A Pilot Study Comparing Frequency and Style of Acupuncture for Chronic Low Back Pain

ISRCTN	ISRCTN41571810
DOI	https://doi.org/10.1186/ISRCTN41571810
Protocol serial number	1
Sponsor	University of Ulster (UK)
Funder	University of Ulster (UK) - Vice Chancellor Scholarship (VCRS)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Suzanne McDonough
Scientific

14J15, Rehabilitation Sciences Research Institute
University of Ulster
Shore Road
Newtown Abbey
County Antrim
BT37 0QB
United Kingdom

Phone	+44 (0)28 90 366459
Email	S.McDonough@ulster.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ACLBP
Study objectives	1. To compare the effectiveness of traditional chinese acupuncture, based on traditional Chinese medical (TCM) diagnosis, with moxibustion/cupping if necessary, with Western acupuncture based on Western diagnosis, without moxibustion/cupping, for chronic non-specific chronic low back pain 2. To explore whether intensive acupuncture treatment frequencies i.e. 5 treatments/week can achieve better treatment effects than 2 treatments/week, for non-specific low back pain
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Non-specific low back pain
Intervention	1. Traditional Chinese acupuncture (with moxibustion and cupping if necessary) 2. Western acupuncture
Intervention type	Other
Primary outcome measure(s)	Visual analogue scale (VAS)
Key secondary outcome measure(s)	1. Functional disability 2. Quality of life 3. Psychological impact 4. Shuttle walk test 5. Lateral trunk flexibility
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Non-specific acute or chronic low back pain (LBP) as the chief complaint, with or without leg pain 2. Age between 18-60 years and of both genders
Key exclusion criteria	1. History of disc or spine surgery 2. Sciatica 3. Neurological disorders and possible serious pathological back problem 4. Systemic bone or joint disorders (e.g. rheumatoid arthritis) 5. Pregnancy 6. Dementia 7. Severe clotting disorders or anticoagulant therapy 8. Epilepsy 9. Systemic or visceral disease 10. Current use of systemic corticosteroids, muscle relaxants, narcotic medications 11. Overt psychiatric illness 12. Receiving acupuncture treatment within the past 6 months 13. Unemployment or having current pending compensation claims 14. Other acute orthopaedic or medical problems
Date of first enrolment	01/09/2005
Date of final enrolment	01/12/2005

14J15, Rehabilitation Sciences Research Institute

County Antrim
BT37 0QB
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No