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

September 13, 2023 updated by: University of California, Davis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Null Hypothesis: Extra-sheath steroid injections are inferior to intra-sheath steroid injections in the treatment of DeQuervain's tenosynovitis.

Alternative Hypothesis:Extra-sheath steroid injections are not inferior to intra-sheath steroid injections in the treatment of De Quervain's tenosynovitis.

Background:

DeQuervain's Tenosynovitis is a common condition with an estimated incidence of 0.5% in men and 1.3% in women, usually occurring in the third or fourth decade of life. The condition involves accumulation of mucopolysaccharide in the first dorsal compartment of the wrist, narrowing the passageway through which the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons pass(1). Patients typically present with pain over the radial styloid that is often exacerbated by grasping, thumb abduction and ulnar deviation of the wrist. The degree of pain can be measured using the visual analog scale (VAS).

The VAS 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.

Currently the most effective treatment modality for this condition is ultrasound guided injection of corticosteroids directly into the sheath where the APL and EPB pass. However, we hypothesize that injecting corticosteroids outside the sheath will not be inferior. Our rationale for this hypothesis lies in prior studies examining a similar approach for the treatment of the related condition, trigger finger. Two separate studies compared the efficacy of intra-sheath vs extra-sheath steroid injections in this condition and found that extra-sheath injections were as effective as intra-sheath injections in the treatment of trigger finger(7,8). These studies lay the groundwork for this approach in DeQuervain's, however, no clinical trials comparing the efficacy and safety of intra-sheath versus extra-sheath steroid injections for the treatment of DeQuervain's tenosynovitis have been reported to date.

Study Timelines:

Participants will be screened and enrolled at their clinic visit at UC Davis Health Center. Once the patient has qualified for the study, they will undergo either the intra-sheath or extra-sheath steroid injection. Patient's will return for follow-up appointments at 6 weeks, 6 months and 1 year post injection. We estimate a 2.5 year enrollment period, followed by a six-month data review period.

Power analysis:

This study is designed to determine whether extra-sheath steroid injection is similarly effective (i.e., noninferior) to intra-sheath steroid injection at improving pain. The study sample size will be determined on the basis of an expected standard deviation of 14mm in the primary outcome of pain improvement and a non-inferiority limit of 14mm. This expected standard deviation was derived from previous trials that examined the efficacy of steroid injections for DeQuervain's tenosynovitis (1). The non-inferiority boundary of 14mm was selected based on a previously calculated minimum clinically important difference (MCID) on the VAS pain scale of 14mm(5). The primary outcome of interest is the difference between pre-injection and 6 weeks post-injection VAS scores in each group. Assuming a non-inferiority test for the difference between two means, we find that a group sample size of 13 in the intra-sheath and 13 in extra-sheath steroid injection group achieves 80% power to detect non-inferiority using a one-sided two-sample t-test. The margin of non-inferiority is 14mm. The true difference between the means is assumed to be 0. The significance level (alpha) of the test is 0.050. The expected standard deviation is 14mm.

To ensure we have an adequate number of patients to achieve significance for secondary study endpoint analysis and allowing for a dropout rate of 15% we plan to enroll 80 patients.

Procedures Involved:

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. After signing consent, the inclusion and exclusion criteria will be reviewed. Eligible subjects will be enrolled and randomized into the study. The consenting researcher will use a digital Randomizer application ("Randomizer", available on all smart phones) to assign the individual to either intra-sheath injection group or extra sheath injection group. After being randomized, the study arm will be recorded at subject source document and Enrollment Log. The signed consent will be scanned into the patient's electronic medical record. The hard copy consents will be stored securely.

In both groups the injection will be ultrasound-guided and the injection solution will be composed of 1ml of 1% lidocaine and 1ml (20mg) of dexamethasone.

Patients randomized to the intra-sheath injection group will have all fluid injected directly into the APL/EPB sheath. In this group of patients, if subcompartments are found upon ultrasound inspection half of the solution will be deposited into the APL sheath and the other half will be deposited into the EPB subsheath, as previously described(5).

In patients randomized to the extra-sheath injection group, the injection will be given surrounding the sheath.

In both groups, pain will be measured using the visual analog scale (VAS) and symptoms/disability will be measured using the shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (quickDASH).

The 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.

All results, including which group the patient was randomized to will be recorded and input into the appropriate spreadsheet.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health, Department of Orthopaedics
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intra-sheath injection
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
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.
Device: Ultrasound
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
Experimental: Extra-sheath injection
In patients randomized to the extra-sheath arm, corticosteroids will be injected surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
Device: Ultrasound
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
Procedure: Extra-sheath injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS) at 6 weeks post injection
Time Frame: 6 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS) at 6 months post injection
Time Frame: 6 months

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.
6 months
Visual analog scale (VAS) at 1 year post injection
Time Frame: 1 year

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.
1 year
Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 week post injection
Time Frame: 6 weeks

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.
6 weeks
Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 months post injection
Time Frame: 6 months

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.
6 months
Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 1 year post injection
Time Frame: 1 year

The difference between pre-injection and 1 year 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.
1 year
Presence or absence of separate abductor pollicis longus and extensor pollicis brevis subsheaths
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Christopher O Bayne, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1618614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Correspondence of participants, their status in the study and the VAS and quickDASH scores will be shared through an encrypted excel document within an encrypted OneDrive sharing folder with a link that is personally sent to the participants of the study.

IPD Sharing Time Frame

Upon first patient enrollment, until completion of data analysis, likely at 2 years.

IPD Sharing Access Criteria

Completed HIPAA and human subjects research training as enforced by University of California, Davis, and included as a participant of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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