Pre-habilitation Interventions to Empower Patients With Chronic Pain

NCT05178082 | Completed

• 1 other identifier: Pre-habilitation interventions
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Non-Cancer Pain

Keywords

Chronic non-cancer pain; Cognitive-behavioral program; Waiting list; Pain catastrophizing; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain catastrophizing at 2, 6 and 12 months

  Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score

  Baseline, 2 months, 6 months, and 12 months after the intervention

Secondary Outcomes (7)

• 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

• Change from baseline pain acceptance at 2, 6 and 12 months

  Baseline, 2 months, 6 months, and 12 months after the intervention

• Change from baseline health status at 2, 6 and 12 months

  Baseline, 2 months, 6 months, and 12 months after the intervention

• 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

• Change from baseline anxiety at 2, 6 and 12 months

  Baseline, 2 months, 6 months, and 12 months after the intervention

Other Outcomes (1)

• Satisfaction with the interventions at 2, 6 and 12 months

  2 months, 6 months, and 12 months after the intervention

Study Arms (3)

VP group

EXPERIMENTAL

Participants are linked to online informative videos on chronic pain produced by the Multidisciplinary Pain Centre (Rigshospitalet, DK). Ten video-modules of 2-6 minutes each. 1. Chronic pain development in Denmark, treatment offered at the Centre. 2. How chronic pain can affect life in all its facets. Chronic complex pain explained. 3. Psychological models used to describe affected life domains. The role of dysfunctional thoughts on e.g. anxiety. 4. The connection between pain and factors that can reduce energy level. 5. Pain interference in the familiar dynamic and relations. 6. Information about how to balance activity and rest - and on daily breathing exercises. 7. The Rules and opportunities when health challenges working life e.g. work relocation. 8. The importance of healthy habits regarding eating, sleep, and self-treating. 9. Selection of medication according to the patient's quality of life. 10. Expected side effects of medication and on measures to counteract side effects.

Behavioral: Educational Video-based Pain Program

ER group

EXPERIMENTAL

Participants will attend a single-session, 2-hour online group class. The program has two main components: didactics and skills acquisition. Participants will learn about pain self-regulation and self-management. The program content includes strategies to empower individuals with chronic non-cancer pain as following: 1) the identification of unhelpful thought patterns in the moment, 2) regulation of cognition and emotion, including thought reframing and mindset, 3) how to decrease physiological hyperarousal using relaxation techniques (binaural relaxation audio file for diaphragmatic breathing and progressive muscle relaxation), and 4) establishing self-soothing actions. At the end of the class, participants will develop a self-tailored plan for implementing these skills/strategies in daily life to use behaviors that modulate attention and counteract helplessness (Darnall et al 2014). The online class will be delivered by a nurse certified in the ER.

Behavioral: Empowered Relief Program

Control group

NO INTERVENTION

Participants in the control group will not receive any of the interventions. This project will not interfere with any current or future pain treatment. After the end of collecting data, the Multidisciplinary Pain Centre will eventually make available the videos that compose VP to all patients.

Interventions

Educational Video-based Pain Program BEHAVIORAL

Educational videos with 10 modules with information about pain.

Also known as: VP

VP group

Empowered Relief Program BEHAVIORAL

Educational online session for skills acquisition to manage pain. Empowered Relief TM by Beth Darnall ©2013-2022 Stanford University

Also known as: ER

ER group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Novo Nordic Foundation: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, København Ø., 2100, Denmark

Location

Study Officials

• Geana Kurita, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analysis of data will be blinded.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: January 5, 2022
• Study Start: May 31, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 30, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)