Yoga-mindfulness for Pain Management in Inflammatory Arthritis

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.

Official Title
-----------------
Yoga-mindfulness for Pain Management in Inflammatory Arthritis - a Pragmatic Randomized Controlled Trial

Conditions
-----------------
Rheumatoid Arthritis, Psoriatic Arthritis, Pain

Intervention / Treatment
-----------------
* Behavioral: Yoga-mindfulness
* Behavioral: Patient education and physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga-mindfulness<br>Yoga-mindfulness program consisting of movements/postures (asanas), breathing practices, relaxation practices and meditation practices, together with brief talks on yoga-based coping strategies. The intervention starts with a introductory lecture and is then followed by one session per week, á 90 minutes, for 15 weeks, with home assignments for about 30 minutes per day, four days per week. | Behavioral: Yoga-mindfulness<br>* Body-mind therapy<br>|
| Active Comparator: Patient education and physiotherapy<br>Patient education program consisting of lectures on topics related to inflammatory arthritis and pain together with mild physiotherapy. The interventions starts with an introductory lecture and is then followed by one session per week, á 90 minutes, for 15 weeks. Each session consists of a lecture and a program of instructed physiotherapy. Besides the weekly sessions, home assignments consisting of 30 minutes of walking, are performed four days per week. | Behavioral: Patient education and physiotherapy<br>* Lectures and physiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Impact Questionnaire- Revised (SIQR) | 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. | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change (PGIC) | Overall impression of change in symptoms during the study period. PGIC consists of a 7-point scale, ranging from 1 (Very Much Improved) to 7 (Very Much Worse). | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. | 
| Chronic Pain Acceptance Questionnaire (CPAQ) | Nineteen items form the CPAQ (Wicksell et al. Eur J Pain. 2009;13(7):760-8) assessing coping strategies and acceptance in relation to chronic pain. The 19 items are divided in two categories: Activity engagement and Pain willingness. The items are rated on a 7-point scale from 0 (never true) to 6 (always true). For Activity engagement the scores are summed and for Pain willingness the scores are reversed and then summed. To obtain the total score, the scores for each category are summed. The total score ranges from 0-114, with higher scores indicating higher level of acceptance. | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. | 
| Pain Catastrophizing Scale (PCS) | Assessment of negative thoughts (catastrophizing) in relation to pain. PCS is a 13-item instrument, where each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (all the time). The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. The PCS total score is computed by summing responses to all 13 items. Total score ranges from 0-52, where a higher number indicates more catastrophizing. The rumination subscale ranges from 0-16, the magnification subscale ranges from 0-12 and the helplessness subscale ranges from 0-24. | 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) | Seven questions from the KSQ, assessing of features of sleep quality. Each questions is scored on 6 levels, from 0-5. The scores are summed to produce a global score (range 0-35). Higher scores indicate worse sleep quality. | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. | 
| Short Form-36 (SF-36) | Assessment of health-related quality of life (HRQoL). SF-36 evaluates HRQoL in eight components, each component is scored on a scale ranging from 0-100, where higher scores indicate a more favorable health state. | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. | 
| Individual domains of SIQR | Each of the three domains of SIQR will be assessed separately. The function domain ranges from 0-30, with higher scores indicating more functional disability. The overall impact domain ranges from 0-20 with higher scores indicating a larger overall impact. The symptom domain ranges from 0-50 with higher scores indicating more symptoms. | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. | 
| Visual Analog Scale (VAS) of pain, fatigue and general health | Commonly assessed features in inflammatory arthritis, depicted on VAS-scales. The scales range from 0-100, with higher scores indicating worse symptoms. | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. | 
| Pain distribution | Pain distribution, depicted on a pain mannequin. | 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) | Disease activity measure used in rheumatic joint diseases. Constitutes a composite score based on an assessment of number of swollen and tender joints as well as inflammatory markers in blood samples and both patients and physicians ratings of disease activity. The score ranges from 0-9.4 with higher scores indicating worse symptoms. | At baseline and after 15 weeks of intervention. | 
| Hospital Anxiety and Depression Scale (HADS) | HADS contains 14 items assessing features of anxiety and depression. Each question is scored on a 4-level scale (ranging from 0-3). Seven of the questions assess features of anxiety and the other seven questions assess features of depression. Each subscale has a total range of 0-21 with higher scores indicating worse symptoms. | At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period. |