Neck PainNCT01171274
Effects of Hatha Yoga on Chronic Neck Pain
A study testing Hatha Yoga and Information regarding exercises and behaviour in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Hatha Yoga and Information regarding exercises and behaviour
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic mechanical neck pain, at least 40 mm on the 100mm visual analog scale.
- Pain for at least 3 months.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, North Rhine-Westphalia, 45276
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Hatha Yoga, Information regarding exercises and behaviour
- Keywords
- neck pain, yoga, proprioception, sensory thresholds, randomized controlled trial
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha YogaBehavioural
- 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 behaviourBehavioural
- 9 weeks of exercises practiced at home.
- Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients.
| Study group | Role | What they receive |
|---|---|---|
| Hatha Yoga | Active comparator | * 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. Receives: Behavioral: Hatha Yoga |
| Exercise information | Active comparator | * 9 weeks of exercises practiced at home.
* Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients. Receives: Behavioral: Information regarding exercises and behaviour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity (100mm visual analog scale)
100mm visual analog scale
Measured: Week 10
Secondary outcomes (7)
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.
Measured: Week 10
Active range of motion
6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left)
Measured: Week 10
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.
Measured: Week 10
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.
Measured: Week 10
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.
Measured: Week 10
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.
Measured: Week 10
Pain diary
100mm visual analog scale for rating neck pain intensity each day
Measured: From Week 1 to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171274
- Sponsor's protocol ID
- 10-4358
- Status last verified
- Feb 2011
- First submitted
- 23 Jul 2010
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisierte Kontrollierte Studie Zum Einfluss Von Hatha Yoga Auf Sensorische Schwellen, Kinästhetik Und Körperbild Bei Patienten Mit Chronischen Nackenschmerzen
- ClinicalTrials.gov ID
- NCT01171274
- Acronym / sponsor ID
- 10-4358
- Conditions
- Neck Pain
- Keywords
- neck pain, yoga, proprioception, sensory thresholds, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hatha Yoga | Active comparator | 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. |
| Exercise information | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic mechanical neck pain, at least 40 mm on the 100mm visual analog scale.
- Pain for at least 3 months.
Key exclusion criteria (8 listed)
- radicular symptoms
- congenital spine deformity
- pregnancy
- rheumatic diseases
- oncologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Hatha Yoga |
| 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. | Behavioural | Exercise information |
Primary outcome
Neck pain intensity (100mm visual analog scale)
Time frame: Week 10
100mm visual analog scale
7 secondary outcomes
Cervicocephalic kinesthetic sensibility
Time frame: Week 10
Active range of motion
Time frame: Week 10
Pain related to motion
Time frame: Week 10
Pressure pain threshold
Time frame: Week 10
Neck disability index (NDI)
Time frame: Week 10
SF-36
Time frame: Week 10
Pain diary
Time frame: From Week 1 to Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha Yoga and Information regarding exercises and behaviour in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain intensity (100mm visual analog scale) (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.