Neck PainTaiChiNeNCT02222051
Tai Chi for Chronic Non-specific Neck Pain
A study testing Tai Chi and Neck exercises in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Tai Chi and Neck exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic non specific neck pain (3 months at least)
- 45mm pain intensity on average on the visual analog scale
Who cannot join
- specific neck pain due to
- inflammatory diseases
- rheumatic diseases
- neurological diseases
- prolapse or protrusion
- oncological disease
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45276
About this study
Official title: 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.
Read the detailed description
see above
- Conditions
- Neck Pain
- Being tested
- Tai Chi, Neck exercises
- Keywords
- neck pain, chronic pain
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Also called Taiji, T'ai Chi
traditional chinese martial art meditative movement technique
Neck exercisesBehavioural
Also called neck training
group exercises for strengthening and stretching neck and back muslces to alleviate neck pain
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes Receives: Behavioral: Tai Chi |
| Neck exercise | Active comparator | conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education Receives: Behavioral: Neck exercises |
| Usual care | No intervention | Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain intensity on a visual analogue scale (0-100mm)
Measured: week 12
Secondary outcomes (13)
pain intensity
pain intensity on a visual analogue scale (0-100mm)
Measured: week 24
pain on movement
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
Measured: week 12, week 24
neck disability
neck disability index (NDI), Vernon et al.
Measured: week 12, week 24
health related quality of life
short form quality of life questionnaire (SF-36), Bullinger and Kirchberger
Measured: week 12, week 24
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS)
Measured: week 12, week 24
Wellbeing
Wellbeing on the FEW16 Questionnaire
Measured: week 12, week 24
Stress
Subjective stress perception, Perceived Stress Scale (PSS)
Measured: week 12, week 24
interoceptive awareness
The Multidimensional Assessment of Interoceptive Awareness (MAIA)
Measured: week 12, week 24
Postural Awareness
Postural Awareness Questionnaire (PAS)
Measured: week 12, week 24
Safety
All adverse and serious adverse events
Measured: week 24
pain intensity ratings
daily rating of pain intensity, visual analog scales
Measured: week 12
use of analgetics
daily information on use of analgetics
Measured: week 12
use of concomitant therapies
daily information on use of concomitant therapies for neck pain
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof., Principal investigator, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222051
- Sponsor's protocol ID
- 13-5672 Tai Chi Neck Pain
- Acronym
- TaiChiNe
- Status last verified
- Apr 2018
- First submitted
- 18 Aug 2014
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28146026Lauche 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.
PubMed 27345663Allende S, Cramer H, Wayne P, Lauche R. Investigating Inter- and Intra-individual Differences in Tai Chi Practice Time, Pain, and Mood Among Participants with Chronic Nonspecific Neck Pain: Secondary Analysis of a Randomized Controlled Trial. J Integr Complement Med. 2023 Apr;29(4):234-240. doi: 10.1089/jicm.2022.0789. Epub 2023 Mar 17.
PubMed 36930781
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi for Chronic Non-specific Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02222051
- Acronym / sponsor ID
- TaiChiNe / 13-5672 Tai Chi Neck Pain
- Conditions
- Neck Pain
- Keywords
- neck pain, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Aug 2014 (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.
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.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiSimplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes |
| Neck exercise | Active comparator | Behavioral: Neck exercisesconventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education |
| Usual care | No intervention | –Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic non specific neck pain (3 months at least)
- 45mm pain intensity on average on the visual analog scale
Key exclusion criteria (13 listed)
- specific neck pain due to
- inflammatory diseases
- rheumatic diseases
- neurological diseases
- prolapse or protrusion
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 |
|---|---|---|
| Tai ChiAlso: Taiji, T'ai Chitraditional chinese martial art meditative movement technique | Behavioural | Tai Chi |
| Neck exercisesAlso: neck traininggroup exercises for strengthening and stretching neck and back muslces to alleviate neck pain | Behavioural | Neck exercise |
Primary outcome
pain intensity
Time frame: week 12
pain intensity on a visual analogue scale (0-100mm)
13 secondary outcomes
pain intensity
Time frame: week 24
pain on movement
Time frame: week 12, week 24
neck disability
Time frame: week 12, week 24
health related quality of life
Time frame: week 12, week 24
Anxiety and Depression
Time frame: week 12, week 24
Wellbeing
Time frame: week 12, week 24
Stress
Time frame: week 12, week 24
interoceptive awareness
Time frame: week 12, week 24
Postural Awareness
Time frame: week 12, week 24
Safety
Time frame: week 24
pain intensity ratings
Time frame: week 12
use of analgetics
Time frame: week 12
use of concomitant therapies
Time frame: week 12
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 2 May 2018.
- Background: PubMed 28146026Lauche 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.
- Results publication: PubMed 27345663Lauche 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.
- Derived from this study: PubMed 36930781Allende S, Cramer H, Wayne P, Lauche R. Investigating Inter- and Intra-individual Differences in Tai Chi Practice Time, Pain, and Mood Among Participants with Chronic Nonspecific Neck Pain: Secondary Analysis of a Randomized Controlled Trial. J Integr Complement Med. 2023 Apr;29(4):234-240. doi: 10.1089/jicm.2022.0789. Epub 2023 Mar 17.
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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.
Gustav Dobos, Prof. principal investigator
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Neck exercises 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 13 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 2 May 2018. 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?
pain intensity (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02222051, which also lists 3 linked publications.
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 2 May 2018.