and mindfulness meditation have been recommended by medical guidelines and shown to help with chronic low back pain individually, but no one has studied whether using them together provides additional benefits. This research is important because it could help identify the most effective treatment approach for people whose back pain has both physical and emotional components. The results will help doctors and patients make better decisions about combining different non-drug therapies. If you're considering acupuncture for chronic low back pain, seek treatment from a licensed acupuncturist with experience in pain management.

This protocol describes a 2×2 factorial randomized controlled trial examining synergistic effects of acupuncture combined with mindfulness-based stress reduction (MBSR) for chronic non-specific low back pain (CNLBP). The study will recruit 120 participants randomized to four arms: acupuncture alone, MBSR alone, combined acupuncture plus MBSR, or health education control. The 6-week intervention will assess outcomes using validated instruments including VAS, SF-MPQ, RMDQ, ODI, FFMQ, DASS-21, BDI-II, BAI, FABQ, PCS, PSQ, and PSQI. Measurements occur at baseline, 6 weeks, and 4-month follow-up. This factorial design will enable evaluation of individual and combined treatment effects, as well as potential interaction effects between acupuncture and MBSR. The study addresses a clinical gap, as both interventions are guideline-recommended but their combination remains unexplored. Results will inform evidence-based integration of mind-body therapies for CNLBP patients presenting with both physical dysfunction and psychological distress. Trial registration: ITMCTR2025000764.