Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
ConditionDe Quervain Tenosynovitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
The aim of the study is to determine whether or not extra-sheath steroid injections are inferior to intra-sheath steroid injections in the treatment of DeQuervain's Tenosynovitis.
Patients will be randomized to either the intra-sheath group or the extra-sheath group and their pre-injection level of pain will be assessed using the visual analog scale. Appropriate injections will then be administered by 1 of 3 UC Davis hand surgeons. Six weeks post injection the patients will be reassessed using the visual analog scale and their score at 6 weeks will be compared to their pre-injection score.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent from the patient exclusively and not a legal representative
Clinically diagnosed with De Quervain's
VAS score of at least 40mm pre-injection
Life expectancy greater than 1 year
Disqualifiers
Having previously undergone steroid injection in the treatment of De Quervain's
Having previously undergone surgery for De Quervain's in the affected wrist
Having previously undergone steroid injection and failed in the treatment of trigger finger
Allergies to lidocaine or dexamethasone
Trial design
Design model
Parallel
Treatments tested in this trial
Intra-sheath injection
Procedure/SurgeryUltrasound guided corticosteroid injection composed of 1ml of 1% lidocaine and 1ml (20mg) of dexamethasone. Injection will be administered directly into the abductor pollicis longus/ extensor pollicis brevis sheath.
Extra-sheath injection
Procedure/SurgeryUltrasound guided corticosteroid injection composed of 1ml of 1% lidocaine and 1ml (20mg) of dexamethasone. Injection will be administered surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
Ultrasound
DeviceTo ensure accuracy of fluid deposition into the tendon sheath in the intra-sheath injection arm and outside of the tendon sheath in the extra-sheath injection arm, all injections will be performed under ultrasound guidance. The ultrasound machine used will be a portable ultrasound machine located at the UC Davis orthopaedic clinic in Sacramento
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intra-sheath injectionActive comparator 2 interventions
Group B: Extra-sheath injectionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Visual analog scale (VAS) at 6 weeks post injection
The difference between pre-injection and 6 weeks post-injection visual analog scale scores in both the experimental extra-sheath injection and control intra-sheath injection. The visual analog pain scale is a widely used test to effectively measure pain(9). The visual analog scale we will be using is a 100mm horizontal line with no numbers and only written descriptors on either end of the line. The written descriptor on the left side of the line will be "no pain" and the descriptor on the right will be "pain as bad as it could possibly be". Patients will be instructed to make a mark on the line where they believe their current pain fits. The patient's response will be measured and recorded.
Time frame
6 weeksSecondary outcomes
1
Visual analog scale (VAS) at 6 months post injection
The difference between pre-injection and 6 months post-injection visual analog scale scores in both the experimental extra-sheath injection and control intra-sheath injection. The visual analog pain scale is a widely used test to effectively measure pain(9). The visual analog scale we will be using is a 100mm horizontal line with no numbers and only written descriptors on either end of the line. The written descriptor on the left side of the line will be "no pain" and the descriptor on the right will be "pain as bad as it could possibly be". Patients will be instructed to make a mark on the line where they believe their current pain fits. The patient's response will be measured and recorded.
Time frame
6 months2
Visual analog scale (VAS) at 1 year post injection
The difference between pre-injection and 1 year post-injection visual analog scale scores in both the experimental extra-sheath injection and control intra-sheath injection. The visual analog pain scale is a widely used test to effectively measure pain(9). The visual analog scale we will be using is a 100mm horizontal line with no numbers and only written descriptors on either end of the line. The written descriptor on the left side of the line will be "no pain" and the descriptor on the right will be "pain as bad as it could possibly be". Patients will be instructed to make a mark on the line where they believe their current pain fits. The patient's response will be measured and recorded.
Time frame
1 year3
Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 week post injection
The difference between pre-injection and 6 weeks post-injection quickDASH scores in both the experimental extra-sheath injection and control intra-sheath injection. The disabilities of the arm shoulder and hand (DASH) questionnaire is a 30 item test commonly administered to patients with upper extremity disorders that allows them to self-assess the level of disability/symptoms associated with their disorder(10). The shortened version (quickDASH) reduces the number of test questions from 30 to 11. There are 5 answer choices for each item of the test and 10 out of the 11 questions must be answered for the test to be considered valid. Based on the patients answers to the questions, a score between 0 (no disability) and 100 (severe disability) will be calculated.
Time frame
6 weeks4
Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 months post injection
The difference between pre-injection and 6 months post-injection quickDASH scores in both the experimental extra-sheath injection and control intra-sheath injection. The disabilities of the arm shoulder and hand (DASH) questionnaire is a 30 item test commonly administered to patients with upper extremity disorders that allows them to self-assess the level of disability/symptoms associated with their disorder(10). The shortened version (quickDASH) reduces the number of test questions from 30 to 11. There are 5 answer choices for each item of the test and 10 out of the 11 questions must be answered for the test to be considered valid. Based on the patients answers to the questions, a score between 0 (no disability) and 100 (severe disability) will be calculated.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov