Injection SiteNCT03147118
Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis
An observational study of Injection Site and Arthritis;Hand/Finger(S), run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. The importance of this study is one of education, cost containment, and decreased risk to the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injection Site, Arthritis;Hand/Finger(S)
- What is being tested?
- Arthrogram
- Type of treatment
- Injection or infusion
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 15 Sep 2017
- 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: All patients diagnosed with trapeziometacarpal arthritis and a treatment plan including intra-articular steroid injections
Who may be able to join
- The patient has clinical signs of trapeziometacarpal arthritis and are willing to obtain a post injection x-ray
- The patient is over the age of 18 years of age.
Who cannot join
- The patient has a known allergy to contrast dye
- The patient has a planned surgery on the trapeziometacarpal joint within 6 weeks following injection
- Patients who are pregnant or believe they may be pregnant
- Prisoners
- Patients who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. The importance of this study is one of education, cost containment, and decreased risk to the patient. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then these guided techniques may not be needed.
Read the detailed description
The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then fluoroscopy and ultrasound guided techniques may not be needed. Due to the expenses associated with medications and testing, it is important to not accrue unnecessary costs if there is no perceived benefit. The investigators plan to enroll 50 patients presenting with trapeziometacarpal joint arthritis who agree to participate. These participants will undergo an injection technique consisting of palpating the base of the thumb and placing the needle into the trapeziometacarpal joint without the guidance of ultrasound or fluoroscopy. Contrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 fluoroscopy views of the thumb. The images will not be evaluated for injection accuracy prior to the patient leaving the clinic, so as to not introduce any bias by the treating physician. These images will be blindly reviewed by three investigators at a later date, and determined by consensus if there is contrast material in the joint. The accuracy rate can then be compared to data regarding accuracy of fluoroscopic and ultrasound guided injections of the trapeziometacarpal joint. If there is a similar accuracy rate between modalities, it can be concluded that ultrasound may not be worth the added cost to the patient and fluoroscopy may not be worth the added cost or radiation to the participant. Additionally, participants will be contacted at 6 weeks post injection to evaluate post-injection arthritis symptoms.
- Conditions
- Injection Site, Arthritis;Hand/Finger(S)
- Being tested
- Arthrogram
- Keywords
- trapeziometacarpal arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrogramDiagnostic test
Contrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 radiograph views of the thumb.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of injection
Accuracy judged in a blinded fashion, rated injection in joint or out of joint
Measured: radiograph immediately after injection (<5 mins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 May 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection SiteStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Sanders, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147118
- Sponsor's protocol ID
- PRO00059888
- Status last verified
- Sep 2024
- First submitted
- 8 May 2017
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis
- ClinicalTrials.gov ID
- NCT03147118
- Acronym / sponsor ID
- PRO00059888
- Conditions
- Injection Site, Arthritis;Hand/Finger(S)
- Keywords
- trapeziometacarpal arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 10 May 2017 (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.
The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. The importance of this study is one of education, cost containment, and decreased risk to the patient. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then these guided techniques may not be needed.
Detailed description
The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then fluoroscopy and ultrasound guided techniques may not be needed. Due to the expenses associated with medications and testing, it is important to not accrue unnecessary costs if there is no perceived benefit. The investigators plan to enroll 50 patients presenting with trapeziometacarpal joint arthritis who agree to participate. These participants will undergo an injection technique consisting of palpating the base of the thumb and placing the needle into the trapeziometacarpal joint without the guidance of ultrasound or fluoroscopy. Contrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 fluoroscopy views of the thumb. The images will not be evaluated for injection accuracy prior to the patient leaving the clinic, so as to not introduce any bias by the treating physician. These images will be blindly reviewed by three investigators at a later date, and determined by consensus if there is contrast material in the joint. The accuracy rate can then be compared to data regarding accuracy of fluoroscopic and ultrasound guided injections of the trapeziometacarpal joint. If there is a similar accuracy rate between modalities, it can be concluded that ultrasound may not be worth the added cost to the patient and fluoroscopy may not be worth the added cost or radiation to the participant. Additionally, participants will be contacted at 6 weeks post injection to evaluate post-injection arthritis symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with trapeziometacarpal arthritis and a treatment plan including intra-articular steroid injections
Key inclusion criteria (2 listed)
- The patient has clinical signs of trapeziometacarpal arthritis and are willing to obtain a post injection x-ray
- The patient is over the age of 18 years of age.
Key exclusion criteria (5 listed)
- The patient has a known allergy to contrast dye
- The patient has a planned surgery on the trapeziometacarpal joint within 6 weeks following injection
- Patients who are pregnant or believe they may be pregnant
- Prisoners
- Patients who are unable to provide informed consent
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 |
|---|---|---|
| ArthrogramContrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 radiograph views of the thumb. | Diagnostic test | – |
Primary outcome
Accuracy of injection
Time frame: radiograph immediately after injection (<5 mins)
Accuracy judged in a blinded fashion, rated injection in joint or out of joint
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 24 Sep 2024.
- 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.
John Sanders, MD principal investigator
Prisma Health-Upstate
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 Injection Site and Arthritis;Hand/Finger(S), run by Prisma Health-Upstate 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 2 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 24 Sep 2024. 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?
Accuracy of injection (time frame: radiograph immediately after injection (<5 mins)). 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 24 Sep 2024.