Chronic Non-Cancer Pain
Conditions
Keywords
Chronic non-cancer pain, Cognitive-behavioral program, Waiting list, Pain catastrophizing, Patient Reported Outcomes
Brief summary
The development of alternative methods to address simple clinical needs and easy interventions of self-application are desired in the pre-habilitation period (waiting list). To our knowledge that are very few studies regarding interventions for patients in waiting list for specialized treatment of chronic non-cancer pain (CNCP) and they do not include cognitive-behavioural programs. This project is based on the hypothesis that educational and cognitive-behavioural interventions help to reduce deleterious effects of pain on some areas of patient's life. Therefore, the goal is to test two different interventions to help patients to self-manage their pain and avoid worsening in the pre-clinical period.
Detailed description
It is a randomized controlled trial for application and assessment of two interventions: an educational Video-based Pain Program (VP) and Empowered Relief Program (ER). The primary purpose of our study is to investigate the effect of ER and VP on the Pain Catastrophizing Score in people with CNCP who are waiting for Multidisciplinary pain treatment. The secondary aim is to analyse the effects on other patient reported outcomes such as pain intensity, pain interference in daily activities, pain catastrophizing, pain acceptance, quality of life, mood, perceived change on over-all pain status, as well as consumption of pain medicine and usage of healthcare services. The effects of the two interventions will be compared with each other and a control group.
Interventions
BEHAVIORALEducational Video-based Pain Program
Educational videos with 10 modules with information about pain.
BEHAVIORALEmpowered Relief Program
Educational online session for skills acquisition to manage pain. Empowered Relief TM by Beth Darnall ©2013-2022 Stanford University
Sponsors
Rigshospitalet, Denmark
The Novo Nordic Foundation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistical analysis of data will be blinded.
Intervention model description
Randomized controlled trial for application and assessment of the two interventions. Patients waiting for multidisciplinary pain treatment at Rigshospitalet and Herlev/Gentofte Hospital will be invited to participate and randomly assigned to one of three arms (1:1:1): VP group, ER group or control group (no intervention). Assessments will occur at baseline, 2 months, 6 months, and 12 months after the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First appointment date at the Multidisciplinary Pain Centre scheduled at least three months after the invitation to participate in this study * At least 18 years old * Fluent in the Danish language * Access to internet * Willing and available to participate in the study
Exclusion criteria
* History of cognitive dysfunction that interfere with understanding of the educational program and answering the questionnaires * Epilepsy * Current history of severe depression * Current use of private pain services
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline pain catastrophizing at 2, 6 and 12 months | Baseline, 2 months, 6 months, and 12 months after the intervention | Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline pain intensity and interference in daily activities at 2, 6 and 12 months | Baseline, 2 months, 6 months, and 12 months after the intervention | Brief Pain Inventory to measure pain intensity and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life with other. |
| Change from baseline pain acceptance at 2, 6 and 12 months | Baseline, 2 months, 6 months, and 12 months after the intervention | Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score. |
| Change from baseline health status at 2, 6 and 12 months | Baseline, 2 months, 6 months, and 12 months after the intervention | The Measure Yourself Medical Outcome Profile (MYMOP 2), which measures effects on patient self generated outcome on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing. |
| Change from baseline health-related quality of life at 2, 6 and 12 months | Baseline, 2 months, 6 months, and 12 months after the intervention | RAND 36-Item Short Form Health Survey version 1.0 to assess 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. |
| Change from baseline anxiety at 2, 6 and 12 months | Baseline, 2 months, 6 months, and 12 months after the intervention | General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity. |
| Change from baseline depression at 2, 6 and 12 months | Baseline, 2 months, 6 months, and 12 months after the intervention | 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. |
| Use of medication and health care system at 2, 6 and 12 months | 2 months, 6 months, and 12 months after the intervention | Medication used (type and quantity), the number of times that he/she used the health care system because of chronic pain problem and treatment received (pharmacologic, surgical, rehabilitation, etc.), and number of absent days at work because of pain. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORGeana Kurita, PhD
Rigshospitalet, Denmark
Outcome results
None listed