Yoga-mindfulness for Pain Management in Inflammatory Arthritis

Karolinska Institute

Status: Suspended

Conditions: Psoriatic Arthritis; Pain; Rheumatoid Arthritis

Treatments: Behavioral: Patient education and physiotherapy; Behavioral: Yoga-mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT04065958

2017-88

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Yoga-mindfulness

Experimental group

Description:

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.

Treatment:

Behavioral: Yoga-mindfulness

Patient education and physiotherapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Patient education and physiotherapy