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Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03145233
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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).

Condition or disease Intervention/treatment Phase
Gluteal Tendinitis Other: Isometric exercise programme Other: Isotonic exercise programme Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome - a Randomised Controlled Trial Comparing Two Rehabilitation Programmes
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : July 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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

Experimental: 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.
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)




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145233


Locations
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United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Study Director: Neal Millar, PhD FRCSEd University of Glasgow
Study Director: Lorna Paul, MPhil PhD Glasgow Caledonian University

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03145233     History of Changes
Other Study ID Numbers: GN17PY175
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Greater Glasgow and Clyde:
physiotherapy
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries