Yoga-mindfulness for Pain Management in Inflammatory Arthritis

Karolinska Institutet60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis Psoriatic Arthritis Pain

Interventions

Yoga-mindfulnessBEHAVIORAL

Body-mind therapy

Patient education and physiotherapyBEHAVIORAL

Lectures and physiotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Örebro

Örebro, Sweden

Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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