Preventive Interventions for Chronic Pain Worsening

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Non-Cancer Pain
• Intervention / Treatment: Behavioral: Online Mindfullness Based Stress Reduction Program; Device: Virtual Reality-based Pain Self-management program

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geana Kurita, PhD; Phone Number: 35454797; Email: geana.kurita@regionh.dk
• Study Contact Backup: Name: Suzanne F Forsyth Herling, PhD; Phone Number: 35458624; Email: suzanne.forsyth.herling.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBSR program; Participants will attend online group class/week for eight consecutive weeks. The MBSR will be based on the program adapted by the Multidisciplinary Pain Centre at Rigshospitalet (DK), which is tailored to patients with chronic pain. Each session has duration of 1.5 hours. Content is composed by meditation techniques and physical exercises, which focus on increasing awareness and acceptance of moment-to-moment experiences, including physical discomfort and difficult emotions.Two groups of 11-12 patients will be composed. However, individual meetings may be organized if the recruitment process shows difficulties to gather patients in groups. It will be delivered by a certified MBSR therapist and via Teams platform.	Behavioral: Online Mindfullness Based Stress Reduction Program; Online group class/week for eight consecutive weeks with 8 sessions; Other Names: MBSR
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.	Device: 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.; Other Names: VRPS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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)	At baseline, 2 months, 6 months, 9 months and 12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity and interference in daily activities	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	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Pain catastrophizing	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	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Pain acceptance	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)	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Health status	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	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Health related quality of life	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.	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Anxiety	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)	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Depression	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)	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Use of medication	Medication used (type and quantity) The information collected will refer to the period from patient inclusion to up one year follow-up.	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Use of healthcare system	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.	At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Number of absent days at work	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.	At baseline, 2 months, 6 months, 9 months and 12 months after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the intervention	Satisfaction with the interventions will be asked to the intervention groups by general questions about the intervention experienced with answers in a 6-point scale (0=completely dissatisfied to 5= completely satisfied) and there will be space to write comments.	At baseline, 2 months, 6 months, 9 months and 12 months after intervention

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: The Novo Nordic Foundation
• Investigators: Principal Investigator: Geana Kurita, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Virtual Reality; Patient Reported Outcome; Pain Intensity; Non-pharmacological treatment; Mindfulness Based Stress Reduction Program
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: NCT05178082_WP3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No