Effectiveness of Digital Intelligence-Supported Real-Time Management in Adults With Chronic Pain: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in pain intensity measured at baseline, Week 2, and Week 4 using the Numeric Rating Scale (0-10).
研究概览
简要总结
This randomized controlled study will evaluate the effectiveness of real-time digital intelligence in the treatment of chronic pain. A total of 80 adult patients enrolled in a four-week multidisciplinary chronic pain programme will be randomly assigned to either standard treatment alone or standard treatment supported by a smartwatch and a mobile application for real-time monitoring of pain intensity, analgesic use, physical activity, and heart rate.
Both groups will complete validated questionnaires assessing pain intensity, disability, quality of life, sleep, anxiety, depression, and treatment satisfaction at baseline, two weeks, and four weeks. The intervention group will additionally record daily pain scores and medication use via a mobile application and wear a smartwatch for continuous activity and heart rate monitoring.
The study aims to determine whether real-time digital monitoring and physician availability improve clinical outcomes compared with standard multidisciplinary care alone.
详细描述
**Detailed Description**
This study is a prospective, randomized controlled trial designed to evaluate the added value of real-time digital intelligence in a structured, four-week multidisciplinary chronic pain programme.
Eligible adult patients with chronic pain who are enrolled in the programme will be randomly assigned (1:1) to either standard multidisciplinary treatment or standard treatment supplemented with digital monitoring tools. Randomisation will be performed using computer-generated allocation.
The control group will receive the usual four-week multidisciplinary intervention and complete validated outcome measures at baseline, week 2, and week 4. These measures will assess pain intensity, pain-related disability, quality of life, sleep quality, anxiety, depression, and treatment satisfaction.
The intervention group will receive the same multidisciplinary treatment and assessment schedule. In addition, participants will use a smartwatch to continuously monitor physical activity and heart rate and a mobile application to record daily pain intensity, timing of regular analgesic therapy, and use of rescue medication. Study questionnaires will also be completed through the mobile application. Physicians will have continuous access to patient-reported data during the study period.
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
Standard Multidisciplinary Treatment + Digital Monitoring
The intervention group will receive the same multidisciplinary treatment and assessment schedule. In addition, participants will use a smartwatch to continuously monitor physical activity and heart rate and a mobile application to record daily pain intensity, timing of regular analgesic therapy, and use of rescue medication. Study questionnaires will also be completed through the mobile application. Physicians will have continuous access to patient-reported data during the study period.
干预措施: tandard Treatment + Digital Monitoring (Intervention Group) (Behavioral)
Standard Multidisciplinary Treatment (Control Group)
The control group will receive the usual four-week multidisciplinary intervention and complete validated outcome measures at baseline, week 2, and week 4. These measures will assess pain intensity, pain-related disability, quality of life, sleep quality, anxiety, depression, and treatment satisfaction.
干预措施: Standard Multidisciplinary Treatment (Control Group) (Behavioral)
结局指标
主要结局
Change in pain intensity measured at baseline, Week 2, and Week 4 using the Numeric Rating Scale (0-10).
时间窗: aseline, Week 2, and Week 4
ain intensity is assessed at baseline, Week 2, and Week 4 using a self-reported 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain). The outcome represents the change in pain intensity over time, with greater reductions indicating clinical improvement.
次要结局
- Change in the SF-36 Physical Functioning domain score from baseline to Week 2 and Week 4.(baseline, Week 2, and Week 4)
- Change in the SF-36 Physical Limitations domain score over time, measured at baseline, Week 2, and Week 4.(baseline, Week 2, and Week 4)
- Change in the SF-36 Emotional Limitations domain score over time, measured at baseline, Week 2, and Week 4.(baseline, Week 2, and Week 4)
- Change in the SF-36 Energy and Vitality domain score over time, measured at baseline, Week 2, and Week 4(baseline, Week 2, and Week 4)
- Change in the SF-36 Psychological Health domain score over time, measured at baseline, Week 2, and Week 4.(baseline, Week 2, and Week 4)
- Change in the SF-36 Social Functioning domain score over time, measured at baseline, Week 2, and Week 4(baseline, Week 2, and Week 4)
- Change in the SF-36 Physical Pain domain score over time, measured at baseline, Week 2, and Week 4(baseline, Week 2, and Week 4)
- Change in the SF-36 General Health domain score from baseline to Week 2 and Week 4.(baseline, Week 2, and Week 4)
- Change in Oswestry Disability Index (ODI) 2.1a total score from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in Depression score measured by the Depression Anxiety Stress Scales-21 (DASS-21) from baseline to Week 2 and Week 4(baseline to Week 2 and Week 4)
- Change in Anxiety score measured by the Depression Anxiety Stress Scales-21 (DASS-21) from baseline to Week 2 and Week 4(baseline to Week 2 and Week 4)
- Change in Stress score measured by the Depression Anxiety Stress Scales-21 (DASS-21) from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in Subjective Sleep Quality score measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 2 and Week 4(baseline to Week 2 and Week 4)
- Change in Sleep Latency score measured by the PSQI from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4.)
- Change in Sleep Duration score measured by the PSQI from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in Habitual Sleep Efficiency score measured by the PSQI from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in Sleep Disturbances score measured by the PSQI from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4.)
- Change in Use of Sleeping Medication score measured by the PSQI from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in Daytime Dysfunction score measured by the PSQI from baseline to Week 2 and Week 4(baseline to Week 2 and Week 4)
- Physical activity (step count) measured by Apple Watch at baseline, Week 2, and Week 4(baseline, Week 2, and Week 4)
- Sleep quality (Sleep Score) measured by Apple Watch at baseline, Week 2, and Week 4(baseline, Week 2, and Week 4.)
- Change in PCS Rumination subscale score from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in PCS Magnification subscale score from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in PCS Helplessness subscale score from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in PCS total score from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in painDETECT questionnaire total score from baseline to Week 2 and Week 4(baseline, Week 2, and Week 4)
- Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A).(Baseline, Week 2, and Week 4.)
- Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D).(Baseline, Week 2, and Week 4.)
- Change in neck-related disability measured by the Neck Disability Index (NDI).(Baseline, Week 2, and Week 4.)
- Beliefs about the necessity of medication measured by the Beliefs about Medicines Questionnaire - Specific Necessity subscale (BMQ-Specific Necessity) at Baseline, Week 2, and Week 4.(Baseline, Week 2, and Week 4.)
- Concerns about medication measured by the Beliefs about Medicines Questionnaire - Specific Concerns subscale (BMQ-Specific Concerns) at Baseline, Week 2, and Week 4.(Baseline, Week 2, and Week 4.)
研究者
Ivan Radoš
Principal Investigator
Osijek University Hospital