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Completed

NCT Number: NCT03145233

Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isometric exercise programme

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 programme

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)

Primary outcomes

  1. Measure of disability

    Time frame: Baseline, 4 weeks and 12 weeks

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

Secondary outcomes

  1. Quality of Life

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in score on European Quality of Life (EQ-5D-5L) questionnaire

  2. Perceived change in hip pain

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in score on Global Rating of Change (GROC) Scale

  3. Pain intensity

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in score on Numeric Pain Rating Scale (NPRS)

  4. Pain catastrophisation

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in score on Pain Catastrophising Scale

  5. Hip disability

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in score on Hip Disability and Osteoarthritis Outcome Score (HOOS)

  6. Physical activity

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in score on International Physical Activity Questionnaire Short Form (IPAQ-SF)

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome - a Randomised Controlled Trial Comparing Two Rehabilitation Programmes

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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