Clinical trial NCT03145233: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gluteal Tendinitis
Keywords: physiotherapy
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2017-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measure of disability
timeFrame: Baseline, 4 weeks and 12 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Perceived change in hip pain
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Pain intensity
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Pain catastrophisation
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Hip disability
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Physical activity
timeFrame: Baseline, 4 weeks and 12 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
affiliation: University of Glasgow
name: Neal Millar, PhD FRCSEd
role: STUDY_DIRECTOR
affiliation: Glasgow Caledonian University
name: Lorna Paul, MPhil PhD
role: STUDY_DIRECTOR
References: