Randomised, controlled, multicenter, pilot study comparing qigong and back school for elderly patients with chronic neck pain
| ISRCTN | ISRCTN77101807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77101807 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/05/2006
- Registration date
- 23/05/2006
- Last edited
- 06/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Claudia Witt
Scientific
Scientific
Institute for Social Medicine
Charité University Medical Center
Berlin
10098
Germany
Study information
| Study design | Multicenter, three-armed, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | QIBANE |
| Study objectives | 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(s) | Yes, date of approval: 23/02/06; reference number: EA1/265/05 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 09/03/2006 |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 120 (40 per group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/03/2006 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Institute for Social Medicine
Berlin
10098
Germany
10098
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education
University/education
University Medical Center
Institute for Social Medicine
Berlin
10098
Germany
| Website | http://www.charite.de/epidemiologie |
|---|---|
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), Institute for Social Medicine, University Medical Center (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
