- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171274
Effects of Hatha Yoga on Chronic Neck Pain
Randomisierte Kontrollierte Studie Zum Einfluss Von Hatha Yoga Auf Sensorische Schwellen, Kinästhetik Und Körperbild Bei Patienten Mit Chronischen Nackenschmerzen
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hatha Yoga is a traditional system of exercises, used in India for the relief of painful condition since centuries and gaining more and more interest in Europe and the US. The efficacy of Hatha Yoga for relieving chronic low back pain has been repeatedly demonstrated in clinical trials, while there are no studies in the literature regarding chronic neck pain. The aim of this study is to investigate, whether a 9 weeks-course of Hatha Yoga reduces subjective pain ratings and disability in patients suffering from chronic neck pain. Furthermore, as neck pain patients have been shown to suffer from impaired sensory processing and proprioception, along with restricted range of motion, the study aims to test if Hatha Yoga can improve these variables. Therefore, tests regarding cervicocephalic proprioception, active range of motion and the processing of mechanical, vibration and pain stimuli will be included.
58 patients with chronic nonspecific neck pain will be randomized to either Hatha Yoga group or control group, receiving information regarding exercises for chronic neck pain. The control group will be offered to take part in a Yoga class after the end of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Northrhine-Westphalia
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Essen, Northrhine-Westphalia, Germany, 45276
- Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic mechanical neck pain, at least 40 mm on the 100mm visual analog scale.
- Pain for at least 3 months.
Exclusion Criteria:
- radicular symptoms
- congenital spine deformity
- pregnancy
- rheumatic diseases
- oncologic diseases
- other severe psychiatric or somatic comorbidity
- recent invasive or surgical treatment of the spine
- regularly yoga practice participation in other studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hatha Yoga
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Active Comparator: Exercise information
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain intensity (100mm visual analog scale)
Time Frame: Week 10
|
100mm visual analog scale
|
Week 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervicocephalic kinesthetic sensibility
Time Frame: Week 10
|
The ability to exactly relocate the head on the trunk in a self-chosen "neutral" forward-position after an active movement. according to: Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991;72:288-91. |
Week 10
|
|
Active range of motion
Time Frame: Week 10
|
6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left)
|
Week 10
|
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Pain related to motion
Time Frame: Week 10
|
100mm visual analog scale for 6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left) according to: Irnich D, Behrens N, Molzen H, König A, Gleditsch J, Krauss M, Natalis M, Senn E, Beyer A, Schöps P. Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain. BMJ. 2001 Jun 30;322(7302):1574-8. |
Week 10
|
|
Pressure pain threshold
Time Frame: Week 10
|
Pressure pain threshold measured at two individual points at the neck: (1) at the point of maximal pain and (2) in the adjacent region, one to two cm outside the painful area. Furthermore, it is measured bilaterally at levator scapulae muscle, semispinalis capitis muscle and trapezius muscle and at both hands, serving as control sites. Measurement procedure according to the protocol of QST. Reference: Rolke R et al.. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain 2006;123:231-243. |
Week 10
|
|
Neck disability index (NDI)
Time Frame: Week 10
|
The Neck Disability Index is an instrument to assess neck pain complaints.
Reference: Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity.
J Manipulative Physiol Ther 1991;14:409-415.
|
Week 10
|
|
SF-36
Time Frame: Week 10
|
The SF-36 is a short-form health survey consisting of 8 scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) measuring functional health and well-being as well as a physical a and mental health component scores. Reference: Bullinger M, Kirchberger I. SF-36 Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe, 1998. |
Week 10
|
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Pain diary
Time Frame: From Week 1 to Week 10
|
100mm visual analog scale for rating neck pain intensity each day
|
From Week 1 to Week 10
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-4358
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