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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of steroid injections to determine which is more effective for treating De Quervain's syndrome, a condition causing pain at the base of the thumb. One group will receive an intra-sheath injection (directly into the affected area), while the other will receive an extra-sheath injection (around the area). Researchers will assess participants' pain levels before and six weeks after the injection to determine which method is more effective. The trial seeks individuals diagnosed with De Quervain's syndrome who have not undergone previous treatments like surgery or injections for this condition and who experience significant pain. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

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 is the safety track record for these treatments?

Research has shown that steroid injections for De Quervain's Syndrome are generally safe. Most side effects are minor and resolve on their own, while serious side effects are rare. Studies have found that injections given outside the tendon sheath help reduce symptoms and improve hand function. Research indicates that injections given inside the tendon sheath effectively treat the condition. However, some patients required additional injections, and symptoms could return within a year. Overall, both types of injections are well-tolerated with minimal risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the new steroid injection techniques for De Quervain's Syndrome because they offer a fresh approach to delivering treatment. Traditionally, corticosteroid injections for this condition are administered into the tendon sheath, but this study explores two innovative methods: intra-sheath and extra-sheath injections. The intra-sheath injection delivers corticosteroids directly into the tendon sheath, which could enhance precision and effectiveness. On the other hand, the extra-sheath injection surrounds the sheath, potentially minimizing side effects while still targeting the inflamed area. These methods might improve treatment outcomes by offering more targeted and potentially less intrusive alternatives to current options.

What evidence suggests that this trial's treatments could be effective for De Quervain's Syndrome?

This trial will compare two types of steroid injections for treating De Quervain's tenosynovitis: intra-sheath and extra-sheath injections. Research has shown that both types, administered inside or outside the tendon sheath, are effective. Participants in the intra-sheath arm will receive injections directly into the sheath, which studies have found provide significant relief for many patients. Meanwhile, those in the extra-sheath arm will receive injections surrounding the sheath, which also work well, with many patients experiencing less pain and better hand function. Specifically, some research indicates that 73.9% of patients who received ultrasound-guided steroid injections reported their symptoms resolved. Both methods offer a good chance of pain relief and improved hand use for those with this condition. ^{1 2 3 5 6}

Who Is on the Research Team?

Christopher O Bayne, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4655850/

The Effectiveness of Corticosteroid Injection for De Quervain's ... This review confirms that corticosteroid injection results in an increase in the resolution of symptoms, increased pain relief and increase in function

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04895956

Intra-sheath vs Extra-sheath Injection for De Quervain's ... Null Hypothesis: Extra-sheath steroid injections are inferior to intra-sheath steroid injections in the treatment of DeQuervain's tenosynovitis. Alternative ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811119

Management of de Quervain Tenosynovitis: A Systematic ... Administering the corticosteroid injection using ultrasonographic guidance was associated with greater pain reduction than conventional ...

4. journals.lww.com journals.lww.com/mjdy/fulltext/2025/05000/efficacy_of_local_steroid_injection_versus_first.6.aspx

Efficacy of Local Steroid Injection Versus First Extensor... We compared the efficacy of local steroid injection versus first extensor compartment decompression in the treatment of de Quervain's tenosynovitis.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jmrs.681

Unblinding de Quervain: A systematic review of ultrasound ... Of 379 total wrists treated with ultrasound-guided corticosteroid injections, 73.9% (n = 280) reported complete resolution of symptoms, 18.2% (n ...

6. withpower.com withpower.com/trial/phase-de-quervain-disease-8-2021-f7789

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 ...