Chronic Low Back PainNCT07406711
Biopsychosocial vs Multimodal Chronic Pain Management
A study testing Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions. and Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications. in people with Chronic Low Back Pain and Multidisciplinary Biopsychosocial Program, run by Osijek University Hospital at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain, Multidisciplinary Biopsychosocial Program, Quality of Life
- What is being tested?
- Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions. and Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Nov 2021to 29 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Chronic low back pain significantly affecting disability and/or emotional distress
- Active use of Croatian language
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on the Effectiveness of a Multidisciplinary Biopsychosocial Program vs Multimodal Treatment in Patients With Chronic Low Back Pain
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.
Read the 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.
- Being tested
- Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions., Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications.
- Keywords
- chronic low back pain, Multidisciplinary Biopsychosocial Program, Multimodal Treatment, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Biopsychosocial Program | Experimental | Not described Receives: 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 | Not described Receives: Other: Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 28
Secondary outcomes (26)
Change in SF-36 Physical Functioning domain score from baseline to 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.
Measured: Baseline and Day 28
Change in SF-36 Physical Limitations domain score from baseline to 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.
Measured: Baseline and Day 28
Change in SF-36 Emotional Limitations domain score from baseline to 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.
Measured: Baseline and Day 28
Change in SF-36 Energy and Vitality domain score from baseline to 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.
Measured: Baseline and Day 28
Change in SF-36 Psychological Health domain score from baseline to 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.
Measured: Baseline and Day 28
Change in SF-36 Social Functioning domain score from baseline to 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.
Measured: Baseline and Day 28
Change in SF-36 Physical Pain domain score from baseline to 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.
Measured: Baseline and Day 28
Change in SF-36 General Health domain score from baseline to 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.
Measured: Baseline and Day 28
Change in Oswestry Disability Index (ODI) 2.1a total score from baseline to 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.
Measured: Baseline and Day 28
Change in Depression score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)
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.
Measured: Baseline and Day 28
Change in Anxiety score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)
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.
Measured: Baseline and Day 28
Change in Stress score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)
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.
Measured: Baseline and Day 28
Change in Subjective Sleep Quality score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and Day 28
Change in Sleep Latency score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and Day 28
Change in Sleep Duration score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and Day 28
Change in Habitual Sleep Efficiency score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and Day 28
Change in Sleep Disturbances score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and Day 28
Change in Use of Sleeping Medication score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and Day 28
Change in Daytime Dysfunction score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and Day 28
Physical activity / step count measured by Fitbit Charge 3 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.
Measured: During the 4-week treatment period
Sleep quality (Sleep Score) measured by Fitbit Charge 3 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.
Measured: During the 4-week treatment period
Change in Pain Catastrophizing Scale (PCS) Rumination subscale score from baseline to 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.
Measured: Baseline and Day 28
Change in Pain Catastrophizing Scale (PCS) Magnification subscale score from baseline to Day 28
Change in Pain Catastrophizing Scale (PCS) Magnification subscale score from baseline to Day 28
Measured: Baseline and Day 28
Change in Pain Catastrophizing Scale (PCS) Helplessness subscale score from baseline to 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.
Measured: Baseline and Day 28
Change in Pain Catastrophizing Scale (PCS) total score from baseline to 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.
Measured: Baseline and Day 28
Change in painDETECT questionnaire total score from baseline to 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.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start15 Nov 2021
- Primary completion29 May 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Responsible party
- Principal investigator, Dijana Hnatesen, Osijek University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406711
- Sponsor's protocol ID
- EC-HOSP-R1-14812-2-2021
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32109998Tagliaferri 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.
PubMed 31610090Skarpsno 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.
PubMed 31801790Sirbu 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.
PubMed 36817655Hnatesen 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.
PubMed 36078372Vartiainen 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.
PubMed 30980782Rivano 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.
PubMed 30847496Zhang 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.
PubMed 30277912Nielsen 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.
PubMed 35380733GBD 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.
PubMed 37273833Brennan 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.
PubMed 32941757
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effectiveness of a Multidisciplinary Biopsychosocial Program vs Multimodal Treatment in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07406711
- Acronym / sponsor ID
- EC-HOSP-R1-14812-2-2021
- Keywords
- chronic low back pain, Multidisciplinary Biopsychosocial Program, Multimodal Treatment, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Chronic low back pain significantly affecting disability and/or emotional distress
- Active use of Croatian language
- Signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Multidisciplinary Biopsychosocial Program |
| 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. | Other | Multimodal Treatment |
Primary outcome
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.
26 secondary outcomes
Change in SF-36 Physical Functioning domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in SF-36 Physical Limitations domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in SF-36 Emotional Limitations domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in SF-36 Energy and Vitality domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in SF-36 Psychological Health domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in SF-36 Social Functioning domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in SF-36 Physical Pain domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in SF-36 General Health domain score from baseline to Day 28
Time frame: Baseline and Day 28
Change in Oswestry Disability Index (ODI) 2.1a total score from baseline to Day 28
Time frame: Baseline and Day 28
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
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
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
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
Change in Sleep Latency score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Day 28
Change in Sleep Duration score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Day 28
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
Change in Sleep Disturbances score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Day 28
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
Change in Daytime Dysfunction score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Day 28
Physical activity / step count measured by Fitbit Charge 3 during the 4-week treatment period
Time frame: During the 4-week treatment period
Sleep quality (Sleep Score) measured by Fitbit Charge 3 during the 4-week treatment period
Time frame: During the 4-week treatment period
Change in Pain Catastrophizing Scale (PCS) Rumination 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
Time frame: Baseline and Day 28
Change in Pain Catastrophizing Scale (PCS) Helplessness subscale score from baseline to Day 28
Time frame: Baseline and Day 28
Change in Pain Catastrophizing Scale (PCS) total score from baseline to Day 28
Time frame: Baseline and Day 28
Change in painDETECT questionnaire total score from baseline to Day 28
Time frame: Baseline and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 32109998Sampaio 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.
- Background: PubMed 31610090Tagliaferri 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.
- Background: PubMed 31801790Skarpsno 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.
- Background: PubMed 36817655Sirbu 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.
- Background: PubMed 36078372Hnatesen 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.
- Background: PubMed 30980782Vartiainen 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.
- Background: PubMed 30847496Rivano 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.
- Background: PubMed 30277912Zhang 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.
- Background: PubMed 35380733Nielsen 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.
- Background: PubMed 37273833GBD 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.
- Background: PubMed 32941757Brennan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions. and Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications. in people with Chronic Low Back Pain and Multidisciplinary Biopsychosocial Program, run by Osijek University Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity from baseline to Day 28 measured by Numeric Rating Scale (0-10) (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07406711, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.