Preventive Interventions for Chronic Pain Worsening

Chronic Non-Cancer Pain Clinical Trial

Official title:

Preventive Interventions for Chronic Pain Worsening

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351046
• Other study ID #: NCT05178082_WP3
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: January 30, 2027

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Geana Kurita, PhD
• Phone: 35454797
• Email: geana.kurita[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: January 30, 2027
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Non-Cancer Pain
• Chronic Pain

Intervention

Behavioral:
• Online Mindfullness Based Stress Reduction Program
Online group class/week for eight consecutive weeks with 8 sessions

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Novo Nordic Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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