Steroid Injections for De Quervain's Syndrome

Overseen By Julia Martin, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Davis

Disqualifiers: Hypothyroidism, Rheumatoid arthritis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of steroid injections for De Quervain's Syndrome?

Research shows that injecting steroids like triamcinolone directly into the tendon sheath is very effective for treating De Quervain's Syndrome, with an 89% success rate. Using ultrasound guidance to accurately place the injection can improve outcomes, especially when there are multiple compartments in the tendon sheath. ^{1 2 3 4 5}

Is it safe to use steroid injections for De Quervain's Syndrome?

Steroid injections for De Quervain's Syndrome are generally safe, with most adverse reactions being minor and self-limiting. Studies show that serious complications like tendon ruptures or infections are rare, and many patients report satisfaction with the treatment. ^{1 2 3 5 6}

What makes the steroid injection treatment for De Quervain's Syndrome unique?

The steroid injection treatment for De Quervain's Syndrome is unique because it involves precise injections into specific tendon sheaths, often guided by ultrasound, to target inflammation directly at the source. This method can be more effective than general treatments, as it allows for accurate delivery of the medication to the affected areas, especially when subcompartments are present. ^{1 2 3 4 7}

What is the purpose of 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.

Research Team

Christopher O Bayne, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for individuals with De Quervain's Tenosynovitis, who have a pain level of at least 40mm on the visual analog scale and expect to live more than a year. They must not have allergies to lidocaine or dexamethasone, no past wrist surgeries for this condition, no serious medical risks, and cannot be prisoners or pregnant.

Inclusion Criteria

I have been diagnosed with De Quervain's.

VAS score of at least 40mm pre-injection

Signed informed consent from the patient exclusively and not a legal representative

Exclusion Criteria

I have serious health issues that could make treatment risky.

I have had a steroid injection for De Quervain's.

I have had hypothyroidism or rheumatoid arthritis in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either intra-sheath or extra-sheath steroid injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

3 visits (in-person) at 6 weeks, 6 months, and 1 year

Data Review

Data collected during the trial is reviewed and analyzed

6 months

Treatment Details

Interventions

• Extra-sheath injection
• Intra-sheath injection

Trial Overview The study compares two methods of steroid injection treatment for De Quervain's Tenosynovitis: one directly into the tendon sheath (intra-sheath) and another outside it (extra-sheath). Patients will be randomly assigned to either group and their pain levels measured before and six weeks after treatment.

Participant Groups

Group I: Extra-sheath injection Experimental Treatment 2 Interventions

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

Group II: Intra-sheath injection Active Control 2 Interventions

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

Extra-sheath injection is already approved in United States, European Union for the following indications:

Approved in United States as Extra-sheath steroid injection for:

• De Quervain's Tenosynovitis

Approved in European Union as Extra-sheath corticosteroid injection for:

• De Quervain's Tenosynovitis

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

In a randomized controlled trial involving 48 high-resistance training individuals with persistent de Quervain tenosynovitis, the novel 4-point injection technique resulted in significantly better outcomes compared to the traditional 2-point technique, with more patients becoming symptom-free at various follow-up points.

After 52 weeks, 21 patients treated with the 4-point technique were symptom-free, while only 12 patients in the 2-point group achieved the same result, indicating that the 4-point technique may be a more effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved corticosteroid treatment of recalcitrant de Quervain tenosynovitis with a novel 4-point injection technique. Pagonis, T., Ditsios, K., Toli, P., et al.[2019]

In a study involving 36 patients with de Quervain's disease, an intra-sheath injection of triamcinolone combined with lidocaine showed an efficacy rate of 89%, with better results from a two-point injection technique compared to a one-point injection.

Despite some complications observed in 13 hands and recurrence in 10 hands, over 90% of patients reported satisfaction with the treatment, highlighting the effectiveness and acceptability of this injection method for managing de Quervain's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De Quervain's disease: efficacy of intra-sheath triamcinolone injection. Sawaizumi, T., Nanno, M., Ito, H.[2022]

Ultrasound guidance significantly improves the accuracy of steroid injections for de Quervain disease by allowing for precise identification and targeting of tendon sheath subcompartments in 50 patients studied.

Patients with subcompartments experienced better improvement when receiving two separate steroid injections compared to a single injection, highlighting the importance of tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Guided Ultrasound in the Treatment of De Quervain Tenosynovitis by Local Steroid Infiltration. Danda, RS., Kamath, J., Jayasheelan, N., et al.[2020]

In a study of 17 patients with De Quervain's disease, ultrasound-guided injection of a mixture of triamcinolone and bupivacaine resulted in significant symptomatic relief for 93.75% of participants, demonstrating its efficacy in treatment.

The procedure was found to be safe, with no immediate or delayed complications reported, and it effectively avoided common local complications associated with injections, such as fat atrophy and depigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided injection of triamcinolone and bupivacaine in the management of De Quervain's disease. Jeyapalan, K., Choudhary, S.[2021]

In a study of 73 patients with de Quervain's tenosynovitis, the combination of methylprednisolone acetate injection and a thumb spica cast resulted in an 86.5% success rate, significantly higher than the 36.1% success rate for casting alone.

While 40% of patients experienced temporary pain at the injection site, the benefits of the injection in improving outcomes suggest it is a valuable addition to treatment for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylprednisolone acetate injection plus casting versus casting alone for the treatment of de Quervain's tenosynovitis. Mehdinasab, SA., Alemohammad, SA.[2018]

In a study of 56 cases of De Quervain's tenosynovitis treated with methylprednisolone acetate, about 90% of patients found relief from symptoms, with 58% responding to a single injection and 33% needing multiple injections over a 4-year follow-up.

The treatment was safe, with no serious adverse reactions like tendon ruptures or infections reported, making methylprednisolone acetate the recommended first-line therapy for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of De Quervain's tenosynovitis with corticosteroids. A prospective study of the response to local injection. Anderson, BC., Manthey, R., Brouns, MC.[2019]

A study involving 50 patients with de Quervain disease found that US-guided steroid injections targeting only the extensor pollicis brevis (EPB) subcompartment are equally effective in reducing pain compared to injections targeting both the EPB and abductor pollicis longus (APL) subcompartments.

Injections into the EPB subcompartment alone resulted in fewer cases of skin hypopigmentation (33%) compared to injections into both subcompartments (67%), suggesting a potential reduction in complications when using a single-compartment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is a Steroid Injection in Both Compartments More Effective than an Injection in the Extensor Pollicis Brevis Subcompartment Alone in Patients with de Quervain Disease? A Randomized, Controlled Trial. Jung, HS., Baek, SH., Lee, JS.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improved corticosteroid treatment of recalcitrant de Quervain tenosynovitis with a novel 4-point injection technique. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

De Quervain's disease: efficacy of intra-sheath triamcinolone injection. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Role of Guided Ultrasound in the Treatment of De Quervain Tenosynovitis by Local Steroid Infiltration. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Ultrasound-guided injection of triamcinolone and bupivacaine in the management of De Quervain's disease. [2021]

5. Iran pubmed.ncbi.nlm.nih.gov

Methylprednisolone acetate injection plus casting versus casting alone for the treatment of de Quervain's tenosynovitis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of De Quervain's tenosynovitis with corticosteroids. A prospective study of the response to local injection. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Is a Steroid Injection in Both Compartments More Effective than an Injection in the Extensor Pollicis Brevis Subcompartment Alone in Patients with de Quervain Disease? A Randomized, Controlled Trial. [2023]