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
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ 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


Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642043

Contacts
Contact: Naina Rastalsky, M.D. 617-726-7938 nrastalsky1@partners.org
Contact: Minna Kohler, M.D. 617-726-7938 mkohler@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Naina Rastalsky, M.D.    617-726-7938      
Contact: Minna Kohler, M.D.    617-726-7938      
Principal Investigator: Minna J. Kohler, M.D.         
Sub-Investigator: Naina Rastalsky, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Minna J. Kohler, M.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

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
Study First Received: July 11, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
greater trochanteric pain syndrome
trochanteric bursitis
lateral hip pain

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

ClinicalTrials.gov processed this record on October 29, 2014