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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tai Chi
Neck exercises
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Tai Chi

Neck exercise

Usual care

Arm Description

Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes

conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education

Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study

Outcomes

Primary Outcome Measures

pain intensity
pain intensity on a visual analogue scale (0-100mm)

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2014
Last Updated
April 30, 2018
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT02222051
Brief Title
Tai Chi for Chronic Non-specific Neck Pain
Acronym
TaiChiNe
Official Title
Tai Chi for Chronic Non-specific Neck Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes
Arm Title
Neck exercise
Arm Type
Active Comparator
Arm Description
conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Other Intervention Name(s)
Taiji, T'ai Chi
Intervention Description
traditional chinese martial art meditative movement technique
Intervention Type
Behavioral
Intervention Name(s)
Neck exercises
Other Intervention Name(s)
neck training
Intervention Description
group exercises for strengthening and stretching neck and back muslces to alleviate neck pain
Primary Outcome Measure Information:
Title
pain intensity
Description
pain intensity on a visual analogue scale (0-100mm)
Time Frame
week 12
Secondary Outcome Measure Information:
Title
pain intensity
Description
pain intensity on a visual analogue scale (0-100mm)
Time Frame
week 24
Title
pain on movement
Description
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
Time Frame
week 12, week 24
Title
neck disability
Description
neck disability index (NDI), Vernon et al.
Time Frame
week 12, week 24
Title
health related quality of life
Description
short form quality of life questionnaire (SF-36), Bullinger and Kirchberger
Time Frame
week 12, week 24
Title
Anxiety and Depression
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
week 12, week 24
Title
Wellbeing
Description
Wellbeing on the FEW16 Questionnaire
Time Frame
week 12, week 24
Title
Stress
Description
Subjective stress perception, Perceived Stress Scale (PSS)
Time Frame
week 12, week 24
Title
interoceptive awareness
Description
The Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time Frame
week 12, week 24
Title
Postural Awareness
Description
Postural Awareness Questionnaire (PAS)
Time Frame
week 12, week 24
Title
Safety
Description
All adverse and serious adverse events
Time Frame
week 24
Title
pain intensity ratings
Description
daily rating of pain intensity, visual analog scales
Time Frame
week 12
Title
use of analgetics
Description
daily information on use of analgetics
Time Frame
week 12
Title
use of concomitant therapies
Description
daily information on use of concomitant therapies for neck pain
Time Frame
week 12
Other Pre-specified Outcome Measures:
Title
Experiences
Description
Experiences with Tai Chi and neck exercises, qualitative interviews
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof.
Organizational Affiliation
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
City
Essen
State/Province
NRW
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28146026
Citation
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.
Results Reference
background
PubMed Identifier
27345663
Citation
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.
Results Reference
result

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Tai Chi for Chronic Non-specific Neck Pain

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