Pre-habilitation Interventions to Empower Patients With Chronic Pain

Chronic Non-Cancer Pain Clinical Trial

Official title:

Pre-habilitation Interventions to Empower Patients With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05178082
• Other study ID #: Pre-habilitation interventions
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Rigshospitalet, Denmark
• Contact: Geana Kurita, PhD
• Phone: +4535454797
• Email: geana.kurita[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Non-Cancer Pain
• Chronic Pain

Intervention

Behavioral:
• Educational Video-based Pain Program
Educational videos with 10 modules with information about pain.
• Empowered Relief Program
Educational online session for skills acquisition to manage pain. Empowered Relief TM by Beth Darnall ©2013-2022 Stanford University

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København	København Ø.

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Novo Nordic Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with the interventions at 2, 6 and 12 months	One general question about satisfaction with the intervention used (6-point scale) and additional comments.	2 months, 6 months, and 12 months after the intervention
Primary	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	Change from baseline pain intensity and interference in daily activities at 2, 6 and 12 months	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.	Baseline, 2 months, 6 months, and 12 months after the intervention
Secondary	Change from baseline pain acceptance at 2, 6 and 12 months	Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score.	Baseline, 2 months, 6 months, and 12 months after the intervention
Secondary	Change from baseline health status at 2, 6 and 12 months	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.	Baseline, 2 months, 6 months, and 12 months after the intervention
Secondary	Change from baseline health-related quality of life at 2, 6 and 12 months	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.	Baseline, 2 months, 6 months, and 12 months after the intervention
Secondary	Change from baseline anxiety at 2, 6 and 12 months	General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity.	Baseline, 2 months, 6 months, and 12 months after the intervention
Secondary	Change from baseline depression at 2, 6 and 12 months	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.	Baseline, 2 months, 6 months, and 12 months after the intervention
Secondary	Use of medication and health care system at 2, 6 and 12 months	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.	2 months, 6 months, and 12 months after the intervention