Pre-habilitation Interventions to Empower Patients With Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Non-Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Statistical analysis of data will be blinded.

Study Groups

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VP group

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.

Group Type EXPERIMENTAL

Educational Video-based Pain Program

Intervention Type BEHAVIORAL

Educational videos with 10 modules with information about pain.

ER group

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.

Group Type EXPERIMENTAL

Empowered Relief Program

Intervention Type BEHAVIORAL

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational Video-based Pain Program

Educational videos with 10 modules with information about pain.

Intervention Type BEHAVIORAL

Empowered Relief Program

Intervention Type BEHAVIORAL

Other Intervention Names

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VP ER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No