NCT07406711

Biopsychosocial vs Multimodal Chronic Pain Management

Randomized Controlled Trial on the Effectiveness of a Multidisciplinary Biopsychosocial Program vs Multimodal Treatment in Patients With Chronic Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Osijek University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effects of a multidisciplinary biopsychosocial program compared with standard multimodal care in patients with chronic low back pain treated at the University Hospital Osijek. Outcomes included pain intensity, disability, health-related quality of life, anxiety, depression, stress, and sleep quality. Data were collected using standardized self-assessment questionnaires and objective monitoring of sleep and physical activity during a four-week intervention period. The study was conducted as part of a doctoral dissertation.

Detailed description

This prospective, randomized, parallel-group study compared a multidisciplinary biopsychosocial treatment program with standard multimodal care in patients with chronic low back pain treated at the Department of Pain Management, University Hospital Osijek. Participants were randomly assigned to one of two treatment groups using a random number generator. The multidisciplinary biopsychosocial group participated in a structured four-week program that included patient education, supervised exercise, individualized multidisciplinary care, pharmacotherapy, and acupuncture. The standard multimodal care group received conservative treatment, including pharmacotherapy, physical therapy modalities, and acupuncture. Clinical and patient-reported outcomes were assessed using standardized self-report questionnaires measuring pain intensity, functional disability, health-related quality of life, anxiety, depression, stress, and sleep quality. In addition, objective data on sleep and physical activity were collected using a wearable smartwatch during the intervention period. The study was conducted between November 2021 and May 2023 as part of a doctoral dissertation.

Conditions

• Chronic Low Back Pain
• Multidisciplinary Biopsychosocial Program
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions.	Multidisciplinary Biopsychosocial Program A structured four-week multidisciplinary biopsychosocial treatment program combining patient education, supervised exercise, and individualized care delivered by a multidisciplinary healthcare team. The program addressed physical, psychological, and social aspects of chronic low back pain and included adjunct physical therapy modalities and acupuncture as part of routine clinical care. Participants continued their usual prescribed medications throughout the study.
OTHER	Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications.	Multimodal treatment consisting of physical therapy modalities provided according to standard clinical practice, and acupuncture. Treatment was individualized based on patient needs and did not include a structured multidisciplinary biopsychosocial program. Participants continued their usual prescribed medications throughout the study.

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-05-29
• Completion: 2023-05-29
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Croatia