Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Minna Jean Kohler, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01642043
First received: July 11, 2012
Last updated: April 7, 2014
Last verified: April 2014

July 11, 2012
April 7, 2014
June 2012
May 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Pain with activity as measured by a numeric rating scale [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
  • Demographics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    age, gender, race/ethnicity, education, occupation, comorbidities, overall health status.
  • Pressure point threshold as measured by an algometer [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Clinical data: Predictors of treatment response [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    • Duration of pain
    • Body Mass Index
    • Physical exam findings
    • Treatments tried in the past
    • Presence of back pain
Same as current
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.
 
Recruiting
120
June 2015
May 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
Both
18 Years and older
No
Contact: Naina Rastalsky, M.D. 617-726-7938 nrastalsky1@partners.org
Contact: Minna Kohler, M.D. 617-726-7938 mkohler@partners.org
United States
 
NCT01642043
2012p001126
No
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 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP