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Completed

NCT Number: NCT07406711

Biopsychosocial vs Multimodal Chronic Pain Management

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.

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Key information

Conditions

Chronic Low Back Pain Multidisciplinary Biopsychosocial Program Quality of Life

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Osijek

Osijek, 31000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline and Day 28

    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.

Secondary outcomes

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

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the Physical Functioning domain score (range 0-100, higher scores indicate better functioning) from baseline to Day 28, with greater increases indicating improvement.

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

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the Physical Limitations domain score (range 0-100, higher scores indicate fewer physical limitations) from baseline to Day 28, with greater increases indicating improvement.

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

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the Emotional Limitations domain score (range 0-100, higher scores indicate fewer emotional limitations) from baseline to Day 28, with greater increases indicating improvement.

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

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the Energy and Vitality domain score (range 0-100, higher scores indicate greater energy and vitality) from baseline to Day 28, with greater increases indicating improvement.

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

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the Psychological Health domain score (range 0-100, higher scores indicate better psychological well-being) from baseline to Day 28, with greater increases indicating improvement.

  6. Change in SF-36 Social Functioning domain score from baseline to Day 28

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the Social Functioning domain score (range 0-100, higher scores indicate better social functioning) from baseline to Day 28, with greater increases indicating improvement.

  7. Change in SF-36 Physical Pain domain score from baseline to Day 28

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the Physical Pain domain score (range 0-100, higher scores indicate less pain) from baseline to Day 28, with greater increases indicating improvement.

  8. Change in SF-36 General Health domain score from baseline to Day 28

    Time frame: Baseline and Day 28

    Health-related quality of life is assessed using the Croatian-validated Short Form-36 questionnaire.

    The outcome represents the change in the General Health domain score (range 0-100, higher scores indicate better perceived health) from baseline to Day 28, with greater increases indicating improvement.

  9. Change in Oswestry Disability Index (ODI) 2.1a total score from baseline to Day 28

    Time frame: Baseline and Day 28

    Disability related to low back pain is assessed using the Croatian-validated version of the Oswestry Disability Index (ODI) 2.1a questionnaire.

    The outcome represents the change in the total ODI score (range 0-100, higher scores indicate greater disability) from baseline to Day 28, with greater decreases indicating improvement.

  10. Change in Depression score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)

    Time frame: Baseline and Day 28

    Symptoms of depression are assessed using the Croatian-validated version of the Depression Anxiety Stress Scales-21 (DASS-21).

    The outcome represents the change in the Depression subscale score (higher scores indicate more severe depressive symptoms) from baseline to Day 28, with greater decreases indicating improvement.

  11. Change in Anxiety score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)

    Time frame: Baseline and Day 28

    Symptoms of anxiety are assessed using the Croatian-validated version of the Depression Anxiety Stress Scales-21 (DASS-21).

    The outcome represents the change in the Anxiety subscale score (higher scores indicate more severe anxiety symptoms) from baseline to Day 28, with greater decreases indicating improvement.

  12. Change in Stress score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)

    Time frame: Baseline and Day 28

    Stress symptoms are assessed using the Croatian-validated version of the Depression Anxiety Stress Scales-21 (DASS-21).

    The outcome represents the change in the Stress subscale score (higher scores indicate more severe stress symptoms) from baseline to Day 28, with greater decreases indicating improvement.

  13. Change in Subjective Sleep Quality score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Day 28

    Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The outcome represents the change in the Subjective Sleep Quality component score (higher scores indicate worse sleep quality) from baseline to Day 28, with greater decreases indicating improvement.

  14. Change in Sleep Latency score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Day 28

    Sleep latency is assessed using the PSQI. The outcome represents the change in the Sleep Latency component score (higher scores indicate longer time to fall asleep and worse sleep) from baseline to Day 28, with greater decreases indicating improvement.

  15. Change in Sleep Duration score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Day 28

    Sleep duration is assessed using the PSQI. The outcome represents the change in the Sleep Duration component score (higher scores indicate shorter sleep duration and worse sleep) from baseline to Day 28, with greater decreases indicating improvement.

  16. Change in Habitual Sleep Efficiency score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Day 28

    Habitual Sleep Efficiency is assessed using the PSQI. The outcome represents the change in the Habitual Sleep Efficiency component score (higher scores indicate lower sleep efficiency and worse sleep) from baseline to Day 28, with greater decreases indicating improvement.

  17. Change in Sleep Disturbances score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Day 28

    Sleep Disturbances are assessed using the PSQI. The outcome represents the change in the Sleep Disturbances component score (higher scores indicate more frequent disturbances and worse sleep) from baseline to Day 28, with greater decreases indicating improvement.

  18. Change in Use of Sleeping Medication score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Day 28

    Use of Sleeping Medication is assessed using the PSQI. The outcome represents the change in the Use of Sleeping Medication component score (higher scores indicate more frequent medication use) from baseline to Day 28, with greater decreases indicating improvement.

  19. Change in Daytime Dysfunction score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and Day 28

    Daytime Dysfunction is assessed using the PSQI. The outcome represents the change in the Daytime Dysfunction component score (higher scores indicate greater daytime impairment) from baseline to Day 28, with greater decreases indicating improvement.

  20. Physical activity / step count measured by Fitbit Charge 3 during the 4-week treatment period

    Time frame: During the 4-week treatment period

    Physical activity / step count is measured using the Fitbit Charge 3 wearable device.

    The outcome represents physical activity / step count summarized across the 4-week treatment period, with higher values indicating greater physical activity.

  21. Sleep quality (Sleep Score) measured by Fitbit Charge 3 during the 4-week treatment period

    Time frame: During the 4-week treatment period

    Sleep quality (Sleep Score) is measured using the Sleep Score generated from sleep stage tracking recorded by the Fitbit Charge 3 wearable device.

    The outcome represents the Sleep Score summarized across the 4-week treatment period, with higher scores indicating better sleep quality.

  22. Change in Pain Catastrophizing Scale (PCS) Rumination subscale score from baseline to Day 28

    Time frame: Baseline and Day 28

    Pain rumination is assessed using the Rumination subscale of the Pain Catastrophizing Scale (PCS), a validated self-report questionnaire measuring repetitive negative focus on pain.

    The outcome represents the change in the PCS Rumination subscale score from baseline to Day 28, with higher scores indicating greater rumination and greater decreases indicating improvement.

  23. Change in Pain Catastrophizing Scale (PCS) Magnification subscale score from baseline to Day 28

    Time frame: Baseline and Day 28

    Change in Pain Catastrophizing Scale (PCS) Magnification subscale score from baseline to Day 28

  24. Change in Pain Catastrophizing Scale (PCS) Helplessness subscale score from baseline to Day 28

    Time frame: Baseline and Day 28

    Pain-related helplessness is assessed using the Helplessness subscale of the Pain Catastrophizing Scale (PCS), a validated self-report questionnaire measuring perceived inability to cope with pain.

    The outcome represents the change in the PCS Helplessness subscale score from baseline to Day 28, with higher scores indicating greater helplessness and greater decreases indicating improvement.

  25. Change in Pain Catastrophizing Scale (PCS) total score from baseline to Day 28

    Time frame: Baseline and Day 28

    Pain catastrophizing is assessed using the total score of the Pain Catastrophizing Scale (PCS), a validated self-report questionnaire measuring rumination, magnification, and helplessness related to pain.

    The outcome represents the change in the PCS total score from baseline to Day 28, with higher scores indicating greater pain catastrophizing and greater decreases indicating improvement.

  26. Change in painDETECT questionnaire total score from baseline to Day 28

    Time frame: Baseline and Day 28

    Neuropathic pain features are assessed using the painDETECT questionnaire, a validated self-report screening instrument designed to identify neuropathic pain components. The outcome represents the change in the painDETECT total score from baseline to Day 28, with higher scores indicating a greater likelihood of neuropathic pain and greater decreases indicating improvement.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Collaborators

  • Josip Juraj Strossmayer University of Osijek

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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