Preventive Interventions for Chronic Pain Worsening

NCT ID: NCT06351046

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-01-30

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.

Conditions

Chronic Non-Cancer Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VRPS program

VRPS is based on four evidence-based principles of cognitive-behavioral therapy and pain neuroscience education. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules.The eight consecutive weeks program period of intervention is composed of one initial physical meeting with 1h duration to explain the basis/principles of the virtual tools offered, how the virtual appliance works and should be used, including safety recommendations as calm environment at home, sitting or lying position during use. Groups of maximum 13 patients will be organized. Patients will be instructed to use the equipment at least once a day and it can be used as many times as they wish per day aiming to reduce pain intensity or to avoid pain. Patients will also be asked to keep a diary to register the equipment use during the study period to secure the data.

Group Type: EXPERIMENTAL

Virtual Reality-based Pain Self-management program

Intervention Type: 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.

Control group

Participants in the control group will not receive any of the interventions. This study will not interfere with medical treatment plan and patients from the three groups can receive other pain treatment prescribed by physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality-based Pain Self-management program

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.

Intervention Type: DEVICE

Other Intervention Names

VRPS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Novo Nordic Foundation

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Geana P Kurita

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geana Kurita, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Central Contacts

Geana Kurita, PhD

Role: CONTACT

geana.kurita@regionh.dk

35454797

Suzanne F Forsyth Herling, PhD

Role: CONTACT

suzanne.forsyth.herling.01@regionh.dk

35458624

Other Identifiers

NCT05178082_WP3

Identifier Type: -

Identifier Source: org_study_id