- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222051
Tai Chi for Chronic Non-specific Neck Pain (TaiChiNe)
April 30, 2018 updated by: Romy Lauche, Universität Duisburg-Essen
Tai Chi for Chronic Non-specific Neck Pain: A Randomized Controlled Trial
In this study the efficacy of Tai Chi will be tested in comparison to conventional neck exercises and usual care in a randomized controlled trial.
Tai Chi and neck exercises will be lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks of training, once weekly for 60-90 min in a group setting.
Pain, Disability, quality of life, wellbeing, stress perception, psychological distress will be used to determine effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
see above
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Essen, NRW, Germany, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic non specific neck pain (3 months at least)
- 45mm pain intensity on average on the visual analog scale
Exclusion Criteria:
- specific neck pain due to
- inflammatory diseases
- rheumatic diseases
- neurological diseases
- prolapse or protrusion
- oncological disease
- trauma (whiplash)
- congenital deformity of the spine
- severe comorbidity (somatic, psychiatric)
- pregnancy
- participation in other clinical trials
- regular practice of tai chi, qigong, yoga in the past 6 months
- medication with opioids
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai Chi
Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes
|
traditional chinese martial art meditative movement technique
Other Names:
|
Active Comparator: Neck exercise
conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education
|
group exercises for strengthening and stretching neck and back muslces to alleviate neck pain
Other Names:
|
No Intervention: Usual care
Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: week 12
|
pain intensity on a visual analogue scale (0-100mm)
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: week 24
|
pain intensity on a visual analogue scale (0-100mm)
|
week 24
|
pain on movement
Time Frame: week 12, week 24
|
pain intensity on a visual analogue scale (0-100mm) evoked by head movement into 6 directions POM validated by Lauche et al., 2014, Pain Medicine
|
week 12, week 24
|
neck disability
Time Frame: week 12, week 24
|
neck disability index (NDI), Vernon et al.
|
week 12, week 24
|
health related quality of life
Time Frame: week 12, week 24
|
short form quality of life questionnaire (SF-36), Bullinger and Kirchberger
|
week 12, week 24
|
Anxiety and Depression
Time Frame: week 12, week 24
|
Hospital Anxiety and Depression Scale (HADS)
|
week 12, week 24
|
Wellbeing
Time Frame: week 12, week 24
|
Wellbeing on the FEW16 Questionnaire
|
week 12, week 24
|
Stress
Time Frame: week 12, week 24
|
Subjective stress perception, Perceived Stress Scale (PSS)
|
week 12, week 24
|
interoceptive awareness
Time Frame: week 12, week 24
|
The Multidimensional Assessment of Interoceptive Awareness (MAIA)
|
week 12, week 24
|
Postural Awareness
Time Frame: week 12, week 24
|
Postural Awareness Questionnaire (PAS)
|
week 12, week 24
|
Safety
Time Frame: week 24
|
All adverse and serious adverse events
|
week 24
|
pain intensity ratings
Time Frame: week 12
|
daily rating of pain intensity, visual analog scales
|
week 12
|
use of analgetics
Time Frame: week 12
|
daily information on use of analgetics
|
week 12
|
use of concomitant therapies
Time Frame: week 12
|
daily information on use of concomitant therapies for neck pain
|
week 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experiences
Time Frame: Week 24
|
Experiences with Tai Chi and neck exercises, qualitative interviews
|
Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gustav Dobos, Prof., Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lauche R, Wayne PM, Fehr J, Stumpe C, Dobos G, Cramer H. Does Postural Awareness Contribute to Exercise-Induced Improvements in Neck Pain Intensity? A Secondary Analysis of a Randomized Controlled Trial Evaluating Tai Chi and Neck Exercises. Spine (Phila Pa 1976). 2017 Aug 15;42(16):1195-1200. doi: 10.1097/BRS.0000000000002078.
- Lauche R, Stumpe C, Fehr J, Cramer H, Cheng YW, Wayne PM, Rampp T, Langhorst J, Dobos G. The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. J Pain. 2016 Sep;17(9):1013-27. doi: 10.1016/j.jpain.2016.06.004. Epub 2016 Jun 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
August 18, 2014
First Submitted That Met QC Criteria
August 20, 2014
First Posted (Estimate)
August 21, 2014
Study Record Updates
Last Update Posted (Actual)
May 2, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-5672 Tai Chi Neck Pain
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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