Preventive Interventions for Chronic Pain Worsening

Not Applicable

Not yet recruiting

• Conditions: Chronic Non-Cancer Pain

• Registration Number: NCT06351046
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-03-27
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-08
• Last Update Submitted: 2025-02-27
• Study Start: 2025-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-07-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Pain intensity	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 Outcome Measures

Name	Time	Method
Pain catastrophizing	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
Health status	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
Use of medication	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.
Pain intensity and interference in daily activities	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
Pain acceptance	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)
Health related quality of life	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.
Depression	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)
Use of healthcare system	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.
Anxiety	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)
Number of absent days at work	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.