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Trial record 80 of 12444 for:    cervical

Tai Chi for Chronic Non-specific Neck Pain (TaiChiNe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02222051
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Romy Lauche, Universität Duisburg-Essen

Brief 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 group setting. Pain, Disability, quality of life, wellbeing, stress perception, psychological distress will be used to determine effects.

Condition or disease Intervention/treatment Phase
Neck Pain Behavioral: Tai Chi Behavioral: Neck exercises Not Applicable

Detailed Description:
see above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tai Chi for Chronic Non-specific Neck Pain: A Randomized Controlled Trial
Study Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tai Chi
Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes
Behavioral: Tai Chi
traditional chinese martial art meditative movement technique
Other Names:
  • Taiji
  • T'ai Chi

Active Comparator: Neck exercise
conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education
Behavioral: Neck exercises
group exercises for strengthening and stretching neck and back muslces to alleviate neck pain
Other Name: neck training

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



Primary Outcome Measures :
  1. pain intensity [ Time Frame: week 12 ]
    pain intensity on a visual analogue scale (0-100mm)


Secondary Outcome Measures :
  1. pain intensity [ Time Frame: week 24 ]
    pain intensity on a visual analogue scale (0-100mm)

  2. 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

  3. neck disability [ Time Frame: week 12, week 24 ]
    neck disability index (NDI), Vernon et al.

  4. health related quality of life [ Time Frame: week 12, week 24 ]
    short form quality of life questionnaire (SF-36), Bullinger and Kirchberger

  5. Anxiety and Depression [ Time Frame: week 12, week 24 ]
    Hospital Anxiety and Depression Scale (HADS)

  6. Wellbeing [ Time Frame: week 12, week 24 ]
    Wellbeing on the FEW16 Questionnaire

  7. Stress [ Time Frame: week 12, week 24 ]
    Subjective stress perception, Perceived Stress Scale (PSS)

  8. interoceptive awareness [ Time Frame: week 12, week 24 ]
    The Multidimensional Assessment of Interoceptive Awareness (MAIA)

  9. Postural Awareness [ Time Frame: week 12, week 24 ]
    Postural Awareness Questionnaire (PAS)

  10. Safety [ Time Frame: week 24 ]
    All adverse and serious adverse events

  11. pain intensity ratings [ Time Frame: week 12 ]
    daily rating of pain intensity, visual analog scales

  12. use of analgetics [ Time Frame: week 12 ]
    daily information on use of analgetics

  13. use of concomitant therapies [ Time Frame: week 12 ]
    daily information on use of concomitant therapies for neck pain


Other Outcome Measures:
  1. Experiences [ Time Frame: Week 24 ]
    Experiences with Tai Chi and neck exercises, qualitative interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222051


Locations
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Germany
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
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Principal Investigator: Gustav Dobos, Prof. Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Publications of Results:
Other Publications:
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Responsible Party: Romy Lauche, PhD, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02222051     History of Changes
Other Study ID Numbers: 13-5672 Tai Chi Neck Pain
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

Keywords provided by Romy Lauche, Universität Duisburg-Essen:
neck pain
chronic pain

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms