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Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Minna Jean Kohler, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642043
First Posted: July 17, 2012
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Minna Jean Kohler, Massachusetts General Hospital
  Purpose

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.


Condition
Greater Trochanteric Pain Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome (GTPS)

Resource links provided by NLM:


Further study details as provided by Minna Jean Kohler, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Pain with rest measured by a numeric rating scale [ Time Frame: Baseline and 2 weeks ]
  • Pain with activity as measured by a numeric rating scale [ Time Frame: Baseline and 2 weeks ]
  • Demographics- composite [ Time Frame: Baseline ]
    age, gender, race/ethnicity, education, occupation, comorbidities, overall health status.

  • Pressure point threshold as measured by an algometer [ Time Frame: Baseline ]
  • Clinical data: Predictors of treatment response- composite [ Time Frame: Baseline ]
    • Duration of pain
    • Body Mass Index
    • Physical exam findings
    • Treatments tried in the past
    • Presence of back pain


Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient rheumatology clinic
Criteria

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
  Contacts and Locations
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): NCT01642043


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Minna J. Kohler, M.D. Massachusetts General Hospital
  More Information

Additional Information:
Responsible Party: Minna Jean Kohler, Director, Musculoskeletal Ultrasound- Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01642043     History of Changes
Other Study ID Numbers: 2012p001126
First Submitted: July 11, 2012
First Posted: July 17, 2012
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Minna Jean Kohler, Massachusetts General Hospital:
greater trochanteric pain syndrome
trochanteric bursitis
lateral hip pain

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders


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