Clinical trial NCT05178082: Pre-habilitation Interventions to Empower Patients With Chronic Pain
Official title: Pre-habilitation Interventions to Empower Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Non-Cancer Pain
Keywords: Chronic non-cancer pain
Cognitive-behavioral program
Waiting list
Pain catastrophizing
Patient Reported Outcomes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
First posted: 2022-01-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized controlled trial for application and assessment of the two interventions. Patients waiting for multidisciplinary pain treatment at Rigshospitalet and Herlev/Gentofte Hospital will be invited to participate and randomly assigned to one of three arms (1:1:1): VP group, ER group or control group (no intervention). Assessments will occur at baseline, 2 months, 6 months, and 12 months after the intervention.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline pain catastrophizing at 2, 6 and 12 months
timeFrame: Baseline, 2 months, 6 months, and 12 months after the intervention
Secondary outcomes:
measure: Change from baseline pain intensity and interference in daily activities at 2, 6 and 12 months
timeFrame: Baseline, 2 months, 6 months, and 12 months after the intervention
measure: Change from baseline pain acceptance at 2, 6 and 12 months
timeFrame: Baseline, 2 months, 6 months, and 12 months after the intervention
measure: Change from baseline health status at 2, 6 and 12 months
timeFrame: Baseline, 2 months, 6 months, and 12 months after the intervention
measure: Change from baseline health-related quality of life at 2, 6 and 12 months
timeFrame: Baseline, 2 months, 6 months, and 12 months after the intervention
measure: Change from baseline anxiety at 2, 6 and 12 months
timeFrame: Baseline, 2 months, 6 months, and 12 months after the intervention
measure: Change from baseline depression at 2, 6 and 12 months
timeFrame: Baseline, 2 months, 6 months, and 12 months after the intervention
measure: Use of medication and health care system at 2, 6 and 12 months
timeFrame: 2 months, 6 months, and 12 months after the intervention
Other outcomes:
measure: Satisfaction with the interventions at 2, 6 and 12 months
timeFrame: 2 months, 6 months, and 12 months after the intervention
Locations:
city: København
country: Denmark
facility: Rigshospitalet
state: København Ø.
Study officials:
affiliation: Rigshospitalet, Denmark
name: Geana Kurita, PhD
role: PRINCIPAL_INVESTIGATOR
References: