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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
July 11, 2012
July 17, 2012
April 14, 2015
June 2012
August 2015   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01642043 on ClinicalTrials.gov Archive Site
  • 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
  • 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 [ 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 [ Time Frame: Baseline ]
    • Duration of pain
    • Body Mass Index
    • Physical exam findings
    • Treatments tried in the past
    • Presence of back pain
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Outpatient rheumatology clinic
Greater Trochanteric Pain Syndrome
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01642043
2012p001126
No
Not Provided
Not Provided
Minna Jean Kohler, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Minna J. Kohler, M.D. Massachusetts General Hospital
Massachusetts General Hospital
April 2015