Effects of Hatha Yoga on Chronic Neck Pain

This study has been completed.

Sponsor:

Information provided by:

Universität Duisburg-Essen

ClinicalTrials.gov Identifier:

NCT01171274

First received: July 23, 2010

Last updated: February 18, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 23, 2010
Last Updated Date	February 18, 2011
Start Date ^ICMJE	August 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 23, 2010)	Neck pain intensity (100mm visual analog scale) [ Time Frame: Week 10 ] [ Designated as safety issue: No ] 100mm visual analog scale
Original Primary Outcome Measures ^ICMJE (submitted: July 27, 2010)	Neck pain intensity (100mm visual analog scale) [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01171274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 23, 2010)	Cervicocephalic kinesthetic sensibility [ Time Frame: Week 10 ] [ Designated as safety issue: No ] 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. Active range of motion [ Time Frame: Week 10 ] [ Designated as safety issue: No ] 6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left) Pain related to motion [ Time Frame: Week 10 ] [ Designated as safety issue: No ] 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. Pressure pain threshold [ Time Frame: Week 10 ] [ Designated as safety issue: No ] 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. Neck disability index (NDI) [ Time Frame: Week 10 ] [ Designated as safety issue: No ] 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. SF-36 [ Time Frame: Week 10 ] [ Designated as safety issue: No ] 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. Pain diary [ Time Frame: From Week 1 to Week 10 ] [ Designated as safety issue: No ] 100mm visual analog scale for rating neck pain intensity each day
Original Secondary Outcome Measures ^ICMJE (submitted: July 27, 2010)	Cervicocephalic kinesthetic sensibility [ Time Frame: Week 11 ] [ Designated as safety issue: No ] 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. Active range of motion [ Time Frame: Week 11 ] [ Designated as safety issue: No ] 6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left) Pain related to motion [ Time Frame: Week 11 ] [ Designated as safety issue: No ] 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. Pressure pain threshold [ Time Frame: Week 11 ] [ Designated as safety issue: No ] Pressure pain threshold measured at two 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 and at two control areas apart from the painful area, the right hand and foot. 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. Mechanical detection threshold [ Time Frame: Week 11 ] [ Designated as safety issue: No ] Mechanical detection threshold measured at two 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 and at two control areas apart from the painful area, the right hand and foot. 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. Vibration detection threshold [ Time Frame: Week 11 ] [ Designated as safety issue: No ] Vibration detection threshold measured at two 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 and at two control areas apart from the painful area, the right hand and foot. 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. Pain diary [ Time Frame: From week 1 to week 11 ] [ Designated as safety issue: No ] 100mm visual analog scale for rating neck pain intensity each day Neck disability index (NDI) [ Time Frame: Week 11 ] [ Designated as safety issue: No ] 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. SF-36 [ Time Frame: Week 11 ] [ Designated as safety issue: No ] 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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Hatha Yoga on Chronic Neck Pain
Official Title ^ICMJE	Randomisierte Kontrollierte Studie Zum Einfluss Von Hatha Yoga Auf Sensorische Schwellen, Kinästhetik Und Körperbild Bei Patienten Mit Chronischen Nackenschmerzen
Brief 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.
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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Neck Pain
Intervention ^ICMJE	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. Behavioral: 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.
Study Arm (s)	Active Comparator: 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. Intervention: Behavioral: Hatha Yoga Active Comparator: Exercise information 9 weeks of exercises practiced at home. Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients. Intervention: Behavioral: Information regarding exercises and behaviour
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	58
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01171274
Other Study ID Numbers ^ICMJE	10-4358
Has Data Monitoring Committee	No
Responsible Party	Gustav J Dobos, MD, Universität Duisburg Essen, Chair of Complementary and Integrative Medicine
Study Sponsor ^ICMJE	Universität Duisburg-Essen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Universität Duisburg-Essen
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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