Clinical trial NCT06351046: Preventive Interventions for Chronic Pain Worsening
Official title: Preventive Interventions for Chronic Pain Worsening
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Non-Cancer Pain
Keywords: Patient Reported Outcome
Virtual Reality
Pain Intensity
Randomized Controlled Trial
Non-pharmacological treatment
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
First posted: 2024-04-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Secondary outcomes:
measure: Pain intensity and interference in daily activities
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Pain catastrophizing
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Pain acceptance
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Health status
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Health related quality of life
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Anxiety
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Depression
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Use of medication
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Use of healthcare system
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
measure: Number of absent days at work
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Other outcomes:
measure: Satisfaction with the intervention
timeFrame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Geana Kurita, PhD
role: PRINCIPAL_INVESTIGATOR
References: