The effect of an adjunct psychosomatic intervention on perceived pain in patients with musculoskeletal disorders: protocol for a randomized controlled trial

Trials. 2026 Mar 5. doi: 10.1186/s13063-026-09593-8. Online ahead of print.

ABSTRACT

BACKGROUND: Musculoskeletal disorders, including chronic back pain, osteoarthritis, rheumatoid arthritis, and fibromyalgia, are leading causes of chronic pain and reduced quality of life. Standard treatment approaches often focus on physical symptoms, while psychosomatic factors are sometimes overlooked. This study aims to evaluate the effectiveness of adjunct psychosomatic interventions-guided meditation and aromatherapy-on pain perception, stress levels, and quality of life in patients with musculoskeletal disorders.

METHODS: This is a three-arm, prospective, randomized controlled trial conducted in Germany. A total of 90 participants aged 18 to 90 with chronic musculoskeletal disorders will be randomized into one of three groups: (1) guided meditation, (2) aromatherapy, or (3) control receiving standard care. The intervention groups will receive either body-scan meditation (23 min, twice weekly) or aromatherapy (5-10 min daily) for one week. The primary outcomes include pain intensity (measured using the Numerical Rating Scale), perceived stress (measured using the Perceived Stress Questionnaire), and quality of life (measured using the EQ-5D). Secondary outcomes will include pain medication consumption. Follow-up assessments will be conducted at 3-, 6-, and 12-month post-intervention. Data will be analyzed using an intention-to-treat approach with ANCOVA for primary endpoints.

DISCUSSION: This trial will provide valuable insights into the effectiveness of psychosomatic interventions as adjunct therapies for managing chronic pain and stress in musculoskeletal disorders. If successful, these interventions could be implemented as cost-effective and non-invasive strategies to improve quality of life and pain management for patients with musculoskeletal conditions. The findings may also inform future studies on integrative treatment approaches for chronic pain conditions.

TRIAL REGISTRATION: The trial is registered at the German Clinical Trials Register (https://www.drks.de), registration number DRKS00034506.

PMID:41787463 | DOI:10.1186/s13063-026-09593-8