Rheumatoid ArthritisNCT04065958
Yoga-mindfulness for Pain Management in Inflammatory Arthritis
A study testing Yoga-mindfulness and Patient education and physiotherapy in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Pain
- What is being tested?
- Yoga-mindfulness and Patient education and physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSweden
- Study dates
- 19 Aug 2019to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital Örebro
Örebro, 701 85
Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: Yoga-mindfulness for Pain Management in Inflammatory Arthritis - a Pragmatic Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Pain
- Being tested
- Yoga-mindfulness, Patient education and physiotherapy
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-mindfulnessBehavioural
Body-mind therapy
Patient education and physiotherapyBehavioural
Lectures and physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Yoga-mindfulness |
| 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. Receives: Behavioral: Patient education and physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start19 Aug 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: 1st: Covid-19 pandemic. 2nd: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro County Council
- Responsible party
- Principal investigator, Jon Lampa, Karolinska Institutet
- Investigators
- Jon Lampa, MD, As.Prof., Principal investigator, Karolinska University Hospital / Karolinska Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065958
- Sponsor's protocol ID
- 2017-88
- Status last verified
- Jul 2022
- First submitted
- 21 Aug 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20818876Carson 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.
PubMed 20946990
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga-mindfulness for Pain Management in Inflammatory Arthritis - a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04065958
- Acronym / sponsor ID
- 2017-88
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 1st: Covid-19 pandemic. 2nd: Lack of resources
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Örebro County Council
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga-mindfulness | Experimental | Behavioral: Yoga-mindfulnessYoga-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 comparator | Behavioral: Patient education and physiotherapyPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga-mindfulnessBody-mind therapy | Behavioural | Yoga-mindfulness |
| Patient education and physiotherapyLectures and physiotherapy | Behavioural | Patient education and physiotherapy |
Primary outcome
Symptom Impact Questionnaire- Revised (SIQR)
Time frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
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.
10 secondary outcomes
Patient Global Impression of Change (PGIC)
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)
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)
Time frame: 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)
Time frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Short Form-36 (SF-36)
Time frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Individual domains of SIQR
Time frame: 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
Time frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Pain distribution
Time frame: 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)
Time frame: At baseline and after 15 weeks of intervention.
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Results publication: PubMed 20818876Wang 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.
- Results publication: PubMed 20946990Carson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Lampa, MD, As.Prof. principal investigator
Karolinska University Hospital / Karolinska Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga-mindfulness and Patient education and physiotherapy in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Impact Questionnaire- Revised (SIQR) (time frame: At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.