Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis

Injection Site Clinical Trial

Official title:

Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147118
• Other study ID #: PRO00059888
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: September 15, 2017

Study information

• Verified date: August 2018
• Source: Greenville Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis;Hand/Finger(S)
• Injection Site

Intervention

Diagnostic Test:
• Arthrogram
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.

Locations

Country	Name	City	State
United States	The Hand Center	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Greenville Health System	American Foundation for Surgery of the Hand

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of injection	Accuracy judged in a blinded fashion, rated injection in joint or out of joint	radiograph immediately after injection (<5 mins)