search
Back to results

Effects of Hatha Yoga on Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hatha Yoga
Information regarding exercises and behaviour
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, yoga, proprioception, sensory thresholds, randomized controlled trial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hatha Yoga

Exercise information

Arm Description

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.

9 weeks of exercises practiced at home. Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients.

Outcomes

Primary Outcome Measures

Neck pain intensity (100mm visual analog scale)
100mm visual analog scale

Secondary Outcome Measures

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.
Active range of motion
6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left)
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.
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.
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.
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.
Pain diary
100mm visual analog scale for rating neck pain intensity each day

Full Information

First Posted
July 23, 2010
Last Updated
February 18, 2011
Sponsor
Universität Duisburg-Essen
search

1. Study Identification

Unique Protocol Identification Number
NCT01171274
Brief Title
Effects of Hatha Yoga on Chronic Neck Pain
Official Title
Randomisierte Kontrollierte Studie Zum Einfluss Von Hatha Yoga Auf Sensorische Schwellen, Kinästhetik Und Körperbild Bei Patienten Mit Chronischen Nackenschmerzen
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, yoga, proprioception, sensory thresholds, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hatha Yoga
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise information
Arm Type
Active Comparator
Arm Description
9 weeks of exercises practiced at home. Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients.
Intervention Type
Behavioral
Intervention Name(s)
Hatha Yoga
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Information regarding exercises and behaviour
Intervention Description
9 weeks of exercises practiced at home. Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients.
Primary Outcome Measure Information:
Title
Neck pain intensity (100mm visual analog scale)
Description
100mm visual analog scale
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Cervicocephalic kinesthetic sensibility
Description
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.
Time Frame
Week 10
Title
Active range of motion
Description
6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left)
Time Frame
Week 10
Title
Pain related to motion
Description
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.
Time Frame
Week 10
Title
Pressure pain threshold
Description
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.
Time Frame
Week 10
Title
Neck disability index (NDI)
Description
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.
Time Frame
Week 10
Title
SF-36
Description
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.
Time Frame
Week 10
Title
Pain diary
Description
100mm visual analog scale for rating neck pain intensity each day
Time Frame
From Week 1 to Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
City
Essen
State/Province
Northrhine-Westphalia
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Effects of Hatha Yoga on Chronic Neck Pain

We'll reach out to this number within 24 hrs