Greater Trochanteric Pain SyndromeNCT01642043
Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome
An observational study of Greater Trochanteric Pain Syndrome, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Greater Trochanteric Pain Syndrome
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient rheumatology clinic
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Greater Trochanteric Pain Syndrome
- Keywords
- greater trochanteric pain syndrome, trochanteric bursitis, lateral hip pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (5)
Pain with rest measured by a numeric rating scale
Measured: Baseline and 2 weeks
Pain with activity as measured by a numeric rating scale
Measured: Baseline and 2 weeks
Demographics- composite
age, gender, race/ethnicity, education, occupation, comorbidities, overall health status.
Measured: Baseline
Pressure point threshold as measured by an algometer
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Trochanteric Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minna Jean Kohler, Massachusetts General Hospital
- Investigators
- Minna J. Kohler, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642043
- Sponsor's protocol ID
- 2012p001126
- Status last verified
- Aug 2022
- First submitted
- 11 Jul 2012
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome (GTPS)
- ClinicalTrials.gov ID
- NCT01642043
- Acronym / sponsor ID
- 2012p001126
- Conditions
- Greater Trochanteric Pain Syndrome
- Keywords
- greater trochanteric pain syndrome, trochanteric bursitis, lateral hip pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient rheumatology clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive diagnostic ultrasound findings of the bony and soft tissue structures of the lateral hip and iliotibial band
Time frame: Baseline
Presence of tendinopathy, tendon tears, bursitis, enthesophytes, calcifications
5 secondary outcomes
Pain with rest measured by a numeric rating scale
Time frame: Baseline and 2 weeks
Pain with activity as measured by a numeric rating scale
Time frame: Baseline and 2 weeks
Demographics- composite
Time frame: Baseline
Pressure point threshold as measured by an algometer
Time frame: Baseline
Clinical data: Predictors of treatment response- composite
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minna J. Kohler, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Greater Trochanteric Pain Syndrome, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive diagnostic ultrasound findings of the bony and soft tissue structures of the lateral hip and iliotibial band (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.