Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/10/2011
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

Dr Michael Callaghan

ORCID ID

Contact details

Clinical Specialist & Research Associate
Centre for Rehabilitation Science
ARC Epidemiology Unit
School of Translational Medicine
University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom
+44 0161 306 0542
michael.callaghan@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0453162803

Study information

Scientific title

Acronym

Study hypothesis

The principle objective is to discover if there is any increase in brain activity when subjects perform a simple proprioceptive test with and without a piece of tape across the knee cap.

Ethics approval

Added June 2008: approved by Salford and Trafford LREC, ref 05/Q1404/17.

Study design

Pilot RCT

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Knee

Intervention

The subjects will lie in the scanner wearing shorts. A plastic block will support the thigh and knee at an angle of 45 degrees of knee inflexion. A strap will be placed over the hips to further limit head motion as a consequence of lower limb motion. Every effort will be made to control head movement by using a foam pad velcro strap and a bite bar. To ensure minimum ankle, foot and toe movements during the test, these joints will be placed in a neutral position and held by a temporary plaster cast and velcro straps.

MR scanning using the BOLD technique will be performed using a 1.5 tesla machine. The scanning protocol will be based on a functional time series. Each time series will consist of 4 blocks of 4 conditions: knee joint extension to 0deg, extension to 20deg with or without patellar tape. Each condition will last 5 minutes consisting of 30 sec on (ie the task) and 30 sec off (no task) and will be triggered by an auditory command given by using headphones customised for fMRI experiments. A metronome will pace the movements using sound in order to impose a constant timing and equal no of cycles across conditions.

Patellar taping will then be applied. The order of tape/no tape will be randomised

The acquired images will be assessed carefully for head movement and in order to correct the confounding effects induced by head movement realignment parameters. To process the data, statistical parametric mapping will be used to display the significance of activation and to analyse functional and anatomical image. SPM is the most prevalent approach to characterising activity related changes (Friston et al 2000).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Neural processing in the brain as a result of application of patellar tape detected by the BOLD technique using fMRI.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

26/04/2005

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

8 healthy volunteers between the ages of 20-40 years will have refrained from any physical exercise for 3 days prior to the testing. They will sign a consent form after reading the study information sheet and after having had the opportunity to ask questions about any aspect of the study and their role.
There is no control group. All subjects will act as their own internal controls.

Participant type

Healthy volunteer

Age group

Adult

Gender

Not Specified

Target number of participants

8 healthy volunteers

Participant exclusion criteria

Added June 2008:
1. Histories of neurological or cardiovascular disease
2. Cochlear implants or any metal objects in the body
3. Cardiac or neural pacemakers
4. Histories of serious musculoskeletal injury in both lower limbs

Recruitment start date

26/04/2005

Recruitment end date

31/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Specialist & Research Associate
Manchester
M13 9PT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Presented at the Annual Congress of the Chartered Society of Physiotherapy October 2008

Publication citations

Additional files

Editorial Notes