Tai Chi for Chronic Non-specific Neck Pain

Study Overview
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Brief Summary
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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
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see above

Official Title
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Tai Chi for Chronic Non-specific Neck Pain: A Randomized Controlled Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Behavioral: Tai Chi
* Behavioral: Neck exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes | Behavioral: Tai Chi<br>* traditional chinese martial art meditative movement technique<br>* Other names: T'ai Chi;|
| Active Comparator: Neck exercise<br>conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education | Behavioral: Neck exercises<br>* group exercises for strengthening and stretching neck and back muslces to alleviate neck pain<br>* Other names: neck training;|
| No Intervention: Usual care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | pain intensity on a visual analogue scale (0-100mm) | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | pain intensity on a visual analogue scale (0-100mm) | 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 | week 12, week 24 | 
| neck disability | neck disability index (NDI), Vernon et al. | week 12, week 24 | 
| health related quality of life | short form quality of life questionnaire (SF-36), Bullinger and Kirchberger | week 12, week 24 | 
| Anxiety and Depression | Hospital Anxiety and Depression Scale (HADS) | week 12, week 24 | 
| Wellbeing | Wellbeing on the FEW16 Questionnaire | week 12, week 24 | 
| Stress | Subjective stress perception, Perceived Stress Scale (PSS) | week 12, week 24 | 
| interoceptive awareness | The Multidimensional Assessment of Interoceptive Awareness (MAIA) | week 12, week 24 | 
| Postural Awareness | Postural Awareness Questionnaire (PAS) | week 12, week 24 | 
| Safety | All adverse and serious adverse events | week 24 | 
| pain intensity ratings | daily rating of pain intensity, visual analog scales | week 12 | 
| use of analgetics | daily information on use of analgetics | week 12 | 
| use of concomitant therapies | daily information on use of concomitant therapies for neck pain | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, chronic pain