Biopsychosocial vs Multimodal Chronic Pain Management

NCT07406711 | Completed

• 1 other identifier: EC-HOSP-R1-14812-2-2021
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

chronic low back pain; Multidisciplinary Biopsychosocial Program; Multimodal Treatment; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity from baseline to Day 28 measured by Numeric Rating Scale (0-10)

  Pain intensity is assessed using a self-reported 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). The outcome represents the change in pain intensity from baseline to Day 28, with greater reductions indicating improvement.

  Baseline and Day 28

Secondary Outcomes (26)

• Change in SF-36 Physical Functioning domain score from baseline to Day 28

  Baseline and Day 28

• Change in SF-36 Physical Limitations domain score from baseline to Day 28

  Baseline and Day 28

• Change in SF-36 Emotional Limitations domain score from baseline to Day 28

  Baseline and Day 28

• Change in SF-36 Energy and Vitality domain score from baseline to Day 28

  Baseline and Day 28

• Change in SF-36 Psychological Health domain score from baseline to Day 28

  Baseline and Day 28

Study Arms (2)

Multidisciplinary Biopsychosocial Program

EXPERIMENTAL

Behavioral: Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions.

Multimodal Treatment

ACTIVE COMPARATOR

Other: Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications.

Interventions

Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions. BEHAVIORAL

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.

Multidisciplinary Biopsychosocial Program

Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications. OTHER

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.

Multimodal Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Chronic low back pain significantly affecting disability and/or emotional distress
• Active use of Croatian language
• Signed informed consent

You may not qualify if:

• Age \<18 or \>65
• Acute pain
• Previous participation in multidisciplinary program
• Pregnancy or cancer-related pain
• Psychotic disorders, moderate-severe cognitive impairment, urgent psychiatric conditions
• PTSD symptoms, extreme fatigue, low motivation, low literacy
• Allergic reactions to metal or silicone

Sponsors & Collaborators

• Osijek University Hospital: lead
• Josip Juraj Strossmayer University of Osijek: collaborator

Study Sites (1)

University Hospital Osijek

Osijek, 31000, Croatia

Location

Related Publications (11)

• Sampaio R, Azevedo LF, Dias CC, Castro Lopes JM. Non-Adherence to Pharmacotherapy: A Prospective Multicentre Study About Its Incidence and Its Causes Perceived by Chronic Pain Patients. Patient Prefer Adherence. 2020 Feb 19;14:321-332. doi: 10.2147/PPA.S232577. eCollection 2020.

  PMID: 32109998 BACKGROUND

• Tagliaferri SD, Miller CT, Owen PJ, Mitchell UH, Brisby H, Fitzgibbon B, Masse-Alarie H, Van Oosterwijck J, Belavy DL. Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective. Pain Pract. 2020 Feb;20(2):211-225. doi: 10.1111/papr.12846. Epub 2019 Nov 11.

  PMID: 31610090 BACKGROUND

• Skarpsno ES, Mork PJ, Nilsen TIL, Nordstoga AL. Influence of sleep problems and co-occurring musculoskeletal pain on long-term prognosis of chronic low back pain: the HUNT Study. J Epidemiol Community Health. 2020 Mar;74(3):283-289. doi: 10.1136/jech-2019-212734. Epub 2019 Dec 4.

  PMID: 31801790 BACKGROUND

• Sirbu E, Onofrei RR, Szasz S, Susan M. Predictors of disability in patients with chronic low back pain. Arch Med Sci. 2020 Jul 8;19(1):94-100. doi: 10.5114/aoms.2020.97057. eCollection 2023.

  PMID: 36817655 BACKGROUND

• Hnatesen D, Pavic R, Rados I, Dimitrijevic I, Budrovac D, Cebohin M, Gusar I. Quality of Life and Mental Distress in Patients with Chronic Low Back Pain: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Aug 26;19(17):10657. doi: 10.3390/ijerph191710657.

  PMID: 36078372 BACKGROUND

• Vartiainen P, Heiskanen T, Sintonen H, Roine RP, Kalso E. Health-related quality of life change in patients treated at a multidisciplinary pain clinic. Eur J Pain. 2019 Aug;23(7):1318-1328. doi: 10.1002/ejp.1398. Epub 2019 May 3.

  PMID: 30980782 BACKGROUND

• Rivano Fischer M, Persson EB, Stalnacke BM, Schult ML, Lofgren M. Return to work after interdisciplinary pain rehabilitation: One- and two-year follow-up based on the Swedish Quality Registry for Pain rehabilitation. J Rehabil Med. 2019 Apr 1;51(4):281-289. doi: 10.2340/16501977-2544.

  PMID: 30847496 BACKGROUND

• Zhang Q, Jiang S, Young L, Li F. The Effectiveness of Group-Based Physiotherapy-Led Behavioral Psychological Interventions on Adults With Chronic Low Back Pain: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2019 Mar;98(3):215-225. doi: 10.1097/PHM.0000000000001053.

  PMID: 30277912 BACKGROUND

• Nielsen A, Dusek JA, Taylor-Swanson L, Tick H. Acupuncture Therapy as an Evidence-Based Nonpharmacologic Strategy for Comprehensive Acute Pain Care: The Academic Consortium Pain Task Force White Paper Update. Pain Med. 2022 Aug 31;23(9):1582-1612. doi: 10.1093/pm/pnac056.

  PMID: 35380733 BACKGROUND

• GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun.

  PMID: 37273833 BACKGROUND

• Brennan F, Lohman D, Gwyther L. Access to Pain Management as a Human Right. Am J Public Health. 2019 Jan;109(1):61-65. doi: 10.2105/AJPH.2018.304743.

  PMID: 32941757 BACKGROUND

MeSH Terms

Interventions

Physical Therapy Modalities; Combined Modality Therapy; Ultrasonic Therapy; Magnetic Field Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Diathermy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 12, 2026
• Study Start: November 15, 2021
• Primary Completion: May 29, 2023
• Study Completion: May 29, 2023
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)