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

July 23, 2010
February 18, 2011
August 2010
December 2010   (final data collection date for primary outcome measure)
Neck pain intensity (100mm visual analog scale) [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
100mm visual analog scale
Neck pain intensity (100mm visual analog scale) [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01171274 on ClinicalTrials.gov Archive Site
  • 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
  • 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.

Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Neck Pain
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01171274
10-4358
No
Gustav J Dobos, MD, Universität Duisburg Essen, Chair of Complementary and Integrative Medicine
Universität Duisburg-Essen
Not Provided
Not Provided
Universität Duisburg-Essen
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP