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
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
20/02/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Mr J Skinner
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title-
Study hypothesisPatients 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
ConditionTotal knee arthroscopy
InterventionPatients in the treatment group (50) self-administer daily electrical muscle stimulation for 6-weeks prior to surgery.
Intervention typeProcedure/Surgery
Primary outcome measureTime to actively raise the straight leg after operation
Degree of leg flex 5 days post surgery
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/2005
Overall study end date31/07/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Participant inclusion criteria100 patients who are undergoing an elective total knee arthroscopy
Participant exclusion criteria1. 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 date01/02/2005
Recruitment end date31/07/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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