Yoga-mindfulness for Pain Management in Inflammatory Arthritis

NCT ID: NCT04065958

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Rheumatoid Arthritis Psoriatic Arthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yoga-mindfulness

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.

Group Type EXPERIMENTAL

Yoga-mindfulness

Intervention Type BEHAVIORAL

Body-mind therapy

Patient education and physiotherapy

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.

Group Type ACTIVE_COMPARATOR

Patient education and physiotherapy

Intervention Type BEHAVIORAL

Lectures and physiotherapy

Interventions

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Yoga-mindfulness

Body-mind therapy

Intervention Type BEHAVIORAL

Patient education and physiotherapy

Lectures and physiotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro County Council

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Jon Lampa

MD, Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon Lampa, MD, As.Prof.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital / Karolinska Institute

Locations

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University Hospital Örebro

Örebro, , Sweden

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 20818876 (View on PubMed)

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.

Reference Type RESULT
PMID: 20946990 (View on PubMed)

Other Identifiers

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2017-88

Identifier Type: -

Identifier Source: org_study_id

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