Yoga-mindfulness for Pain Management in Inflammatory Arthritis - a Pragmatic Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Karolinska Institutet
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Symptom Impact Questionnaire- Revised (SIQR)
Study Overview
Brief Summary
This study evaluates the potential effects on pain, pain-related symptoms and quality of life of a yoga-mindfulness program, compared to patient education and physiotherapy, for patients with inflammatory arthritis and persistent pain problems.
Detailed Description
Earlier studies has indicated that body-mind therapies such as yoga and tai chi might be beneficial in the management of chronic pain syndromes. Chronic pain affects a large number of patients with inflammatory arthritis. Effective treatments are lacking for this patient group, so new treatment strategies are warranted.
The study is designed as randomized controlled trial where participants are allocated on a 1:1 ratio to either a 15 week intervention program of yoga-mindfulness or 15 weeks of patient education and mild physiotherapy.
Study outcomes include pain levels and other pain-related features such as fatigue, sleep problems, mood disturbances and functional disability as well as measurements of health-related quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is 18 years of age or older
- •Subject has a diagnosis of either rheumatoid arthritis or psoriatic arthritis
- •Subject has a total score on SIQR above 33
- •Subject has not changed anti-rheumatic or analgetic treatment strategies during the three months preceding study inclusion (dose changes of ongoing treatments are accepted)
Exclusion Criteria
- •Subject has another medical condition that might prevent the subjects full participation in the interventions
- •Subject has more than four swollen joints
- •Subject has a C-Reactive Protein more than 20 mg/L
- •Subject is currently practicing yoga or has practiced yoga regularly during the last six months prior to study inclusion
- •Subject does not speak Swedish
- •Subject is unwilling to comply with the study protocol
- •Subject is considered, by the investigator, to be an unsuitable candidate for the study
Outcomes
Primary Outcomes
Symptom Impact Questionnaire- Revised (SIQR)
Time Frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
SIQR is a questionnaire that captures the spectrum of symptoms usually associated to fibromyalgia. It consists of three domains (function, overall impact and symptoms) and includes questions about functional disability, level of disease burden and symptoms such as pain and pain-related features, e.g. fatigue, sleep problems, depression/anxiety etc. It is calculated into a score ranging from 0-100, where 0 means no symptoms. The score will be evaluated as change from baseline to study completion.
Secondary Outcomes
- Visual Analog Scale (VAS) of pain, fatigue and general health(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Hospital Anxiety and Depression Scale (HADS)(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Pain Catastrophizing Scale (PCS)(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Short Form-36 (SF-36)(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Individual domains of SIQR(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Disease Activity Score, 28 joints (DAS28)(At baseline and after 15 weeks of intervention.)
- Patient Global Impression of Change (PGIC)(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Chronic Pain Acceptance Questionnaire (CPAQ)(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Karolinska Sleep Questionnaire - 7 items (KSQ)(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
- Pain distribution(At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.)
Investigators
Jon Lampa
MD, Associate professor
Karolinska Institutet