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Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome

Primary Purpose

Gluteal Tendinitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Isometric exercise programme
Isotonic exercise programme
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gluteal Tendinitis focused on measuring physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to give written informed consent
  • Lateral hip pain for greater than 3 months
  • Pain on direct palpation of the gluteal tendon insertion on the greater trochanter and additionally at least one of the following pain provocation tests must also be positive:

    1. FABER (Flexion, Abduction, External Rotation of the hip)
    2. FADER (Flexion, Adduction, External Rotation of the hip)
    3. FADER and resisted Internal Rotation (IR) (FADER position plus resisted IR of the hip)
    4. Single leg stand for 30 seconds
    5. Resisted hip abduction at end-range adduction

Exclusion Criteria:

  • Physiotherapy for lateral hip pain in the past 6 months
  • Corticosteroid injection for lateral hip pain in past 3 months
  • Inability to actively abduct hip in side-lying
  • Pain reproduced with FADIR (Flexion, Adduction, Internal Rotation of hip) with concurrent hip osteoarthritis on anteroposterior (AP) pelvis x-ray defined as Kellgren-Lawrence > Grade 2 (mild)
  • Previous hip or lumbar spine surgery in past 12 months
  • Inflammatory joint disease
  • Unstable diabetes or cardiovascular disease
  • Known neurological disorders
  • Widespread chronic pain or fibromyalgia
  • Avascular necrosis
  • Pregnancy
  • Participants unable or unwilling to give informed consent
  • Participants who are unable to write, read or comprehend English

Sites / Locations

  • NHS Greater Glasgow and Clyde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Isometric exercise

Isotonic exercise

Arm Description

12 week Isometric exercise programme - two exercises (one side-lying and the other standing); six repetitions of each with muscle contraction sustained for 30 seconds. Exercises performed once daily with each session lasting no longer than 10 minutes.

12 week Isotonic exercise programme - two exercises (one side-lying and the other standing); each exercise - 3 sets of 10 repetitions, each repetition 6 seconds duration. Exercises performed once daily with each session lasting no longer than 10 minutes.

Outcomes

Primary Outcome Measures

Measure of disability
Change in score on Victorian Institute of Sport Assessment-Gluteal (VISA-G) questionnaire

Secondary Outcome Measures

Quality of Life
Change in score on European Quality of Life (EQ-5D-5L) questionnaire
Perceived change in hip pain
Change in score on Global Rating of Change (GROC) Scale
Pain intensity
Change in score on Numeric Pain Rating Scale (NPRS)
Pain catastrophisation
Change in score on Pain Catastrophising Scale
Hip disability
Change in score on Hip Disability and Osteoarthritis Outcome Score (HOOS)
Physical activity
Change in score on International Physical Activity Questionnaire Short Form (IPAQ-SF)

Full Information

First Posted
April 25, 2017
Last Updated
July 18, 2018
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT03145233
Brief Title
Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome
Official Title
Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome - a Randomised Controlled Trial Comparing Two Rehabilitation Programmes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot randomised controlled trial will directly compare the effect of isometric exercise to isotonic exercise over a period of 12 weeks for participants with a clinical diagnosis of Greater Trochanteric Pain Syndrome (GTPS).
Detailed Description
Pain at the side of the hip over or around the greater trochanter of the femur has previously been termed as Greater Trochanteric Pain Syndrome (GTPS). Recent research has found that it is normally due to the gluteal tendons being torn or injured and is often termed as 'gluteal tendinopathy'. GTPS predominantly affects adults aged 40-60 years and is the second most common condition affecting the hip region after osteoarthritis. Quality of life scores are similar to those with advanced hip osteoarthritis but despite its prevalence and disease burden the most effective treatment for this problem is currently unknown. Numerous studies have shown that exercise programmes are the most effective treatment for other lower limb tendon problems, particularly the Achilles and patella. These programmes typically last a minimum of 12 weeks and are often prescribed by physiotherapists as first-line treatment. However, there is currently limited evidence to support exercise for gluteal tendinopathy. The study plans to directly compare two different types of exercise programmes for those with GTPS for a period of 12 weeks. One group will receive an isometric exercise programme (where the muscle length does not change) and a second group an isotonic exercise programme (where the muscle length does change). The primary outcome measure which will be used has recently been validated for patients with gluteal tendinopathy and measures function and disability. Additional secondary outcome measures will evaluate aspects relating to quality of life, physical activity and pain. Both groups will be compared at the start of the study and at different times up to a maximum of 12 weeks to help determine if one exercise programme is better than the other. The results of this pilot study will also help to identify whether a larger trial would be possible in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gluteal Tendinitis
Keywords
physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isometric exercise
Arm Type
Experimental
Arm Description
12 week Isometric exercise programme - two exercises (one side-lying and the other standing); six repetitions of each with muscle contraction sustained for 30 seconds. Exercises performed once daily with each session lasting no longer than 10 minutes.
Arm Title
Isotonic exercise
Arm Type
Experimental
Arm Description
12 week Isotonic exercise programme - two exercises (one side-lying and the other standing); each exercise - 3 sets of 10 repetitions, each repetition 6 seconds duration. Exercises performed once daily with each session lasting no longer than 10 minutes.
Intervention Type
Other
Intervention Name(s)
Isometric exercise programme
Intervention Description
Exercise programme where the muscle length and joint angle do not change due to the limb being held in a static position
Intervention Type
Other
Intervention Name(s)
Isotonic exercise programme
Intervention Description
Exercise programme where both the muscle length and joint angle do change, consisting of concentric muscle actions (where the muscle shortens) and eccentric muscle actions (where the muscle lengthens)
Primary Outcome Measure Information:
Title
Measure of disability
Description
Change in score on Victorian Institute of Sport Assessment-Gluteal (VISA-G) questionnaire
Time Frame
Baseline, 4 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Change in score on European Quality of Life (EQ-5D-5L) questionnaire
Time Frame
Baseline, 4 weeks and 12 weeks
Title
Perceived change in hip pain
Description
Change in score on Global Rating of Change (GROC) Scale
Time Frame
Baseline, 4 weeks and 12 weeks
Title
Pain intensity
Description
Change in score on Numeric Pain Rating Scale (NPRS)
Time Frame
Baseline, 4 weeks and 12 weeks
Title
Pain catastrophisation
Description
Change in score on Pain Catastrophising Scale
Time Frame
Baseline, 4 weeks and 12 weeks
Title
Hip disability
Description
Change in score on Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time Frame
Baseline, 4 weeks and 12 weeks
Title
Physical activity
Description
Change in score on International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame
Baseline, 4 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to give written informed consent Lateral hip pain for greater than 3 months Pain on direct palpation of the gluteal tendon insertion on the greater trochanter and additionally at least one of the following pain provocation tests must also be positive: FABER (Flexion, Abduction, External Rotation of the hip) FADER (Flexion, Adduction, External Rotation of the hip) FADER and resisted Internal Rotation (IR) (FADER position plus resisted IR of the hip) Single leg stand for 30 seconds Resisted hip abduction at end-range adduction Exclusion Criteria: Physiotherapy for lateral hip pain in the past 6 months Corticosteroid injection for lateral hip pain in past 3 months Inability to actively abduct hip in side-lying Pain reproduced with FADIR (Flexion, Adduction, Internal Rotation of hip) with concurrent hip osteoarthritis on anteroposterior (AP) pelvis x-ray defined as Kellgren-Lawrence > Grade 2 (mild) Previous hip or lumbar spine surgery in past 12 months Inflammatory joint disease Unstable diabetes or cardiovascular disease Known neurological disorders Widespread chronic pain or fibromyalgia Avascular necrosis Pregnancy Participants unable or unwilling to give informed consent Participants who are unable to write, read or comprehend English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Millar, PhD FRCSEd
Organizational Affiliation
University of Glasgow
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lorna Paul, MPhil PhD
Organizational Affiliation
Glasgow Caledonian University
Official's Role
Study Director
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome

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