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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
163
Educational videos with 10 modules with information about pain.
Educational online session for skills acquisition to manage pain. Empowered Relief TM by Beth Darnall ©2013-2022 Stanford University
Rigshospitalet
Copenhagen, København Ø., Denmark
Change from baseline pain catastrophizing at 2, 6 and 12 months
Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score
Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention
Change from baseline pain intensity and interference in daily activities at 2, 6 and 12 months
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.
Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention
Change from baseline pain acceptance at 2, 6 and 12 months
Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score.
Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention
Change from baseline health status at 2, 6 and 12 months
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.
Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention
Change from baseline health-related quality of life at 2, 6 and 12 months
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.
Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention
Change from baseline anxiety at 2, 6 and 12 months
General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity.
Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention
Change from baseline depression at 2, 6 and 12 months
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.
Time frame: Baseline, 2 months, 6 months, and 12 months after the intervention
Use of medication and health care system at 2, 6 and 12 months
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.
Time frame: 2 months, 6 months, and 12 months after the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.