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Completed

NCT Number: NCT05178082

Pre-habilitation Interventions to Empower Patients With Chronic Pain

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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Key information

Conditions

Chronic Non-cancer Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, København Ø., 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Video-based Pain Program

Behavioral

Educational videos with 10 modules with information about pain.

Other names: VP

Empowered Relief Program

Behavioral

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

Other names: ER

Primary outcomes

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

    Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention

    Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score

Secondary outcomes

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

    Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention

    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.

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

    Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention

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

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

    Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention

    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.

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

    Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention

    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.

  5. Change from baseline anxiety at 2, 6 and 12 months

    Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention

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

  6. Change from baseline depression at 2, 6 and 12 months

    Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention

    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.

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

    Time frame: 2 months, 6 months, and 12 months after the intervention

    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.

Other outcomes

  1. Satisfaction with the interventions at 2, 6 and 12 months

    Time frame: 2 months, 6 months, and 12 months after the intervention

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • The Novo Nordic Foundation

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 5, 2022
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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