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Chronic Non-Cancer PainNCT05178082

Pre-habilitation Interventions to Empower Patients With Chronic Pain

A study testing Educational Video-based Pain Program and Empowered Relief Program in people with Chronic Non-Cancer Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Non-Cancer Pain
What is being tested?
Educational Video-based Pain Program and Empowered Relief Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
1 siteDenmark
Study dates
31 May 2023to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen, København Ø., 2100

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
Educational Video-based Pain Program, Empowered Relief Program
Keywords
Chronic non-cancer pain, Cognitive-behavioral program, Waiting list, Pain catastrophizing, Patient Reported Outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational Video-based Pain ProgramBehavioural

    Also called VP

    Educational videos with 10 modules with information about pain.

  • Empowered Relief ProgramBehavioural

    Also called ER

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

Study groups in NCT05178082
Study groupRoleWhat they receive
VP groupExperimentalParticipants 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.
Receives: Behavioral: Educational Video-based Pain Program
ER groupExperimentalParticipants 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.
Receives: Behavioral: Empowered Relief Program
Control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score

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

Secondary outcomes (7)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start31 May 2023
  3. Primary completion17 Jun 2024
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178082
Sponsor's protocol ID
Pre-habilitation interventions
Status last verified
Feb 2026
First submitted
25 Nov 2021
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational Video-based Pain Program and Empowered Relief Program in people with Chronic Non-Cancer Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline pain catastrophizing at 2, 6 and 12 months (time frame: Baseline, 2 months, 6 months, and 12 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178082.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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