Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0209157425
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/02/2005
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
100 patients who are undergoing an elective total knee arthroscopy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant 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.
Recruitment start date
01/02/2005
Recruitment end date
31/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal National Orthopaedic Hospital (RNOHT)
Stanmore
HA7 4LP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal National Orthopaedic Hospital NHS Trust (UK) - NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list