Transcutaneous Electrical Nerve Stimulation vs Transcutaneous Electrical Nerve Stimulation With Music in Persistent Low-Back Pain: Protocol for a Pilot Feasibility Trial.

Background: Transcutaneous electrical nerve stimulation (TENS) works on the principle of the gate control theory of pain and is used as a nonpharmacological pain management intervention. Music therapy or listening to self-selected music has also been shown to reduce pain intensity, anxiety, and depression. There has been no published literature that has explored whether these modalities can work synergistically. Objective: This study aims to test the feasibility of a clinical trial comparing TENS alone to TENS combined with self-selected music in participants with persistent low-back pain lasting more than 3 months. Methods: This will be a prospective, randomized controlled pilot study to compare TENS alone vs TENS combined with participant self-selected music. We hope to enroll 20 participants. The participants will be their own controls, and the order in which the intervention is delivered will be determined by randomization. Results: The study is open for recruitment from August 2025. The results are expected in 18 months from the start of recruitment. The primary outcome will be the feasibility of the intervention, monitored by adherence rate, dropout rate, and the percentage of the eligible population that consented. Secondary outcomes collected will include pain intensity; mood using the 21-item Depression, Anxiety, and Stress Scale; medication consumption; participant satisfaction; and adverse reactions. Conclusions: If the pilot trial is feasible and indicates a positive synergistic trend with TENS and music, the trial will help to inform the feasibility for a larger trial with more varied pain diagnoses, including acute and chronic pain.