Hip PainNCT05209399
Comparison of Ultrasound-guided Intraarticular Hip Injections With and Without Prior Local Anesthesia
A study testing Ultrasound guided injection in people with Hip Pain, run by University of Rochester at 1 site in United States.
Trial summary
In this single-center randomized controlled trial, subjects undergoing a first-time ultrasound-guided unilateral intraarticular hip injection will be randomized into one of two groups: hip injection with prior local anesthesia (With LA) or hip injection without prior local anesthesia (Without LA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Pain
- What is being tested?
- Ultrasound guided injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to 10 May 2023
- Phase
- Interventional
- 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
Who may be able to join
- patients undergoing a first-time ultrasound-guided unilateral intraarticular hip injection
- Subjects must be fluent in English
- Subject must be able to consent for themselves and mark pain levels on a visual analog scale.
Who cannot join
- previous intraarticular hip injection (to remove bias from prior injection experiences)
- prior surgery on the hip to be injected
- use of opioid medication on the day of or day before the procedure
- diabetes mellitus
- body mass index (BMI) greater than 40
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center Physical Medicine and Rehabilitation
Rochester, New York, 14618
About this study
Official title: Comparison of Ultrasound-guided Intraarticular Hip Injections With and Without Prior Local Anesthesia: a Randomized Controlled Trial
In this single-center randomized controlled trial, subjects undergoing a first-time ultrasound-guided unilateral intraarticular hip injection will be randomized into one of two groups: hip injection with prior local anesthesia (With LA) or hip injection without prior local anesthesia (Without LA). Visual analog scale (VAS) pain scores (0-100) will be collected after the local anesthesia injection (With LA group) and intraarticular hip injection (both groups). The primary outcome measure for comparison between the two groups will be VAS score for the intraarticular hip injection.
- Conditions
- Hip Pain
- Being tested
- Ultrasound guided injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided injectionProcedure or surgery
All intraarticular hip injections will be performed under real-time ultrasound guidance using a GE LOGIQ P9 ultrasound machine with a C1-5-RS 1-5 MHz curvilinear transducer (GE Healthcare, Chicago, IL, USA). For the procedure, patients will be placed in a supine position. The curvilinear transducer and ultrasound machine will be used to visualize the anterior aspect of the hip joint in a sagittal oblique plane. Sterile technique will be used to perform the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Hip injection with prior local anesthesia | Active comparator | Not described Receives: Procedure: Ultrasound guided injection |
| Hip injection without prior local anesthesia | Active comparator | Not described Receives: Procedure: Ultrasound guided injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pain score
A visual analog pain score will be collected. The scale of the score is 0-100 with 100 indicating more 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 posted26 Jan 2022
- Study start30 Jun 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip PainStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Society for Sports Medicine
- Responsible party
- Principal investigator, Rondy Lazaro, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209399
- Sponsor's protocol ID
- STUDY00006887
- Status last verified
- Jun 2023
- First submitted
- 12 Jan 2022
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lazaro RM, Smith JM, Bender N, Punreddy A, Barford N, Paul JH. Comparison of Pain With Ultrasound-Guided Intra-Articular Hip Injections With and Without Prior Subcutaneous Local Anesthesia. Clin J Sport Med. 2024 Jul 24;35(5):543-548. doi: 10.1097/JSM.0000000000001260.
PubMed 39046314
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Intraarticular Hip Injections With and Without Prior Local Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05209399
- Acronym / sponsor ID
- STUDY00006887
- Conditions
- Hip Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American Medical Society for Sports Medicine
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- 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.
In this single-center randomized controlled trial, subjects undergoing a first-time ultrasound-guided unilateral intraarticular hip injection will be randomized into one of two groups: hip injection with prior local anesthesia (With LA) or hip injection without prior local anesthesia (Without LA). Visual analog scale (VAS) pain scores (0-100) will be collected after the local anesthesia injection (With LA group) and intraarticular hip injection (both groups). The primary outcome measure for comparison between the two groups will be VAS score for the intraarticular hip injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip injection with prior local anesthesia | Active comparator | Procedure: Ultrasound guided injection |
| Hip injection without prior local anesthesia | Active comparator | Procedure: Ultrasound guided injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing a first-time ultrasound-guided unilateral intraarticular hip injection
- Subjects must be fluent in English
- Subject must be able to consent for themselves and mark pain levels on a visual analog scale.
Key exclusion criteria (5 listed)
- previous intraarticular hip injection (to remove bias from prior injection experiences)
- prior surgery on the hip to be injected
- use of opioid medication on the day of or day before the procedure
- diabetes mellitus
- body mass index (BMI) greater than 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided injectionAll intraarticular hip injections will be performed under real-time ultrasound guidance using a GE LOGIQ P9 ultrasound machine with a C1-5-RS 1-5 MHz curvilinear transducer (GE Healthcare, Chicago, IL, USA). For the procedure, patients will be placed in a supine position. The curvilinear transducer and ultrasound machine will be used to visualize the anterior aspect of the hip joint in a sagittal oblique plane. Sterile technique will be used to perform the procedure. | Procedure or surgery | Hip injection with prior local anesthesia, Hip injection without prior local anesthesia |
Primary outcome
mean pain score
Time frame: baseline
A visual analog pain score will be collected. The scale of the score is 0-100 with 100 indicating more pain.
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 27 Jun 2023.
- Derived from this study: PubMed 39046314Lazaro RM, Smith JM, Bender N, Punreddy A, Barford N, Paul JH. Comparison of Pain With Ultrasound-Guided Intra-Articular Hip Injections With and Without Prior Subcutaneous Local Anesthesia. Clin J Sport Med. 2024 Jul 24;35(5):543-548. doi: 10.1097/JSM.0000000000001260.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided injection in people with Hip Pain, run by University of Rochester 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 3 inclusion and 5 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 27 Jun 2023. 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?
mean pain score (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209399, which also lists 1 linked publication.
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 27 Jun 2023.