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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01171274
Other study ID # 10-4358
Secondary ID
Status Completed
Phase N/A
First received July 23, 2010
Last updated February 18, 2011
Start date August 2010
Est. completion date December 2010

Study information

Verified date February 2011
Source Universität Duisburg-Essen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Hatha Yoga
9 weeks of Hatha Yoga, designed for treating chronic neck pain, as a group intervention. One class of 90 minutes per week, 10 minutes training at home each day.
Information regarding exercises and behaviour
9 weeks of exercises practiced at home. Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients.

Locations

Country Name City State
Germany Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine Essen Northrhine-Westphalia

Sponsors (1)

Lead Sponsor Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

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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