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
Protocol serial number	N/A
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), Institute for Social Medicine, University Medical Center (Germany)

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

Dr Claudia Witt
Scientific

Institute for Social Medicine
Charité University Medical Center
Berlin
10098
Germany

Primary study design	Interventional
Study design	Multicenter, three-armed, randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Pain measured on the VAS (visual analogue scale) after three months
Key secondary outcome measure(s)	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)
Completion date	31/10/2006

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	120
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

Institute for Social Medicine

Berlin
10098
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan