Patellar taping will reduce pain but will not provide any measurable changes in patellar position from MRI data or from the caliper

ISRCTN ISRCTN96689245
DOI https://doi.org/10.1186/ISRCTN96689245
Secondary identifying numbers N/A
Submission date
22/10/2015
Registration date
16/11/2015
Last edited
15/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The knee is the largest weight-bearing joint in the body. It is a complex joint where the shin bone (tibia) and thigh bone (femur) meet creating a “hinge”. The kneecap (patella) is a small, triangular shaped bone located in front of the knee joint. It is very important that the patella is in the correct position, as it plays a vital role in helping to bend (flexion) the knee by acting as a “pulley” for the thigh (quadriceps) muscle. Patellar mal-alignment, also known as patellofemoral pain is a common condition in which the patellar does not aligned properly. Normally, when the knee bends, the patellar moves in a small groove in the femur (femoral groove). When the patella is not lined up with this groove, it can travel more to the side, making it rub against the femur. This causes the knee to become overloaded with pressure causing pain when bending the knee. A common treatment for patellar mal-alignment is taping the knee to support the patella (McConnell taping technique). This works by applying the tape to the skin to reposition the patella relative to the femur when the knee is bent up to 30° (30° flexion). It has been found that many patients experience a reduction in pain after this taping is applied, however more research is needed to find out if the tape is actually managing to realign the patella. The aim of this study is to find out whether the McConnell taping technique can realign the position of the patella in an MRI scanner and with a calliper, and whether this will lead to reduced pain during squat activities.

Who can participate?
Adults with pain at the front and center of the knee with patellar mal-alignment.

What does the study involve?
All participants begin the study by having measurements taken of their leg in order to look at the position of the patella when the knee is bent at 30°, using MRI scanning and a custom built calliper (device for measuring distance). They are also asked to complete squatting exercises so that their levels of pain can be measured. These measurements are then repeated in order to ensure that the measurements are valid. Participants are then randomly allocated to one of two groups. Those in the first group have their knee taped using the McConnell taping technique, to support the patella in the correct position. Those in the second group have placebo (dummy) taping applied, which is not designed to have any effect on their patella positioning. For all participants, the tape is worn for about 20 minutes so the measurements of patella position and pain can be repeated. Those in the corrective taping group will then have the placebo taping applied, and those in the placebo group will have the corrective taping applied.

What are the possible benefits and risks of participating?
Participants may benefit from a reduction in pain from the taping. This could help to find better treatments for that individual in future. There are no notable risks of taking part, although participants may feel pain when they are completing the squatting exercises.

Where is the study run from?
London Sports Orthopaedics (UK)

When is the study starting and how long is it expected to run for?
January 2016 to April 2018

Who is funding the study?
1. Buckinghamshire New University (UK)
2. Brunel University London (UK)

Who is the main contact?
Mr Kevin Campbell-Karn
kevin.campbell-karn@bucks.ac.uk

Contact information

Mr Kevin Campbell-Karn
Scientific

Buckinghamshire New University
Queen Alexandra Road
High Wycombe
HP11 2JZ
United Kingdom

ORCiD logoORCID ID 0000-0003-4129-7499
Phone +44 (0)1494 522141 (x3265)
Email kevin.campbell-karn@bucks.ac.uk

Study information

Study designSingle-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffects of taping on MRI and a novel caliper measuring patellar mal-alignment and subjective perception of pain in patients with patellofemoral pain (PFP)
Study objectives1. There will be a reduction in pain during squat activities when patellar taping is applied and when placebo taping is applied when compared to baseline
2. MRI will not display any significant differences in patellar positioning following patellar taping and placebo
3. The MRI patellar positioning will correlate with the patellofemoral calliper data
4. The patellofemoral calliper will have good agreement with the MRI equivalent data
5. The patellofemoral caliper will provide good intratester reliability
6. The patellofemoral caliper will not display any significant differences in patellar positioning following taping and placebo
Ethics approval(s)Research Ethics Committee of the College of Health and Life Sciences, 30/01/2015, ref: RE13-14
Health condition(s) or problem(s) studiedPatellofemoral pain
InterventionAll participants will have baseline measures taken at the start of the visit. These include: MRI of the knee in a fixed 30 degrees of flexion position, VAS measured during a squat activity and measurements taken using the patellofemoral calliper for the location of the knee cap. All participants are then assessed again in order to ensure that no changes occur by chance. Participants are then randomly allocated to one of two groups:

Intervention group: Participants will have McConnell taping applied in accordance with the process to alleviate mal-alignment and will have an MRI, a patellofemoral caliper measurement and a squatting movement to assess pain.

Placebo group: Participants will have sham tape applied to the front of the knee without any correction to the position of the knee cap, again participants will have an MRI, a patellofemoral caliper measurement and a squatting movement to assess pain.
Intervention typeProcedure/Surgery
Primary outcome measure1. Bisect offset, patellar overhang, congruence angle, sulcus angle, patellar shift, and equivalent position measurements are measured using MRI extracted data tested before and after each intervention
2. Pain measured using visual analogue scale (VAS) before and after each intervention
3. Relative postions of the patella and femur are measured using patellofemoral caliper measurements tested before and after each intervention
Secondary outcome measures1. Comparisons between the MRI extracted data and the patellofemoral caliper measurements compared after the trials are all completed using MRI data and the mean scores from the caliper
2. Changes in VAS scores measured immediately after interventions correlating to any changes in MRI and caliper measurements
Overall study start date01/01/2016
Completion date06/04/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Aged 18 years or over
2. Symptomatic with anterior knee pain
3. Confirmed as having patellar malalignment by an orthopaedic consultant via X-ray
Key exclusion criteria1. Vulnerable adults or those unable to make decisions for themselves
2. Under 18 years of age
3. Anyone with metal or other implants containing metals such as pacemakers
Date of first enrolment16/10/2017
Date of final enrolment10/02/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

London Sports Orthopaedics
31 Old Broad Street
London
EC2N 1HT
United Kingdom

Sponsor information

Brunel University
University/education

Heinz Wolff Building
Uxbridge
UB8 3PH
England
United Kingdom

Bucks New University
University/education

Queen Alexandra Road
High Wycombe
HP11 2JZ
England
United Kingdom

Brunel University London
Not defined

Funders

Funder type

University/education

Bucks New University
Government organisation / Universities (academic only)
Alternative name(s)
Buckinghamshire New University, School of Science and Art, Wycombe Technical Institute, High Wycombe College of Technology and Art, Buckinghamshire College of Higher Education, Buckinghamshire Chilterns University College, BNU
Location
United Kingdom
Brunel University London
Private sector organisation / Universities (academic only)
Location
United Kingdom

Results and Publications

Intention to publish date01/07/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThis study is intended to be published in peer-reviewed scientific journals. The data will also be shared with the International Patellofemoral Pain research retreat and will be presented at international conferences to the scientific community.

2018 results published in thesis: https://bura.brunel.ac.uk/handle/2438/18284 (added 15/08/2019)
IPD sharing planThe datasets generated during and/or analysed during the current study is not expected to be made available. The data will be stored on a secure server drive at Bucks New University.

Editorial Notes

15/08/2019: Thesis added to publication and dissemination plan, intention to publish date changed from 01/02/2019 to 01/07/2020.
26/03/2018: The overall trial end date was changed from 10/03/2018 to 06/04/2018.
16/10/2017: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/02/2016 to 16/10/2017.
2. The recruitment end date was changed from 16/09/2016 to 10/02/2018.
3. The overall trial end date was changed from 01/10/2016 to 10/03/2018.
4. The intention to publish date was changed from 31/08/2017 to 01/02/2019.
5. IPD sharing statement added.