Real-time Treatment of Chronic Pain Using Digital Intelligence

Официальное название

Effectiveness of Digital Intelligence-Supported Real-Time Management in Adults With Chronic Pain: A Randomised Controlled Trial

Обзор

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.

Подробное описание

\*\*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.

The primary objective is to determine whether real-time digital monitoring improves clinical outcomes compared with standard multidisciplinary care alone. Secondary objectives include evaluating patient engagement, feasibility of implementation, and satisfaction with digitally supported pain management.

Exclusion criteria include refusal to participate and inability to use a smartphone.

Вмешательства

• Поведенческое tandard Treatment + Digital Monitoring (Intervention Group)
  The intervention group will receive the same multidisciplinary treatment and assessment schedule. Participants will use a smartwatch to continuously monitor physical activity and heart rate
• Поведенческое 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.

Первичные конечные точки

• Change in pain intensity measured at baseline, Week 2, and Week 4 using the Numeric Rating Scale (0-10). [Срок оценки: aseline, Week 2, and Week 4]

Вторичные конечные точки (12)

• Change in the SF-36 Physical Functioning domain score from baseline to Week 2 and Week 4. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: baseline, Week 2, and Week 4]
• Change in the SF-36 General Health domain score from baseline to Week 2 and Week 4. [Срок оценки: baseline, Week 2, and Week 4]
• Change in Oswestry Disability Index (ODI) 2.1a total score from baseline to Week 2 and Week 4 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: baseline, Week 2, and Week 4]

Критерии участия

Критерии включения

• Age 18-65 years Chronic low back pain significantly affecting disability and/or emotional distress

• Active use of Croatian language
• Signed informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Хорватия · 1 центр

• Clinical Hospital Center Osijek — Osijek

Публикации

• Wijnen J, Geijselaers MWH, Pont ML, Van't Hullenaar G, Van Oosterwijck J, de Jong J. An Interdisciplinary Multimodal Integrative Healthcare Program for Chronic Spinal Pain and Comorbid Mental Disorders. Psychosom Med. 2024 Sep 1;86(7):603-614. doi: 10.1097/PSY.0000000000001316. Epub 2024 May 1. PMID 38718168
• Chowdhury AR, Schofield D, Shrestha R, Nicholas M. Economic analysis of patient-related effects of an interdisciplinary pain self-management program. Pain. 2023 Nov 1;164(11):2491-2500. doi: 10.1097/j.pain.0000000000002959. Epub 2023 Jun 15. PMID 37326690
• Schumann ME, Coombes BJ, Gascho KE, Geske JR, McDermott MC, Morrison EJ, Reynolds AL, Bernau JL, Gilliam WP. Pain Catastrophizing and Pain Self-Efficacy Mediate Interdisciplinary Pain Rehabilitation Program Outcomes at Posttreatment and Follow-Up. Pain Med. 2022 Apr 8;23(4):697-706. doi: 10.1093/pm/pnab271. PMID 34519826
• Dale R, Stacey B. Multimodal Treatment of Chronic Pain. Med Clin North Am. 2016 Jan;100(1):55-64. doi: 10.1016/j.mcna.2015.08.012. Epub 2015 Oct 17. PMID 26614719

Идентификаторы

NCT: NCT07454811 · EC-MSOsijek602-04/25-08/07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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