Clinical trial NCT03147118: Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis
Official title: Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injection Site
Arthritis;Hand/Finger(S)
Keywords: trapeziometacarpal arthritis
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with trapeziometacarpal arthritis and a treatment plan including intra-articular steroid injections

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Accuracy of injection
timeFrame: radiograph immediately after injection (<5 mins)
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: The Hand Center
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: John Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References: