Randomised controlled study of the use of electrical muscle stimulation in elective total knee arthroscopy
| ISRCTN | ISRCTN36684174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36684174 |
| Protocol serial number | N0209157425 |
| Sponsor | Department of Health |
| Funder | Royal National Orthopaedic Hospital NHS Trust (UK) - NHS R&D Support Funding |
- 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 of protocol
Not provided at time of registration
Contact information
Mr J Skinner
Scientific
Scientific
Royal National Orthopaedic Hospital (RNOHT)
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Time to actively raise the straight leg after operation |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal National Orthopaedic Hospital (RNOHT)
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/02/2020: No publications found, verifying study status with the principal investigator.
