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Yoga-mindfulness for Pain Management in Inflammatory Arthritis

Primary Purpose

Rheumatoid Arthritis, Psoriatic Arthritis, Pain

Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Yoga-mindfulness
Patient education and physiotherapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Karolinska University Hospital
  • University Hospital Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga-mindfulness

Patient education and physiotherapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
Pain distribution
Pain distribution, depicted on a pain mannequin.
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.
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.

Full Information

First Posted
August 21, 2019
Last Updated
July 11, 2022
Sponsor
Karolinska Institutet
Collaborators
Örebro County Council
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1. Study Identification

Unique Protocol Identification Number
NCT04065958
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Suspended
Why Stopped
1st: Covid-19 pandemic. 2nd: Lack of resources
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Örebro County Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriatic Arthritis, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga-mindfulness
Arm Type
Experimental
Arm 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.
Arm Title
Patient education and physiotherapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga-mindfulness
Intervention Description
Body-mind therapy
Intervention Type
Behavioral
Intervention Name(s)
Patient education and physiotherapy
Intervention Description
Lectures and physiotherapy
Primary Outcome Measure Information:
Title
Symptom Impact Questionnaire- Revised (SIQR)
Description
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 Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC)
Description
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.
Title
Chronic Pain Acceptance Questionnaire (CPAQ)
Description
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.
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Title
Karolinska Sleep Questionnaire - 7 items (KSQ)
Description
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.
Time Frame
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Title
Short Form-36 (SF-36)
Description
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.
Time Frame
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Title
Individual domains of SIQR
Description
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.
Time Frame
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Title
Visual Analog Scale (VAS) of pain, fatigue and general health
Description
Commonly assessed features in inflammatory arthritis, depicted on VAS-scales. The scales range from 0-100, with higher scores indicating worse symptoms.
Time Frame
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Title
Pain distribution
Description
Pain distribution, depicted on a pain mannequin.
Time Frame
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.
Title
Disease Activity Score, 28 joints (DAS28)
Description
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.
Time Frame
At baseline and after 15 weeks of intervention.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
At baseline, after 5, 10 and 15 weeks of intervention as well as 12 weeks after the intervention period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Lampa, MD, As.Prof.
Organizational Affiliation
Karolinska University Hospital / Karolinska Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
University Hospital Örebro
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20818876
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.
Results Reference
result
PubMed Identifier
20946990
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.
Results Reference
result

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Yoga-mindfulness for Pain Management in Inflammatory Arthritis

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