Randomised controlled study of the use of electrical muscle stimulation in elective total knee arthroscopy

ISRCTN	ISRCTN36684174
DOI	https://doi.org/10.1186/ISRCTN36684174
Secondary identifying numbers	N0209157425

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

Mr J Skinner
Scientific

Royal National Orthopaedic Hospital (RNOHT)
Brockley Hill
Stanmore
HA7 4LP
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	-
Study objectives	Patients undergoing total knee arthroscopy develop thigh muscle weakness before and after surgery. Recovery from the operation depends on straight leg raise, walking, movement of the knee joint & stair walking, which all require good muscle power/strength. Electrical muscle stimulation has been shown to be effective in preventing the decrease in muscle strength, muscle mass and oxidative capacity of thigh muscles following knee immobilisation. This study will look a the effect of stimulating the quadracepts and hamstring muscles, to see if it results in improved straight leg raise and flexion of the knee after operation. Effects on pain, muscle size and length of hospital stay will also be examined.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Total knee arthroscopy
Intervention	Patients in the treatment group (50) self-administer daily electrical muscle stimulation for 6-weeks prior to surgery.
Intervention type	Procedure/Surgery
Primary outcome measure	Time to actively raise the straight leg after operation Degree of leg flex 5 days post surgery
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/2005
Completion date	31/07/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	100
Key inclusion criteria	100 patients who are undergoing an elective total knee arthroscopy
Key exclusion criteria	1. Revision operations 2. People taking aspirin, clopidogrel or warfarin 3. Patients with bleeding disorders, pace maker, unstable/serious cardiac arrhythmia 4. Patients with dementia, seizure disorders 5. Patients with diabetes or multiple sclerosis, patients with skin disorders, sensitive skin or scars at site of stimulation.
Date of first enrolment	01/02/2005
Date of final enrolment	31/07/2005

Royal National Orthopaedic Hospital (RNOHT)

Stanmore
HA7 4LP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal National Orthopaedic Hospital NHS Trust (UK) - NHS R&D Support Funding

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

20/02/2020: No publications found, verifying study status with the principal investigator.