Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
24/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr J Skinner

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes