Condition category
Musculoskeletal Diseases
Date applied
18/06/2018
Date assigned
25/07/2018
Last edited
05/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Background and study aims
Greater Trochanter Pain Syndrome (GTPS) is a painful condition affecting the tendons on the outer side of the hip.The most common symptom is pain over the outer thigh, particularly felt when the muscles contract during walking or climbing steps and slopes, but also when lying on the affected side at night. The pain can affect normal daily activities such as walking and sleeping.
Treatment is usually a corticosteroid injection or physiotherapy but we do not know which treatment works best long term. Research into other tendon problems has shown that some types of exercise can ease pain and improve daily activity. This study is to see whether exercise can help patients with GTPS. It is a pilot study that will help us to plan a larger research trial.

Who can participate?
Men or women between the ages of 35 and 70 can take part if they have been referred to physiotherapy for GTPS by their General Practitioner (GP).

What does the study involve?
All participants will have a corticosteroid injection and advice. Half the participants will be randomly selected to do exercises at home and attend five group classes held in a physiotherapy department.
All participants will fill in questionnaires about their activity level and pain at the beginning of the study, after 3 months and 1 year. We will compare the pain and activity of participants having injection and advice with participants who also did exercise.

What are the possible benefits and risks of participating?
There is no extra benefit from taking part. Research like this helps to improve the treatment and care provided to patients with GTPS now and in the future.
The normal risks of treatment apply. Exercise can cause soreness for up to 48 hours but the exercises in the study are designed to reduce the risk of this.
Possible side-effects of corticosteroid injection are a temporary increase in pain, a change in skin colour or a dimple where the injection has been given. These side effects happen occasionally. Less common but more serious side effects include infection, muscle damage or unwanted reaction to local anaesthetic or steroid.

Where is the study run from?
The study is run by the Royal Devon & Exeter Hospital, Devon, UK. Three physiotherapy departments will provide the exercise groups and advice sessions.

When is the study starting and how long is it expected to run for?
The study is expected to start in October 2018 and run for 2 years

Who is funding the study?
The study has been funded by a Physiotherapy Research Foundation project grant. This is part of the Chartered Society of Physiotherapy Charitable Trust.

Who is the main contact?
Alison Smeatham
Alisonsmeatham@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Ms Alison Smeatham

ORCID ID

Contact details

Hip Research Unit. Royal Devon & Exeter NHS Foundation Trust. Barrack Road.
Exeter
EX2 5DW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1810689

Study information

Scientific title

Does the addition of an exercise programme improve outcomes in Greater Trochanter Pain Syndrome compared to corticosteroid injection and advice? A pilot study

Acronym

Study hypothesis

To inform the design and methodology of a future randomised controlled trial (RCT) comparing an exercise programme with routine care on the symptoms of greater trochanter pain syndrome (GTPS).

Ethics approval

To be submitted July 2018 to South West UK Research Ethics Committee

Study design

Pilot single-centre single-blind interventional randomised controlled trial

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 below to request a patient information sheet.

Condition

Greater trochanter pain syndrome

Intervention

Intervention group: Corticosteroid injection and 5 sessions of group exercise and advice supervised by a physiotherapist plus a home exercise programme
Routine care group: Corticosteroid injection and a single physiotherapy session providing advice on self-management of the condition.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Change in GTPS-related disability assessed using VISA-G questionnaire score at 3 and 12 months

Secondary outcome measures

1. Change in quality of life assessed using EQ-5D questionnaire at 3 and 12 months
2. Change in musculoskeletal symptoms and quality of life assessed using MSK-HQ questionnaire at 3 and 12 months
3. Self-reported assessment of activity level assessed using UCLA questionnaire (Zahiri et al., 1998) scores at 3 and 12 months

Overall trial start date

01/01/2018

Overall trial end date

01/05/2021

Reason abandoned (if study stopped)

Ethics approval not received.

Eligibility

Participant inclusion criteria

1. Aged 35-70 years
2. Unilateral or bilateral trochanteric pain for greater than 3 months
3. Pain on walking and climbing slopes or stairs and/or lying on the affected side
4. Absence of groin pain
5. Tenderness on palpation of the greater trochanter
6. At least one of the following tests provocative of lateral hip pain: Combined hip flexion, abduction and external rotation (FABER); Active derotation test; Combined hip flexion, adduction and external rotation; Modified Ober test; 30 second single leg stance; Active hip abduction at end range adduction in side lying
7. Hip osteoarthritis excluded radiologically

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Evidence of osteoarthritis on X-ray (over grade 1)
2. Previous lower limb surgery affecting gait
3. Arthroplasty of the affected hip
4. Other neuromuscular or musculoskeletal conditions affecting gait or ability to exercise
5. Corticosteroid injections/physiotherapy/extracorporeal shock wave therapy (ECSWT) for GTPS in the last 3 months
6. Range of hip flexion <90 degrees
7. Significant lumbar pathology/pain
8. Previous lumbar nerve root entrapment or spinal surgery
9. Unable or unwilling to comply with study protocol
10. Unable or unwilling to offer written consent to the study
11. Unable to understand written or spoken English
12. Adverse reaction to steroid

Recruitment start date

01/10/2018

Recruitment end date

01/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Royal Devon & Exeter NHS Foundation Trust

Sponsor details

Research and Development Unit. Noy Scott House. Royal Devon & Exeter NHS Foundation Trust. Barrack Road.
Exeter
EX2 5DW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Chartered Society of Physiotherapy Charitable Trust

Alternative name(s)

CSP Charitable Trust, The Chartered Society of Physiotherapy Charitable Trust, The CSP Charitable Trust, CSPCT

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication and dissemination of the results is planned for May 2021. This will include publication of an open access paper in a peer-reviewed journal and presentation at the Physiotherapy UK conference.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/11/2019: The trial's status has been changed to 'stopped'.