Pre-habilitation Interventions to Empower Patients With Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Non-Cancer Pain

• Registration Number: NCT05178082
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The development of alternative methods to address simple clinical needs and easy interventions of self-application are desired in the pre-habilitation period (waiting list). To our knowledge that are very few studies regarding interventions for patients in waiting list for specialized treatment of chronic non-cancer pain (CNCP) and they do not include cognitive-behavioural programs. This project is based on the hypothesis that educational and cognitive-behavioural interventions help to reduce deleterious effects of pain on some areas of patient's life. Therefore, the goal is to test two different interventions to help patients to self-manage their pain and avoid worsening in the pre-clinical period.

Detailed Description

It is a randomized controlled trial for application and assessment of two interventions: an educational Video-based Pain Program (VP) and Empowered Relief Program (ER). The primary purpose of our study is to investigate the effect of ER and VP on the Pain Catastrophizing Score in people with CNCP who are waiting for Multidisciplinary pain treatment. The secondary aim is to analyse the effects on other patient reported outcomes such as pain intensity, pain interference in daily activities, pain catastrophizing, pain acceptance, quality of life, mood, perceived change on over-all pain status, as well as consumption of pain medicine and usage of healthcare services. The effects of the two interventions will be compared with each other and a control group.

Study Timeline

• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-05
• Study Start: 2023-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• First appointment date at the Multidisciplinary Pain Centre scheduled at least three months after the invitation to participate in this study
• At least 18 years old
• Fluent in the Danish language
• Access to internet
• Willing and available to participate in the study

Exclusion Criteria

• History of cognitive dysfunction that interfere with understanding of the educational program and answering the questionnaires
• Epilepsy
• Current history of severe depression
• Current use of private pain services

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change from baseline pain catastrophizing at 2, 6 and 12 months	Baseline, 2 months, 6 months, and 12 months after the intervention	Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score

Secondary Outcome Measures

Name	Time	Method
Change from baseline health status at 2, 6 and 12 months	Baseline, 2 months, 6 months, and 12 months after the intervention	The Measure Yourself Medical Outcome Profile (MYMOP 2), which measures effects on patient self generated outcome on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing.
Change from baseline pain intensity and interference in daily activities at 2, 6 and 12 months	Baseline, 2 months, 6 months, and 12 months after the intervention	Brief Pain Inventory to measure pain intensity and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life with other.
Change from baseline pain acceptance at 2, 6 and 12 months	Baseline, 2 months, 6 months, and 12 months after the intervention	Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score.
Change from baseline health-related quality of life at 2, 6 and 12 months	Baseline, 2 months, 6 months, and 12 months after the intervention	RAND 36-Item Short Form Health Survey version 1.0 to assess physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.
Change from baseline depression at 2, 6 and 12 months	Baseline, 2 months, 6 months, and 12 months after the intervention	Patient Health Questionnaires scale (PHQ-9) can help track a patient's overall depression severity as well as track the improvement of specific symptoms with treatment.
Change from baseline anxiety at 2, 6 and 12 months	Baseline, 2 months, 6 months, and 12 months after the intervention	General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity.
Use of medication and health care system at 2, 6 and 12 months	2 months, 6 months, and 12 months after the intervention	Medication used (type and quantity), the number of times that he/she used the health care system because of chronic pain problem and treatment received (pharmacologic, surgical, rehabilitation, etc.), and number of absent days at work because of pain.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 København, København Ø., Denmark