Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/05/2006
Date assigned
23/05/2006
Last edited
06/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claudia Witt

ORCID ID

Contact details

Institute for Social Medicine
Charité University Medical Center
Berlin
10098
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

QIBANE

Study hypothesis

Primary hypothesis: there is a significant difference between the qigong and the waiting list groups for the primary outcome (visual analogue scale [VAS]) after 3 months.
Secondary hypothesis: there is a significant difference between the qigong and the back school groups for the primary outcome (VAS) after 3 months.

Ethics approval

Yes, date of approval: 23/02/06; reference number: EA1/265/05

Study design

Multicenter, three-armed, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic neck pain

Intervention

Patients are randomized into the qigong and back school exercise groups (each 24 sessions of 45 min over a period of three months)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain measured on the VAS (visual analogue scale) after three months

Secondary outcome measures

1. Neck pain (Neck Pain and Disability Scale, Wheeler)
2. Depression (Depression Scale, Hautzinger)
3. Quality of life (Short-form Questionnaire-36 [SF-36], Bullinger)
4. Frequency of falls and anxiety to fall
5. Sleep quality and satisfaction
6. Overall treatment effect (OTE) (Wiklund)

Overall trial start date

09/03/2006

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥55 years of age
2. Chronic neck pain (duration >6 months)
3. Average pain during the last 7 days before randomisation ≥20 mm on 100 mm VAS
4. Informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

120 (40 per group)

Participant exclusion criteria

1. Serious acute or chronic disease which would not allow the exercises to be performed
2. Planned start of physiotherapy for chronic neck pain during study participation
3. Participation in another study during the last 6 months before study entry

Recruitment start date

09/03/2006

Recruitment end date

31/10/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Institute for Social Medicine
Berlin
10098
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

University Medical Center
Institute for Social Medicine
Berlin
10098
Germany

Sponsor type

University/education

Website

http://www.charite.de/epidemiologie

Funders

Funder type

University/education

Funder name

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), Institute for Social Medicine, University Medical Center (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes