Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome

NCT ID: NCT03145233

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-07-06

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.

Conditions

Gluteal Tendinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Isometric exercise

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.

Group Type: EXPERIMENTAL

Isometric exercise programme

Intervention Type: OTHER

Exercise programme where the muscle length and joint angle do not change due to the limb being held in a static position

Isotonic exercise

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.

Group Type: EXPERIMENTAL

Isotonic exercise programme

Intervention Type: OTHER

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)

Interventions

Isometric exercise programme

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

Isotonic exercise programme

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)

Intervention Type: OTHER

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neal Millar, PhD FRCSEd

Role: STUDY_DIRECTOR

University of Glasgow

Lorna Paul, MPhil PhD

Role: STUDY_DIRECTOR

Glasgow Caledonian University

Locations

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

GN17PY175

Identifier Type: -

Identifier Source: org_study_id