Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis

NCT04895956 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1618614
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

De Quervain Tenosynovitis

Keywords

Steroid injection

Outcome Measures

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.

  6 weeks

Secondary Outcomes (6)

• Visual analog scale (VAS) at 6 months post injection

  6 months

• Visual analog scale (VAS) at 1 year post injection

  1 year

• Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 week post injection

  6 weeks

• Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 months post injection

  6 months

• Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 1 year post injection

  1 year

Study Arms (2)

Intra-sheath injection

ACTIVE COMPARATOR

In patients randomized to the intra-sheath, corticosteroids will be injected directly into the abductor pollicis longus/ extensor pollicis brevis sheath.

Procedure: Intra-sheath injection; Device: Ultrasound

Extra-sheath injection

EXPERIMENTAL

In patients randomized to the extra-sheath arm, corticosteroids will be injected surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.

Procedure: Extra-sheath injection; Device: Ultrasound

Interventions

Intra-sheath injection PROCEDURE

Ultrasound 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.

Intra-sheath injection

Extra-sheath injection PROCEDURE

Ultrasound 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.

Extra-sheath injection

Ultrasound DEVICE

To 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

Extra-sheath injection; Intra-sheath injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Underlying serious medical conditions that would place the patient at risk
• Past history of hypothyroidism or rheumatoid arthritis
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health, Department of Orthopaedics

Sacramento, California, 95817, United States

RECRUITING

Related Publications (14)

• Rowland P, Phelan N, Gardiner S, Linton KN, Galvin R. The Effectiveness of Corticosteroid Injection for De Quervain's Stenosing Tenosynovitis (DQST): A Systematic Review and Meta-Analysis. Open Orthop J. 2015 Sep 30;9:437-44. doi: 10.2174/1874325001509010437. eCollection 2015.

  PMID: 26587059 BACKGROUND

• Ilyas AM, Ast M, Schaffer AA, Thoder J. De quervain tenosynovitis of the wrist. J Am Acad Orthop Surg. 2007 Dec;15(12):757-64. doi: 10.5435/00124635-200712000-00009.

  PMID: 18063716 BACKGROUND

• Scheller A, Schuh R, Honle W, Schuh A. Long-term results of surgical release of de Quervain's stenosing tenosynovitis. Int Orthop. 2009 Oct;33(5):1301-3. doi: 10.1007/s00264-008-0667-z. Epub 2008 Oct 28.

  PMID: 18956185 BACKGROUND

• Richie CA 3rd, Briner WW Jr. Corticosteroid injection for treatment of de Quervain's tenosynovitis: a pooled quantitative literature evaluation. J Am Board Fam Pract. 2003 Mar-Apr;16(2):102-6. doi: 10.3122/jabfm.16.2.102.

  PMID: 12665175 BACKGROUND

• McDermott JD, Ilyas AM, Nazarian LN, Leinberry CF. Ultrasound-guided injections for de Quervain's tenosynovitis. Clin Orthop Relat Res. 2012 Jul;470(7):1925-31. doi: 10.1007/s11999-012-2369-5. Epub 2012 May 3.

  PMID: 22552767 BACKGROUND

• Oh JK, Messing S, Hyrien O, Hammert WC. Effectiveness of Corticosteroid Injections for Treatment of de Quervain's Tenosynovitis. Hand (N Y). 2017 Jul;12(4):357-361. doi: 10.1177/1558944716681976. Epub 2016 Dec 5.

  PMID: 28644946 BACKGROUND

• Taras JS, Raphael JS, Pan WT, Movagharnia F, Sotereanos DG. Corticosteroid injections for trigger digits: is intrasheath injection necessary? J Hand Surg Am. 1998 Jul;23(4):717-22. doi: 10.1016/S0363-5023(98)80060-9.

  PMID: 9708388 BACKGROUND

• Mardani-Kivi M, Karimi-Mobarakeh M, Babaei Jandaghi A, Keyhani S, Saheb-Ekhtiari K, Hashemi-Motlagh K. Intra-sheath versus extra-sheath ultrasound guided corticosteroid injection for trigger finger: a triple blinded randomized clinical trial. Phys Sportsmed. 2018 Feb;46(1):93-97. doi: 10.1080/00913847.2018.1400897. Epub 2017 Nov 10.

  PMID: 29125382 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006 May 18;7:44. doi: 10.1186/1471-2474-7-44.

  PMID: 16709254 BACKGROUND

• Changulani M, Okonkwo U, Keswani T, Kalairajah Y. Outcome evaluation measures for wrist and hand: which one to choose? Int Orthop. 2008 Feb;32(1):1-6. doi: 10.1007/s00264-007-0368-z. Epub 2007 May 30.

  PMID: 17534619 BACKGROUND

• Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.

  PMID: 11382253 BACKGROUND

• Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.

  PMID: 19535272 BACKGROUND

• Brinks A, Koes BW, Volkers AC, Verhaar JA, Bierma-Zeinstra SM. Adverse effects of extra-articular corticosteroid injections: a systematic review. BMC Musculoskelet Disord. 2010 Sep 13;11:206. doi: 10.1186/1471-2474-11-206.

  PMID: 20836867 BACKGROUND

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

De Quervain Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Christopher O Bayne, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Martin, MS

CONTACT

916-7348175; jyhmartin@ucdavis.edu

Christopher O Bayne, MD

CONTACT

(916) 734-2700; cbayne@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will not be informed which arm of the trial they have been placed in until after the conclusion of their involvement with the study. To ensure blinding of the physicians, follow up assessments will not be performed by the doctors who administered the injection and will instead be performed by residents who will not be informed which group the patient has been placed in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will be a double blinded randomized controlled trial with half of the subjects randomized to receive intra-sheath injection and the other half receiving extra-sheath injection.

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 21, 2021
• Study Start: January 24, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon first patient enrollment, until completion of data analysis, likely at 2 years.
• Access Criteria: Completed HIPAA and human subjects research training as enforced by University of California, Davis, and included as a participant of the study.

Locations

US (1)