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Preventive Interventions for Chronic Pain Worsening

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Geana Kurita, PhD
geana.kurita@regionh.dk
35454797
Backup
Suzanne F Forsyth Herling, PhD
suzanne.forsyth.herling.01@regionh.dk
35458624
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 44
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: The Novo Nordic Foundation
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov