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1st: Covid-19 pandemic. 2nd: Lack of resources
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| Name | Class |
|---|---|
| Örebro County Council | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga-mindfulness | Experimental | 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. |
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| Patient education and physiotherapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga-mindfulness | Behavioral | Body-mind therapy |
| |
| Patient education and physiotherapy |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Lampa, MD, As.Prof. | Karolinska University Hospital / Karolinska Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Örebro | Örebro | 701 85 | Sweden | |||
| Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20818876 | Result | Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611. | |
| 20946990 | Result | Carson JW, Carson KM, Jones KD, Bennett RM, Wright CL, Mist SD. A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia. Pain. 2010 Nov;151(2):530-539. doi: 10.1016/j.pain.2010.08.020. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Behavioral |
Lectures and physiotherapy |
|
| 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. |
| Stockholm |
| 171 76 |
| Sweden |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |