Study Stopped
1st: Covid-19 pandemic. 2nd: Lack of resources
Yoga-mindfulness for Pain Management in Inflammatory Arthritis
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Aug 2019
Longer than P75 for not_applicable rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2019
CompletedFirst Submitted
Initial submission to the registry
August 21, 2019
CompletedFirst Posted
Study publicly available on registry
August 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 13, 2022
July 1, 2022
4.3 years
August 21, 2019
July 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Patient Global Impression of Change (PGIC)
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Chronic Pain Acceptance Questionnaire (CPAQ)
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Pain Catastrophizing Scale (PCS)
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)
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Short Form-36 (SF-36)
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
- +5 more secondary outcomes
Study Arms (2)
Yoga-mindfulness
EXPERIMENTALYoga-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.
Patient education and physiotherapy
ACTIVE COMPARATORPatient 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.
Interventions
Lectures and physiotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Örebro County Councilcollaborator
Study Sites (2)
University Hospital Örebro
Örebro, 701 85, Sweden
Karolinska University Hospital
Stockholm, 171 76, Sweden
Related Publications (2)
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.
PMID: 20818876RESULTCarson 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.
PMID: 20946990RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Lampa, MD, As.Prof.
Karolinska University Hospital / Karolinska Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Associate professor
Study Record Dates
First Submitted
August 21, 2019
First Posted
August 22, 2019
Study Start
August 19, 2019
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
July 13, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share