Preventive Interventions for Chronic Pain Worsening

Chronic Non-Cancer Pain Clinical Trial

Official title: Preventive Interventions for Chronic Pain Worsening

Status Not yet recruiting

Clinical Trial 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 three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 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.

Clinical Trial 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 homebased interventions connecting these two areas. Here, the effects of an online delivered standardized mindfulness-based stress reduction program and non-pharmacological techniques delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. Both interventions target primarily pain relief by providing pain regulating strategies.

The investigators will test the main hypothesis that participants assigned to Mindfulness-Based Stress Reduction (MBSR) or 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 MBSR and 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 both interventions 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. In addition, the effects of the two interventions will be compared. ;

Related Conditions & MeSH terms

• Chronic Non-Cancer Pain
• Chronic Pain

• NCT number: NCT06351046
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Contact: Geana Kurita, PhD
• Phone: 35454797
• Email: geana.kurita@regionh.dk
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Completion date: January 30, 2027