Clinical trial NCT04065958: Yoga-mindfulness for Pain Management in Inflammatory Arthritis
Official title: Yoga-mindfulness for Pain Management in Inflammatory Arthritis - a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Pain
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Örebro County Council
First posted: 2019-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Symptom Impact Questionnaire- Revised (SIQR)
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Pain Catastrophizing Scale (PCS)
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Karolinska Sleep Questionnaire - 7 items (KSQ)
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Short Form-36 (SF-36)
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Individual domains of SIQR
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Visual Analog Scale (VAS) of pain, fatigue and general health
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Pain distribution
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
measure: Disease Activity Score, 28 joints (DAS28)
timeFrame: At baseline and after 15 weeks of intervention.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Örebro
country: Sweden
facility: University Hospital Örebro
Study officials:
affiliation: Karolinska University Hospital / Karolinska Institute
name: Jon Lampa, MD, As.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.