Is the McKenzie system in physiotherapy more effective than a Brief Intervention in helping patients cope with their back or neck pain?

ISRCTN	ISRCTN48919562
DOI	https://doi.org/10.1186/ISRCTN48919562
Protocol serial number	K0572
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jennifer Klaber Moffett
Scientific

Institute of Rehabilitation
University of Hull
215 Anlaby Road
Hull
HU3 2PG
United Kingdom

Phone	+44 (0)1482 675610

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	McKABI
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Back pain and neck pain
Intervention	Patients randomised to the McKenzie group will be allocated to a McKenzie trained physiotherapist. Patients randomised to the Brief Intervention group based on cognitive¿behavioural principles. It will consist of a brief assessment and physical examination to exclude any serious pathology, helping the patient to identify specific problems and work out solutions using a patient education booklet, and encouraging movement and appropriate paced exercises.
Intervention type	Other
Primary outcome measure(s)	Tampa Scale of Kinesiophobia
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/08/2006

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	315
Key inclusion criteria	1. Sub-acute or chronic neck and back pain of mechanical origin (lasting at least 3 weeks) 2. Able to travel independently to the physiotherapy department 3. Age range at least 18 years (no upper limit). The aim is to be as inclusive as possible in order to improve generalisability and clinical relevance of the findings.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/08/2002
Date of final enrolment	30/08/2006

Institute of Rehabilitation

Hull
HU3 2PG
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	01/12/2006		Yes	No