Condition category
Musculoskeletal Diseases
Date applied
19/12/2016
Date assigned
19/12/2016
Last edited
24/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Knee pain is a common complaint, with 1 in 6 young adults suffering from pain around the kneecap at any one time. The routine treatment is physiotherapy and painkillers, but current long-term outcomes are poor with 91% of patients reporting pain 4 years after starting treatment. This means that many patients are exposed to potential long-term disability and pain. Patients with this complaint will typically receive a course of physiotherapy which can include a variety of treatments. These may include strengthening exercises, taping, stretches and foot orthoses. The use of strengthening exercises has been shown to be most promising, but the best ‘dose’ remains unclear. Strengthening exercises which are self-managed and include movements that reproduce the patient’s symptoms have been shown to be beneficial for the back and shoulders, but further investigation is needed to evaluate these exercises for the knee and particularly in relation to home based exercise versus usual physiotherapy. The purpose of this study is to evaluate the feasibility of running a large scale study into whether a self-managed weight bearing exercise programme is more effective than usual physiotherapy in reducing pain and improving function in people with pain around the kneecap. As part of this study some people will also be invited to discuss their experience of physiotherapy.

Who can participate?
Adults with knee pain in one or both knees.

What does the study involve?
In the first part of the study, 8-10 people are interviewed in order to find out about the impact that knee pain has on their lives. In the second part of the study, a group of participants are randomly allocated to one of two groups. Those in the first group take part in a loaded self-managed exercise programme for the knee, aimed at addressing lower limb knee and hip weakness. This involves completing exercises prescribed by a physiotherapist designed to strengthen the knee. Participants are advised to push themselves to the point of tiring, maintaining a manageable pain level. Those in the second group receive usual physiotherapy. The length of treatment in both groups is left to their discretion of the treating physician. In both groups, participants have their pain levels and knee function assessed at the start of the study and then again after three and six months. In the third part of the study, a small group of patients from part two are interviewed in order to find out how acceptable the study procedures have been for them.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There are no disadvantages or risks to taking part in this research. Essentially participants will be receiving a course of physiotherapy as they would expect following a referral to a physiotherapy department. The physiotherapy exercises will likely cause some short term temporary pain and discomfort.

Where is the study run from?
London Road Community Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2016 to March 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Benjamin Smith
benjamin.smith@nottingham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Benjamin Smith

ORCID ID

http://orcid.org/0000-0002-4723-0028

Contact details

Physiotherapy Outpatients
London Road Community Hospital
Derby Teaching Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
+44 (0)1332 254631
benjamin.smith@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32042

Study information

Scientific title

A loaded self-managed exercise programme for patellofemoral pain: a mixed methods feasibility study

Acronym

Study hypothesis

The aim of this study is to establish the feasibility and acceptability of conducting a definitive randomised controlled trial which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with patellofemoral pain.

Ethics approval

West Midlands - Black Country Research Ethics Committee, 07/11/2016, ref: 16/WM/0414

Study design

Randomised; Both; Design type: Treatment, Education or Self-Management, Complex Intervention, Physical, Rehabilitation, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Musculoskeletal disorders, Primary sub-specialty: Musculoskeletal Pain Disorders; UKCRC code/ Disease: Musculoskeletal/ Other joint disorders

Intervention

Phase 1:
8 to 10 participants will be recruited and undergo individual interviews in order to understand the impact of PFP with their lives. Their physiotherapy will continue as normal.

Phase 2:
Participants are randomised to one of two groups using a web-based randomisation service with secure password protected login using random variable block-size.

Intervention group: Participants participate in the loaded self-managed exercise programme for the knee, aimed at addressing lower limb knee and hip weakness. It is set within a framework of reducing fear/avoidance and with an emphasis on self-management and reducing the need for direct physiotherapy intervention. The exercise will be prescribed by the physiotherapist and will typically involve body weight resistance in the form of a single leg squatting exercise sideways on a step. The patient is advised to exercise to the point of fatigue, through some pain and discomfort, ensuring the pain is manageable. Exercise progression and regression is guided by symptomatic response, such that the patient is advised that on cessation of the exercise the pain should remain no worse than pre-exercise. Patients will be advised to exercise at a level they find acceptable and tolerable. Patients are able to start exercising, if they wish, at a very low level, with little or no short term pain increase, and progress when they feel comfortable and confident.

Control group: Participants receive usual physiotherapy.

Keeping the treatment pragmatic, duration of treatment and frequency of sessions in both treatment arms will be at the discretion of the treating physiotherapist. Participants in both groups are then followed up after 3 and 6 months.

Phase 3:
A sub group of participants (8 to 10) from phase 2, along with a sub-group of the physiotherapists involved in phase 2 (8 –10), will be asked to take part in individual interviews that will explore the acceptability and feasibility of study design parameters and the intervention from phase 2.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Global rating of change (the proportion of participants who have recovered) is assessed using a 7 point Likert scale ranging from “completely recovered” to “worse than ever” at 3 and 6 months.

Secondary outcome measures

1. Average pain is measured using the visual analogue scale (VAS; 0 to 10 cm) at baseline, 3 and 6 months
2. Kinesiophobia is measured using the Tampa Scale for Kinesiophobia (TSK) at baseline, 3 and 6 months
3. Catastrophizing is measured using the ‘Pain Catastrophizing Scale’ (PCS) at baseline, 3 and 6 months
4. Self-efficacy measured using the General Self Efficacy Scale (GSES) at baseline, 3 and 6 months
5. Leisure time sport or exercises within a week is measured with a questionnaire at baseline, 3 and 6 months
6. Health score ismeasured using the generic Euro-QOL (EQ-5D-5L) at baseline, 3 and 6 months

Overall trial start date

01/04/2016

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 40
2. Able to give written informed consent
3. Clinical diagnosis of unilateral or bilateral PFP of greater than 3 months duration
4. Anterior or retropatellar pain reported on at least two of the following activities:
4.1. Prolonged sitting
4.2 Ascending or descending stairs
4.3. Squatting
4.4. Jumping
4.5. Running

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 70; UK Sample Size: 70

Participant exclusion criteria

1. Previous knee surgery, or awaiting lower limb surgery
2. Knee ligamentous instability
3. History of patella dislocations
4. True knee locking or giving way
5. Reasons to suspect systemic pathology, or acute illness
6. Pregnancy or breast feeding
7. Patella or iliotibial tract tendinopathy

Recruitment start date

03/10/2016

Recruitment end date

01/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London Road Community Hospital
Derby Teaching Hospitals NHS Foundation Trust London Road
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Derby Teaching Hospitals NHS Foundation Trust

Sponsor details

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal 31/03/2020. Also the study will form part of a PhD thesis.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Benjamin Smith (Benjamin.smith3@nhs.net).

Intention to publish date

31/03/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 protocol in: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-017-0167-2

Publication citations

Additional files

Editorial Notes

24/07/2017: Publication reference added. 10/07/2017: Target number of participants has been updated from 90 to 70.