Gluteal TendinopathyNCT04537091
Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for Greater Trochanteric Pain Syndrome
A study testing rESWT and PRP injection in people with Gluteal Tendinopathy and Greater Trochanteric Pain Syndrome, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Greater trochanteric pain syndrome (GTPS), is characterised by pain around the greater trochanter. Failure of first-line management for GTPS is followed by second-line treatments range from extracorporeal shock wave therapy (ESWT), corticosteroid or platelet-rich plasma (PRP) injections, and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gluteal Tendinopathy, Greater Trochanteric Pain Syndrome
- What is being tested?
- rESWT and PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 5 Jan 2021
- 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
- > 18 years old
- Complaining of pain located anterior, lateral or posterior to the great trochanter for more than 3 months
- Pain while lying on the affected side
- Local tenderness on palpation of the area of the great trochanter
- MRI evidence of gluteus minimus or medius tendinopathy
- Refractory to conservative management
Who cannot join
- Presence of signs and symptoms of another cause of regional hip pain.
- Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular structures
- Evidence of concomitant injury to the involved lower extremity, including radiculopathy or radiculitis, ischial tuberosity avulsion
- Severe knee or hip osteoarthritis
- Previous hip surgery or use of ESWT for GTPS.
- Acute low back pain
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- Implanted pacemaker
- Vascular, neurologic, rheumatic diseases.
- Any neoplastic disorders
- Blood coagulation disorders or use of antiplatelet or anticoagulant drugs
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, Bahcelievler, 34180
About this study
Official title: Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for the Treatment of Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
Greater trochanteric pain syndrome (GTPS), is characterised by pain around the greater trochanter. Failure of first-line management for GTPS is followed by second-line treatments range from extracorporeal shock wave therapy (ESWT), corticosteroid or platelet-rich plasma (PRP) injections, and surgery. In a systematic reviews, PRP seems a viable effective and safe alternative option for GTPS after failed physical therapy. Also, positive results from previous systematic reviews involving radial ESWT (rESWT) as a treatment for GTPS.
In the literature review, there is no comparison of the effectiveness of ESWT and PRP injection in patients with GTPS. The aim of this study was to investigate the effects of rESWT and PRP injection on pain, hip disability, and quality of life in patients with GTPS
Read the detailed description
The pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion were evaluted by Harris Hip Score (HHS). The pain severity during rest and activity in the previous week was evaluted by Visual Analog Scale (VAS). The pain and activity limitation was evaluted by The Roles and maudsley (RM). The quality of life was evaluted by The EQ-5D-3L scale.
- Being tested
- rESWT, PRP injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rESWTProcedure or surgery
rESWT was administered once per week for 3 weeks with 4 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses. Radial shock waves were transmitted to the greater trochanteric region with the maximum pain/tenderness that was identified with patients' reaction with small circular movements with an adequate amount of contact gel
PRP injectionProcedure or surgery
PRP injection is performed with a high resolution 7-12-megahertz linear probe ultrasonography device. 15 ml of blood will be drawn from the patients and the blood will be centrifuged for 5 minutes. 4-5 ml PRP will be injected into the affected gluteal tendons accompanied by ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| ESWT group: rESWT | Experimental | rESWT treatment was applied to patients Receives: Procedure: rESWT |
| PRP group: PRP injection | Experimental | PRP treatment was applied to patients Receives: Procedure: PRP injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
The index consists of questions about pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion. Score ranges from 100 (no disability) to 0 (maximum disability).
Measured: Changes from baseline in Harris Hip Score to 1 month and 6 months.
Secondary outcomes (3)
Visual Analog Scale (VAS)
The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale, where 0 in the left corner of the scale represented 'no pain' and 10 in the right corner represented 'the worst pain that could be imagined'
Measured: Changes from baseline in Visual Analog Scale score to 1 month and 6 months.
The Roles and maudsley (RM)
RM score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, 2 points = good, 3 points = fair, and 4 points = poor.
Measured: Changes from baseline in Roles and maudsley score to 1 month and 6 months.
EuroQol five-dimensional questionnaire (EQ-5D-3L)
The EQ-5D-3L scale, which scores five health conditions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) through evaluation at 3 levels (no problems, some problems, or extreme problems), was used to evaluate the quality of life.
Measured: Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gluteal TendinopathyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Corum, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Mustafa Corum, MD, Study chair, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537091
- Sponsor's protocol ID
- 2020-309
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for the Treatment of Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04537091
- Acronym / sponsor ID
- 2020-309
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 3 Sep 2020 (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.
Greater trochanteric pain syndrome (GTPS), is characterised by pain around the greater trochanter. Failure of first-line management for GTPS is followed by second-line treatments range from extracorporeal shock wave therapy (ESWT), corticosteroid or platelet-rich plasma (PRP) injections, and surgery. In a systematic reviews, PRP seems a viable effective and safe alternative option for GTPS after failed physical therapy. Also, positive results from previous systematic reviews involving radial ESWT (rESWT) as a treatment for GTPS.
In the literature review, there is no comparison of the effectiveness of ESWT and PRP injection in patients with GTPS. The aim of this study was to investigate the effects of rESWT and PRP injection on pain, hip disability, and quality of life in patients with GTPS
Detailed description
The pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion were evaluted by Harris Hip Score (HHS). The pain severity during rest and activity in the previous week was evaluted by Visual Analog Scale (VAS). The pain and activity limitation was evaluted by The Roles and maudsley (RM). The quality of life was evaluted by The EQ-5D-3L scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT group: rESWT | Experimental | Procedure: rESWTrESWT treatment was applied to patients |
| PRP group: PRP injection | Experimental | Procedure: PRP injectionPRP treatment was applied to patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 18 years old
- Complaining of pain located anterior, lateral or posterior to the great trochanter for more than 3 months
- Pain while lying on the affected side
- Local tenderness on palpation of the area of the great trochanter
- MRI evidence of gluteus minimus or medius tendinopathy
Key exclusion criteria (11 listed)
- Presence of signs and symptoms of another cause of regional hip pain.
- Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular structures
- Evidence of concomitant injury to the involved lower extremity, including radiculopathy or radiculitis, ischial tuberosity avulsion
- Severe knee or hip osteoarthritis
- Previous hip surgery or use of ESWT for GTPS.
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 |
|---|---|---|
| rESWTrESWT was administered once per week for 3 weeks with 4 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses. Radial shock waves were transmitted to the greater trochanteric region with the maximum pain/tenderness that was identified with patients' reaction with small circular movements with an adequate amount of contact gel | Procedure or surgery | ESWT group: rESWT |
| PRP injectionPRP injection is performed with a high resolution 7-12-megahertz linear probe ultrasonography device. 15 ml of blood will be drawn from the patients and the blood will be centrifuged for 5 minutes. 4-5 ml PRP will be injected into the affected gluteal tendons accompanied by ultrasonography. | Procedure or surgery | PRP group: PRP injection |
Primary outcome
Harris Hip Score (HHS)
Time frame: Changes from baseline in Harris Hip Score to 1 month and 6 months.
The index consists of questions about pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion. Score ranges from 100 (no disability) to 0 (maximum disability).
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Changes from baseline in Visual Analog Scale score to 1 month and 6 months.
The Roles and maudsley (RM)
Time frame: Changes from baseline in Roles and maudsley score to 1 month and 6 months.
EuroQol five-dimensional questionnaire (EQ-5D-3L)
Time frame: Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.
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 10 Feb 2021.
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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.
Mustafa Corum, MD study chair
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rESWT and PRP injection in people with Gluteal Tendinopathy and Greater Trochanteric Pain Syndrome, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 11 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 10 Feb 2021. 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 Turkey (Türkiye). 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?
Harris Hip Score (HHS) (time frame: Changes from baseline in Harris Hip Score to 1 month and 6 months.). 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 10 Feb 2021.