Clinical trial NCT01642043: Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome
Official title: Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome (GTPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Greater Trochanteric Pain Syndrome
Keywords: greater trochanteric pain syndrome
trochanteric bursitis
lateral hip pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient rheumatology clinic

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.

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 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

Primary outcomes:
measure: Descriptive diagnostic ultrasound findings of the bony and soft tissue structures of the lateral hip and iliotibial band
timeFrame: Baseline
Secondary outcomes:
measure: Pain with rest measured by a numeric rating scale
timeFrame: Baseline and 2 weeks
measure: Pain with activity as measured by a numeric rating scale
timeFrame: Baseline and 2 weeks
measure: Demographics- composite
timeFrame: Baseline
measure: Pressure point threshold as measured by an algometer
timeFrame: Baseline
measure: Clinical data: Predictors of treatment response- composite
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Minna J. Kohler, M.D.
role: PRINCIPAL_INVESTIGATOR
References: