Functional evaluation of surgery and exercise in the treatment of prolapsed intervertebral disc

ISRCTN	ISRCTN85530591
DOI	https://doi.org/10.1186/ISRCTN85530591
Secondary identifying numbers	D0571

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Trish Dolan
Scientific

Anatomy Department
University of Bristol
Southwell Street
Bristol
BS2 8EJ
United Kingdom

Phone	+44 (0)117 928 8363
Email	trish.dolan@bris.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	Not Applicable
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prolapsed intervertebral disc
Intervention	Patients randomised to the Exercise Group receive a 4 week postoperative exercise programme that begins 4 weeks after surgery. They attend the Physiotherapy Department at a local hospital for two 1-hour exercise classes per week over a period of 4 weeks. The classes involve some aerobic exercise but concentrate on exercises for strengthening and mobilising the trunk muscles such as back extension and flexion exercises. Classes are led by a physiotherapist but patients progress at their own pace. Attendance is recorded by the physiotherapist, and compliance with the exercise programme is monitored by means of weekly diary sheets kept by the patient and handed in at the end of the programme. Control group received care as usual.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1997
Completion date	01/01/1999

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Age between 18 and 65 years 2. Radiological evidence of disc protrusion in a position that correlates with the patient's signs and symptoms 3. Selection for decompression surgery
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1997
Date of final enrolment	01/01/1999

Anatomy Department

Bristol
BS2 8EJ
United Kingdom

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Charity

Arthritis Research Campaign (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	15/06/2000		Yes	No