NCT02222051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

August 18, 2014

Last Update Submit

April 30, 2018

Conditions

Neck Pain

Keywords

neck painchronic pain

Outcome Measures

Primary Outcomes (1)

  • pain intensity

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

    week 12

Secondary Outcomes (13)

  • pain intensity

    week 24

  • pain on movement

    week 12, week 24

  • neck disability

    week 12, week 24

  • health related quality of life

    week 12, week 24

  • Anxiety and Depression

    week 12, week 24

  • +8 more secondary outcomes

Other Outcomes (1)

  • Experiences

    Week 24

Study Arms (3)

Tai Chi

EXPERIMENTAL

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

Behavioral: Tai Chi

Neck exercise

ACTIVE COMPARATOR

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

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

Interventions

Tai ChiBEHAVIORAL

traditional chinese martial art meditative movement technique

Also known as: Taiji, T'ai Chi
Tai Chi
Neck exercisesBEHAVIORAL

group exercises for strengthening and stretching neck and back muslces to alleviate neck pain

Also known as: neck training
Neck exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic non specific neck pain (3 months at least)
  • mm pain intensity on average on the visual analog scale

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

Location

Related Publications (3)

  • 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.

    PMID: 28146026BACKGROUND

  • 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.

    PMID: 27345663RESULT

  • Allende 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.

    PMID: 36930781DERIVED

MeSH Terms

Conditions

Neck PainChronic Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Gustav Dobos, Prof.

    Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 21, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

DE(1)