Neck Pain Clinical Trial
Official title:
Randomisierte Kontrollierte Studie Zum Einfluss Von Hatha Yoga Auf Sensorische Schwellen, Kinästhetik Und Körperbild Bei Patienten Mit Chronischen Nackenschmerzen
Verified date | February 2011 |
Source | Universität Duisburg-Essen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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. While studies have demonstrated benefits of Hatha Yoga for patients with chronic low back pain, no studies regarding chronic neck pain are available until now. The purpose of this study is to determine if Hatha Yoga can ameliorate chronic neck pain and related restrictions.
Status | Completed |
Enrollment | 58 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine | Essen | Northrhine-Westphalia |
Lead Sponsor | Collaborator |
---|---|
Universität Duisburg-Essen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neck pain intensity (100mm visual analog scale) | 100mm visual analog scale | Week 10 | No |
Secondary | Cervicocephalic kinesthetic sensibility | 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 | No |
Secondary | Active range of motion | 6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left) | Week 10 | No |
Secondary | Pain related to motion | 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 | No |
Secondary | Pressure pain threshold | 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 | No |
Secondary | Neck disability index (NDI) | 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 | No |
Secondary | SF-36 | 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 | No |
Secondary | Pain diary | 100mm visual analog scale for rating neck pain intensity each day | From Week 1 to Week 10 | No |
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