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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01642043
Other study ID # 2012p001126
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date August 2015

Study information

Verified date August 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain with rest measured by a numeric rating scale Baseline and 2 weeks
Secondary Pain with activity as measured by a numeric rating scale Baseline and 2 weeks
Secondary Demographics- composite age, gender, race/ethnicity, education, occupation, comorbidities, overall health status. Baseline
Secondary Pressure point threshold as measured by an algometer Baseline
Secondary Clinical data: Predictors of treatment response- composite Duration of pain
Body Mass Index
Physical exam findings
Treatments tried in the past
Presence of back pain
Baseline
See also
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