Randomized Controlled Trial on the Effectiveness of a Multidisciplinary Biopsychosocial Program vs Multimodal Treatment in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in pain intensity from baseline to Day 28 measured by Numeric Rating Scale (0-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Chronic low back pain significantly affecting disability and/or emotional distress
- •Active use of Croatian language
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
Multidisciplinary Biopsychosocial Program
干预措施: Four-week program including group and individual therapy with a multidisciplinary team.Sessions included educational lectures, physical therapy, and multimodal interventions. (Behavioral)
Multimodal Treatment
干预措施: Multimodal treatment. Four-week program including: TENS; Therapeutic ultrasound; Magnetotherapy; Acupuncture. Participants continued their usual prescribed medications. (Other)
结局指标
主要结局
Change in pain intensity from baseline to Day 28 measured by Numeric Rating Scale (0-10)
时间窗: 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.
次要结局
- 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)
- Change in SF-36 Social Functioning domain score from baseline to Day 28(Baseline and Day 28)
- Change in SF-36 Physical Pain domain score from baseline to Day 28(Baseline and Day 28)
- Change in SF-36 General Health domain score from baseline to Day 28(Baseline and Day 28)
- Change in Oswestry Disability Index (ODI) 2.1a total score from baseline to Day 28(Baseline and Day 28)
- Change in Depression score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)(Baseline and Day 28)
- Change in Anxiety score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)(Baseline and Day 28)
- Change in Stress score from baseline to Day 28 measured by the Depression Anxiety Stress Scales-21 (DASS-21)(Baseline and Day 28)
- Change in Subjective Sleep Quality score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Day 28)
- Change in Sleep Latency score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Day 28)
- Change in Sleep Duration score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Day 28)
- Change in Habitual Sleep Efficiency score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Day 28)
- Change in Sleep Disturbances score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Day 28)
- Change in Use of Sleeping Medication score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Day 28)
- Change in Daytime Dysfunction score from baseline to Day 28 measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Day 28)
- Physical activity / step count measured by Fitbit Charge 3 during the 4-week treatment period(During the 4-week treatment period)
- Sleep quality (Sleep Score) measured by Fitbit Charge 3 during the 4-week treatment period(During the 4-week treatment period)
- Change in Pain Catastrophizing Scale (PCS) Rumination subscale score from baseline to Day 28(Baseline and Day 28)
- Change in Pain Catastrophizing Scale (PCS) Magnification subscale score from baseline to Day 28(Baseline and Day 28)
- Change in Pain Catastrophizing Scale (PCS) Helplessness subscale score from baseline to Day 28(Baseline and Day 28)
- Change in Pain Catastrophizing Scale (PCS) total score from baseline to Day 28(Baseline and Day 28)
- Change in painDETECT questionnaire total score from baseline to Day 28(Baseline and Day 28)
研究者
Dijana Hnatesen
Principal Investigator
Osijek University Hospital