NCT01642043

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

July 11, 2012

Last Update Submit

August 24, 2022

Conditions

Keywords

greater trochanteric pain syndrometrochanteric bursitislateral hip pain

Outcome Measures

Primary Outcomes (1)

  • Descriptive diagnostic ultrasound findings of the bony and soft tissue structures of the lateral hip and iliotibial band

    Presence of tendinopathy, tendon tears, bursitis, enthesophytes, calcifications

    Baseline

Secondary Outcomes (5)

  • Pain with rest measured by a numeric rating scale

    Baseline and 2 weeks

  • Pain with activity as measured by a numeric rating scale

    Baseline and 2 weeks

  • Demographics- composite

    Baseline

  • Pressure point threshold as measured by an algometer

    Baseline

  • Clinical data: Predictors of treatment response- composite

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient rheumatology clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Minna J. Kohler, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Musculoskeletal Ultrasound- Division of Rheumatology, Allergy, and Immunology

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 17, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations