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NCT Number: NCT06351046

Preventive Interventions for Chronic Pain Worsening

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.

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Key information

Conditions

Chronic Non-cancer Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, København Ø., 2100, Denmark

Location status: Recruiting

Location contact

Geana Kurita, PHD.

CONTACT

Suzanne Herling, PHD

CONTACT

About this study

Considering the need of interventions to improve pain self-management to interrupt the "pain chronification" process and the indications regarding advantages of cognitive behavioral techniques and technologic resources, the purpose of this study is to test a homebased intervention connecting these areas. Here, the effects of a non-pharmacological technique delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. The intervention target primarily pain relief by providing pain regulating strategies.

The investigators will test the main hypothesis that participants assigned Virtual Reality-based Pain Self-management program (VRPS) present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6-, 9-, and 12-months follow-up when compared to treatment as usual (control group).The primary aim is to investigate the effects of VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-intervention.The secondary aims are to analyze the effects of the intervention on other patient-reported outcomes measures (PROMs), which are pain intensity at follow-ups, pain interference in daily activities, pain catastrophizing, pain acceptance, health-related quality of life, anxiety, depression, perceived change on over-all pain status, use of analgesic medication, and use of health care system among patients with non-cancer pain lasting 3 months or more.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years old
  • Fluent in the Danish language
  • Complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10)
  • Access to internet
  • Willing and available to participate in the study.

Exclusion criteria

  • Specialized or multidisciplinary pain treatment at baseline
  • History of epilepsy
  • Seizure disorder
  • History of nausea or dizziness
  • Hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment.
  • Injury to eyes, face or neck that impedes comfortable use of virtual reality equipment.
  • Current cancer disease
  • Medical diagnosis of depression
  • Cognitive dysfunction that interferers with compliance to the study,
  • Currently pregnant or planning to become pregnant during the study period
  • No access to the internet during the study period.

Treatment and study plan

Virtual Reality-based Pain Self-management program

Device

The VRPS has a variety of modules that can be used for pain management. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules. All modules were designed to minimize triggers of emotional distress or cybersickness.

Other names: VRPS

Primary outcomes

  1. Pain intensity

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    Pain intensity for worst pain in the last 24h: Brief Pain Inventory to measure pain intensity, from no pain (0) to worst pain ever (10)

Secondary outcomes

  1. Pain intensity and interference in daily activities

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    Brief Pain Inventory to measure pain intensity from no pain (0) to worst pain ever (10) at follow-ups and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life

  2. Pain catastrophizing

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    Pain Catastrophizing Scale, using a 5-point Likert scale ranging from 0 (never) to 4 (always) to assess patterns of negative cognition and emotion in the context of actual or anticipated pain

  3. Pain acceptance

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score, using a rating scale from 0 to 6. Never true (0) to always true (6)

  4. Health status

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    patient-generated outcome assessed by the Measure Yourself Medical Outcome Profile (MYMOP2), which measures effects from health care interventions on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing

  5. Health related quality of life

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    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 using the RAND 36-Item Short Form Health Survey version 1.0. First, precoded numeric values are recoded per the scoring key. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

  6. Anxiety

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity. Measured on a rating scale,- "from not at all" (0) to "almost every day" (3)

  7. Depression

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after 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. Measured on a rating scale,- from "not at all" (0) to "almost every day" (3)

  8. Use of medication

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    Medication used (type and quantity) The information collected will refer to the period from patient inclusion to up one year follow-up.

  9. Use of healthcare system

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    The number of times that he/she used the health care system because of his chronic pain problem and treatment received (pharmacologic, surgical, rehabilitation, etc.). The information collected will refer to the period from patient inclusion to up one year follow-up.

  10. Number of absent days at work

    Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention

    Number of absent days at work because of pain will be asked directly to the patients through the electronic forms. The information collected will refer to the period from patient inclusion to up one year follow-up.

Other outcomes

  1. Satisfaction with the intervention

    Time frame: At 2 months, 6 months, 9 months and 12 months after intervention

    Satisfaction with the intervention will be asked to the intervention group by general questions about the intervention experienced with answers in a 6-point scale (0=completely dissatisfied to 5= completely satisfied) and there will be space to write comments.

Study contacts

Contact information is provided by the study sponsor or research team.

Geana Kurita, PhD

CONTACT

[email protected]

35454797

Suzanne F Forsyth Herling, PhD

CONTACT

[email protected]

35458624

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • The Novo Nordic Foundation

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
Jul 9, 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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