Condition category
Musculoskeletal Diseases
Date applied
28/07/2015
Date assigned
23/08/2015
Last edited
12/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patellofemoral pain syndrome (knee pain in young adults) happens when the kneecap (patella) is affected by imbalances in the muscles surrounding the knee joint. One of the causes is excessive tightness of the calf muscles. This study investigates if a massage technique (called transverse friction massage) combined with a home stretching exercise programme works better in treating the condition than the stretching exercises alone.

Who can participate?
Patients aged 16 or over with patellofemoral pain syndrome.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group A receive a self-stretching programme to do at home. Those in group B hare given the same stretching programme and also the
transverse friction massage to the gastrocnemius (calf muscle). All participants attend the trial participating centre 3 times over the study period. This involves an initial assessment at the start of the study, a follow-up visit 2 weeks into the study and a final one 4 weeks into the study. A review of the participants progress is made at the two follow up visits and those in group B receive their massage treatment during this time.

What are the possible benefits and risks of participating?
The use of stretches and transverse friction massage to the calf muscles are treatment techniques that are commonly used by physiotherapists for this and other conditions. The risk to the patient is minimal. On rare occasions there may be some mild soreness to the calf muscle however this usually settles within a 24 hour period.

Where is the study run from?
Northern Devon District Hospital and Precision Physiotherapy, Bideford (UK)

When is the study starting and how long is it expected to run for?
October 2014 to September 2015

Who is funding the study?
Middlesex University (UK)

Who is the main contact?
Mr Stuart Hall

Trial website

Contact information

Type

Public

Primary contact

Mr Stuart Hall

ORCID ID

Contact details

Precision Physiotherapy
52 Bay View Road
Northam
Bideford
EX39 1BH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of stretches and transverse friction massage to the gastrocnemius in patients with patellofemoral pain syndrome (PFPS) – a pilot interventional study

Acronym

Study hypothesis

1. Hypothesis 1
There is a reduction in pain with patients with PFPS who receive transverse friction massage and stretches compared to patients who receive a stretching regimen alone
2. Hypothesis 2
There is an improvement in function with patients with PFPS who receive transverse friction massage compared to patients who receive a stretching regimen alone
3. Null hypothesis 1
There is no difference in pain with patients with PFPS who receive transverse friction massage and stretches compared to patients who receive a stretching regime alone
4. Null hypothesis 2
There is no difference in function with patients with PFPS who receive transverse friction massage and stretches compared to patients who receive a stretching regime alone

Ethics approval

1. London Sport Institute Ethics Sub-Committee, 21/04/2015, ref: 351
2. West of Scotland Research Ethics Service, 10/09/2015, ref: 15/WS/0172

Study design

Pilot interventional study

Primary study design

Interventional

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Patellofemoral pain syndrome

Intervention

There will be two treatment arms for the study which will be called groups A and B.
Group A will be taught home stretches for their gastrocnemius.
Group B will be taught the same stretching programme however will also recieve 3 sessions of transverse friction massage which will be applied to the lateral head of gastrocnemius for 10 minutes.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Reduction in pain measured on VAS and Eccentric step down test.

Assessed at baseline, and at 2 weeks and 4 weeks follow-up

Secondary outcome measures

Improvement in function which will be measured by Modified Functional Index Questionnaire and Eccentric step down test.

Assessed at baseline, and at 2 weeks and 4 weeks follow-up

Overall trial start date

10/10/2014

Overall trial end date

28/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Participants may be aged from 16 and above, with no upper age limitation. History of characteristic history and symptoms of patellofemoral joint pain for more than 6 weeks, defined as retropatellar pain during physical activities such as jumping, running, squatting and going up and down stairs.
Exhibit at least two of the following physical criteria:
1. Pain on direct compression of the patella against the femoral condyles with the knee in full extension
2. Tenderness of the posterior surface of the patella on palpation
3. Pain on resisted knee extension in 15º of flexion
4. Negative findings in the examination of the other knee structures, i.e. ligaments, menisci, bursae, synovial plicae, Hoffa’s fat pad, Iliotibial band, and the hamstrings, quadriceps, patellar tendons and their insertions.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Referred pain to the lower limb from any spinal, pelvic or hip joints
2. Pregnancy
3. Joint replacement, ligamentous or meniscal surgery
4. Intra-articular loose bodies
5. Increased temperature of the knee joint
6. Abnormal illness behaviour
7. Rheumatoid arthritis
8. Heart conditions
9. Peripheral vascular disease

Recruitment start date

01/06/2015

Recruitment end date

28/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Devon District Hospital
Raleigh Park
Barnstaple
EX31 4JB
United Kingdom

Trial participating centre

Precision Physiotherapy
52 Bay View Road Northam
Bideford
EX39 1BH
United Kingdom

Sponsor information

Organisation

Middlesex University

Sponsor details

c/o Dr Elaine Atkins
Programme Leader MSc Orthopaedic Medicine
The Archway Campus
Highgate Hill
London
N19 5LW
United Kingdom

Sponsor type

University/education

Website

http://www.mdx.ac.uk/

Funders

Funder type

University/education

Funder name

Middlesex University (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/05/2016: Ethics approval information added.