- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01642043
Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome
Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome (GTPS)
Greater trochanteric pain syndrome (GTPS) is a common cause of musculoskeletal pain.
The primary aim of this study is to describe the soft tissue and bony structural ultrasound (US) findings identified in the lateral hip and iliotibial band (ITB) in patients presenting with greater trochanteric pain syndrome (GTPS) in an outpatient rheumatology clinic.
Study Overview
Status
Conditions
Detailed Description
GTPS, widely known as trochanteric bursitis, encompasses a spectrum of disorders (gluteal tendinopathy, tears, bursitis, and ITB syndrome) that are difficult to distinguish by clinical exam alone. Better understanding of US imaging characteristics in relation to clinical symptoms may be helpful in identifying those patients who would most benefit from corticosteroid injections and other non-operative treatment options.
Point-of-care musculoskeletal US use has been shown to reduce repeated hospital appointments, improve accuracy of diagnosis, and provide expedited treatment, thus improving quality of care in an outpatient musculoskeletal clinic. US assessment is not routinely included in the management of GTPS patients and ideal imaging modalities are not established.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Lateral hip pain thought to be due to GTPS as evidenced by tenderness to palpation of the lateral hip over the greater trochanter
- Have a pain score of at least 2 out of 10 on an 11-point numeric rating scale
- Lateral hip pain for at least 1 week
- For participants with bilateral GTPS, the most symptomatic hip will be considered the study hip
- Have a telephone
Exclusion Criteria:
- Inability to give informed consent
- BMI > 40
- Evidence of severe OA of the study hip by X-ray
- Avascular necrosis of the study hip
- Groin pain at rest or with log-rolling
- Hip internal rotation range of motion < 15 degrees
- Prior fracture involving the study hip or femur
- Prior hip surgery or prosthesis in the painful hip
- Paralysis or paresis of the lower extremity
- Wheelchair bound
- Open wound or skin lesions in the lateral hip
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive diagnostic ultrasound findings of the bony and soft tissue structures of the lateral hip and iliotibial band
Time Frame: Baseline
|
Presence of tendinopathy, tendon tears, bursitis, enthesophytes, calcifications
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain with rest measured by a numeric rating scale
Time Frame: Baseline and 2 weeks
|
Baseline and 2 weeks
|
|
Pain with activity as measured by a numeric rating scale
Time Frame: Baseline and 2 weeks
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Baseline and 2 weeks
|
|
Demographics- composite
Time Frame: Baseline
|
age, gender, race/ethnicity, education, occupation, comorbidities, overall health status.
|
Baseline
|
Pressure point threshold as measured by an algometer
Time Frame: Baseline
|
Baseline
|
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Clinical data: Predictors of treatment response- composite
Time Frame: Baseline
|
|
Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Minna J. Kohler, M.D., Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012p001126
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Greater Trochanteric Pain Syndrome
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Foundation IRCCS San Matteo HospitalActive, not recruitingGreater Trochanteric Pain Syndrome of Both Lower LimbsItaly
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Lawson Health Research InstituteNot yet recruitingLow Back Pain | Greater Trochanteric Pain Syndrome
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Gazi UniversityCompletedGluteal Tendinitis | Greater Trochanteric Pain Syndrome of Both Lower LimbsTurkey
-
C.R.Darnall Army Medical CenterUnknownGreater Trochanteric Pain SyndromeUnited States
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Guna S.p.aTerminatedGreater Trochanteric Pain Syndrome | Pertrochanteric Fracture | Gluteal Tendinitis | GTPS - Greater Trochanteric Pain Syndrome | Tendon Disorder | Gluteal MusclesItaly
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NHS Greater Glasgow and ClydeNHS Research ScotlandRecruitingGreater Trochanteric Pain SyndromeUnited Kingdom
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Smith & Nephew, Inc.CompletedHip Pain Chronic | Greater Trochanteric Pain SyndromeAustralia
-
Kutahya Health Sciences UniversityRecruitingGreater Trochanteric Pain SyndromeTurkey
-
Royal College of Surgeons, IrelandRecruitingGluteal Tendinopathy | Trochanteric Bursitis | Greater Trochanteric Pain SyndromeIreland
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Oslo University HospitalUniversity of Oslo; Fysiofondet; Oslo Metropolitan UniversityRecruitingGluteal Tendinopathy | Trochanteric Bursitis | Lateral Hip Pain | GTPS - Greater Trochanteric Pain SyndromeNorway