Adults 18 to 95, any sex, with Tenosynovitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone GroupPrimary· Pre injection, Post injection day, 2 weeks and at 6 weeks
Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants.
Pre-Injection: How painful do you think the injection will be?
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
5.9
± 2.3
Control Group (Corticosteroid Alone)
5.4
± 2.6
Pre-Injection: How painful do you think it will be 1-minute after the injection?
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
4.4
± 2.6
Control Group (Corticosteroid Alone)
3.2
± 2.7
Pre-Injection: How nervous are you about the injection?
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
4.0
± 3.5
Control Group (Corticosteroid Alone)
3.5
± 3.3
Post-Injection: Actual pain of the needle
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
4.3
± 3.1
Control Group (Corticosteroid Alone)
4.2
± 2.9
Post-Injection: Actual pain of the medication
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
4.7
± 3.2
Control Group (Corticosteroid Alone)
4.3
± 2.8
Post-Injection: Actual pain 1-minute after the injection
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
1.7
± 2.2
Control Group (Corticosteroid Alone)
1.7
± 2.2
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7Primary· Post injection day (1-7), 2 weeks and at 6 weeks post intervention
Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented.
Post injection day 1
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
3.7
± 2.2
Control Group (Corticosteroid Alone)
3.7
± 3.0
Post injection day 2
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
2.2
± 2.0
Control Group (Corticosteroid Alone)
3.0
± 2.9
Post injection day 3
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
1.7
± 1.9
Control Group (Corticosteroid Alone)
2.6
± 2.6
Post injection day 4
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
1.1
± 1.5
Control Group (Corticosteroid Alone)
2.2
± 2.0
Post injection day 5
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
1.0
± 1.4
Control Group (Corticosteroid Alone)
2.0
± 2.2
Post injection day 6
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
0.69
± 1.1
Control Group (Corticosteroid Alone)
1.5
± 1.8
Post injection day 7
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
0.58
± 0.95
Control Group (Corticosteroid Alone)
1.6
± 1.9
Number of Patients With Subsequent Reinjection and Surgical OperationPrimary· End of follow up (6 weeks post intervention)
The number of patients with subsequent reinjection and surgical operation was collected during follow up.
Group
Value
95% CI
Treatment Group (Corticosteroid Injection Plus Lidocaine)
0
Control Group (Corticosteroid Alone)
0
Sponsor's own description
The clinical trial is a randomized control trial to compare the efficacy of a combined lidocaine and corticosteroid (CS) injection versus a corticosteroid injection (CS) alone on pain, range of motion, and patient reported outcomes for the treatment of common upper extremity tendinopathies and nerve entrapments that are often treated with a combination of these injectates.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 12 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03704584.