Gluteal TendinitisNCT03145233
Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome
A study testing Isometric exercise programme and Isotonic exercise programme in people with Gluteal Tendinitis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gluteal Tendinitis
- What is being tested?
- Isometric exercise programme and Isotonic exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2017to 6 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome - a Randomised Controlled Trial Comparing Two Rehabilitation Programmes
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).
Read the 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
- Being tested
- Isometric exercise programme, Isotonic exercise programme
- Keywords
- physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exercise programmeOther
Exercise programme where the muscle length and joint angle do not change due to the limb being held in a static position
Isotonic exercise programmeOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise | Experimental | 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. Receives: Other: Isometric exercise programme |
| Isotonic exercise | Experimental | 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. Receives: Other: Isotonic exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of disability
Change in score on Victorian Institute of Sport Assessment-Gluteal (VISA-G) questionnaire
Measured: Baseline, 4 weeks and 12 weeks
Secondary outcomes (6)
Quality of Life
Change in score on European Quality of Life (EQ-5D-5L) questionnaire
Measured: Baseline, 4 weeks and 12 weeks
Perceived change in hip pain
Change in score on Global Rating of Change (GROC) Scale
Measured: Baseline, 4 weeks and 12 weeks
Pain intensity
Change in score on Numeric Pain Rating Scale (NPRS)
Measured: Baseline, 4 weeks and 12 weeks
Pain catastrophisation
Change in score on Pain Catastrophising Scale
Measured: Baseline, 4 weeks and 12 weeks
Hip disability
Change in score on Hip Disability and Osteoarthritis Outcome Score (HOOS)
Measured: Baseline, 4 weeks and 12 weeks
Physical activity
Change in score on International Physical Activity Questionnaire Short Form (IPAQ-SF)
Measured: Baseline, 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Aug 2017
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gluteal TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Neal Millar, PhD FRCSEd, Study director, University of GlasgowLorna Paul, MPhil PhD, Study director, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145233
- Sponsor's protocol ID
- GN17PY175
- Status last verified
- Jul 2018
- First submitted
- 25 Apr 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isometric Versus Isotonic Exercise for Greater Trochanteric Pain Syndrome - a Randomised Controlled Trial Comparing Two Rehabilitation Programmes
- ClinicalTrials.gov ID
- NCT03145233
- Acronym / sponsor ID
- GN17PY175
- Conditions
- Gluteal Tendinitis
- Keywords
- physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise | Experimental | Other: Isometric exercise programme12 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. |
| Isotonic exercise | Experimental | Other: Isotonic exercise programme12 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric exercise programmeExercise programme where the muscle length and joint angle do not change due to the limb being held in a static position | Other | Isometric exercise |
| Isotonic exercise programmeExercise 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) | Other | Isotonic exercise |
Primary outcome
Measure of disability
Time frame: Baseline, 4 weeks and 12 weeks
Change in score on Victorian Institute of Sport Assessment-Gluteal (VISA-G) questionnaire
6 secondary outcomes
Quality of Life
Time frame: Baseline, 4 weeks and 12 weeks
Perceived change in hip pain
Time frame: Baseline, 4 weeks and 12 weeks
Pain intensity
Time frame: Baseline, 4 weeks and 12 weeks
Pain catastrophisation
Time frame: Baseline, 4 weeks and 12 weeks
Hip disability
Time frame: Baseline, 4 weeks and 12 weeks
Physical activity
Time frame: Baseline, 4 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Gluteal Tendinitis
Not yet recruiting
Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis
Tendinopathy, Tendinosis
Recruiting
Exercise and Patient Education for Patients With Lateral Hip Pain
Gluteal Tendinitis, Greater Trochanteric Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Millar, PhD FRCSEd study director
University of Glasgow
Lorna Paul, MPhil PhD study director
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise programme and Isotonic exercise programme in people with Gluteal Tendinitis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of disability (time frame: Baseline, 4 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.