Pre-habilitation Interventions to Empower Patients With Chronic Pain

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Educational Video-based Pain Program

Empowered Relief Program

About this trial

This is an interventional treatment trial for Chronic Non-Cancer Pain focused on measuring Chronic non-cancer pain, Cognitive-behavioral program, Waiting list, Pain catastrophizing, Patient Reported Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 18 years old
Fluent in the Danish language
Identified with complex chronic pain and referred to multidisciplinary pain treatment
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
Previous or current multidisciplinary pain treatment

Sites / Locations

RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

VP group

ER group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05178082

First Posted

November 25, 2021

Last Updated

May 31, 2023

Sponsor

Rigshospitalet, Denmark

Collaborators

The Novo Nordic Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05178082

Brief Title

Pre-habilitation Interventions to Empower Patients With Chronic Pain

Official Title

Pre-habilitation Interventions to Empower Patients With Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 31, 2023 (Anticipated)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

The Novo Nordic Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Non-Cancer Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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.

Masking

None (Open Label)

Masking Description

Statistical analysis of data will be blinded.

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VP group

Arm Type

Experimental

Arm Description

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.

Arm Title

ER group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Educational Video-based Pain Program

Other Intervention Name(s)

VP

Intervention Description

Educational videos with 10 modules with information about pain.

Intervention Type

Behavioral

Intervention Name(s)

Empowered Relief Program

Other Intervention Name(s)

ER

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score

Time Frame

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

Secondary Outcome Measure Information:

Title

Change from baseline pain intensity and interference in daily activities at 2, 6 and 12 months

Description

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.

Time Frame

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

Title

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

Description

Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

Change from baseline health-related quality of life at 2, 6 and 12 months

Description

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.

Time Frame

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

Title

Change from baseline anxiety at 2, 6 and 12 months

Description

General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity.

Time Frame

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

Title

Change from baseline depression at 2, 6 and 12 months

Description

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.

Time Frame

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

Title

Use of medication and health care system at 2, 6 and 12 months

Description

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.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Satisfaction with the interventions at 2, 6 and 12 months

Description

One general question about satisfaction with the intervention used (6-point scale) and additional comments.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Geana Kurita, PhD

Phone

+4535454797

Email

geana.kurita@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Suzanne Herling, PhD

Phone

+4535458624

Email

suzanne.forsyth.herling.01@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geana Kurita, PhD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

København

State/Province

København Ø.

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Geana Kurita, PHD.

First Name & Middle Initial & Last Name & Degree

Suzanne Herling, PHD

12. IPD Sharing Statement

Plan to Share IPD

No

Chronic Non-Cancer Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial