NCT00615732

Brief Summary

The purpose of this study is to assess the effectiveness of qigong for the treatment of chronic neck pain compared to exercise therapy and waiting list group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

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

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

February 1, 2008

Last Update Submit

July 9, 2012

Conditions

Chronic Neck Pain

Keywords

qigongtraditional chinese medicineexercise therapyneck pain

Outcome Measures

Primary Outcomes (1)

  • average pain intensity during the last 7 days measured on a visual analogue scale (VAS)

    baseline, 3, 6, 12, and 24 months

Secondary Outcomes (6)

  • Neck Pain and Disability Scale (NPAD, Wheeler 1999)

    baseline, 3, 6, 12, and 24 months

  • health related quality of life (SF-36)

    baseline, 3, 6, 12 and 24 months

  • patient expectation and self efficacy (questionnaire)

    Baseline, 3, 6, 12, and 24 months

  • therapist's expectation

    baseline, 3, 6, 12, and 24 months

  • undesired effects

    3, 6, 12, and 24 months

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

qigong

Procedure: Qigong

2

ACTIVE COMPARATOR

exercise therapy

Procedure: exercise therapy

3

NO INTERVENTION

Interventions

QigongPROCEDURE

18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week

1
exercise therapyPROCEDURE

18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week

2

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of chronic neck pain since at least 6 months and complaints for a maximum duration of 5 years
  • neck pain more prominent than other pain in the spine
  • average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
  • normal mobility of the cervical spine
  • intellectual and physical ability to participate in the study
  • informed consent

You may not qualify if:

  • cervical pain related to malignancy
  • cervical pain due to an accident
  • inflammatory joint disorders
  • previous spine surgery
  • protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
  • actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
  • use of pain drugs for other diseases (\> 1x/week)
  • pregnancy
  • severe chronic or acute disease interfering with therapy attendance
  • alcohol or substance abuse
  • participation in another clinical trial in the last 6 months before study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Berlin, 10117, Germany

Location

Related Publications (1)

  • Rendant D, Pach D, Ludtke R, Reisshauer A, Mietzner A, Willich SN, Witt CM. Qigong versus exercise versus no therapy for patients with chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2011 Mar 15;36(6):419-27. doi: 10.1097/BRS.0b013e3181d51fca.

    PMID: 21178832RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

QigongExercise Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Claudia M Witt, MD

    Charite University, Berlin, Germany

    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
Prof. Dr. med.

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2009

Study Completion

October 1, 2009

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

DE(1)