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NCT Number: NCT07043179

Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome

The goal of this clinical trial is to compare the efficacy of corticosteroid injection, night splinting, and their combined use as initial treatments for adults with moderate to severe carpal tunnel syndrome (CTS), and to assess the safety and tolerability of these interventions. The primary research questions include:

* Doe corticosteroid injection, night splinting, and their combined use as initial treatments reduce the need for surgery in participants with moderate to severe CTS? * How do these interventions affect the improvement of patient symptoms?

Participants will:

* Receive corticosteroid injection, night splinting, or their combination as initial treatments. * Visit the clinic once every 6 weeks over a period of one year for assessments and dynamic adjustment of the treatment plan. * Undergo periodic assessments of wrist function, quality of life, and sleep quality using standardized questionnaires.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinjiang Municipal Hospital(Shanghai Sixth People's Hospital Fujian Campus), Jinjiang, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged no less than 18 years old with idiopathic carpal tunnel syndrome of the target side diagnosed by a specialist according to the Katz diagnostic criteria;
  • The current episode has occurred within 6 weeks without treatment before eligibility assessment, and the target side has moderate-to-severe symptoms.

Exclusion criteria

  • Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
  • Any secodary CTS caused by comorbid diseases, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.;
  • History of fracture or surgery on the target side of the wrist;
  • Bilateral CTS with moderate or severe symptoms in both hands;
  • Received corticosteroid injections in the wrist within the past 6 months;
  • Patients who are unable to wear a splint due to trauma or other reasons;
  • Patients with clinical manifestations or electrophysiological changes indicative of significant axonal loss or denervation, including thenar muscle atrophy, sensory loss (two-point discrimination greater than 8 mm), absence of SNAP (sensory nerve action potential), absence of CMAP (compound muscle action potential) in the thenar muscles, etc.;
  • Patients who require long-term use of any form of analgesic medication, such as NSAIDs (nonsteroidal anti-inflammatory drugs), opioids, acetaminophen, etc.;
  • Patients who have used NSAIDs, opioids (e.g., tramadol), neuropathic pain medications (gabapentin, pregabalin, etc.), or oral corticosteroids within the past 2 weeks;
  • Patients who have received non-recommended wrist injection treatments (e.g., 5% glucose, platelet-rich plasma, ozone, chitosan, hyaluronic acid, etc.) within the past 6 months;
  • Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months.

Treatment and study plan

Nighttime Splinting

Device

Nighttime splinting for 6 weeks.

Other names: Wrist Splint

Corticosteroid injection

Drug

Local corticosteroid injection (triamcinolone acetonide 40mg). A single injection of triamcinolone acetonide 40mg mixed with an equal volume of 1% lidocaine is administered. The injection is performed under ultrasound guidance and anatomical landmarks to target the proximal carpal tunnel. With the wrist extended, the needle is typically inserted on the ulnar side of the palmaris longus tendon, approximately 1 cm proximal to the wrist crease. If blood is aspirated or the patient reports paresthesia (which usually indicates nerve irritation), the injection site should be adjusted.

Other names: Steroid Injection

Evaluation and Dynamic Adjustment

Other

6 weeks later, all patients will undergo evaluation of their initial treatment. Further therapeutic decisions will be made based on physician assessment, including: continuing nighttime splinting, administering corticosteroid injections to patients who initially received only the splint, adding nighttime splinting for patients initially received only corticosteroid injections, and transitioning from nighttime splint use to continuous wear. Subsequently, evaluations will be conducted every 6 weeks, with dynamic adjustments to the treatment plan. Corticosteroid injections will be administered at least 24 weeks apart, and the second injection dosage may be adjusted based on the patient's condition, with a maximum dose of 80mg. Throughout the study period, physicians will perform electrophysiological examinations according to changes in patients' clinical status.

Primary outcomes

  1. Surgical rate within 52 weeks

    Time frame: 52 weeks

    Participants will be asked if they have undergone surgery for carpal tunnel syndrome in the last 52 weeks.

Secondary outcomes

  1. Change from baseline in BCTQ symptom severity subscale

    Time frame: 0,6,12,24,52 weeks

    Change from baseline in the score of the BCTQ symptom severity subscale (Boston Carpal Tunnel Questionnaire Symptom Severity subscale) will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.

  2. Change from baseline in BCTQ function status subscale

    Time frame: 0,6,12,24,52 weeks

    Change from baseline in the score of the BCTQ function status subscale (Boston Carpal Tunnel Questionnaire Function Status Subscale) will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.

  3. Change from baseline of EQ-VAS

    Time frame: 0,6,12,24,52 weeks

    The EQ-VAS is a measure of the overall health of respondents on the day of the survey. Change from baseline in the score of EQ-VAS will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.

  4. Change from baseline of PSQI

    Time frame: 0,6,12,24,52 weeks

    The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality. Change from baseline in the score of the PSQI will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.

  5. Change from baseline of the cross-sectional area of the median nerve

    Time frame: 0,52 weeks

    The median nerve cross-sectional area will be measured with musculoskeletal ultrasound. Change from baseline of the cross-sectional area will be compared at 52 weeks follow-up.

  6. The incidence rate of clinical and electrophysiological changes indicative of new-onset axonal loss or denervation within 52 weeks

    Time frame: 52 weeks

    Researchers will assess and record whether there are any new clinical or electrophysiological changes indicating axonal loss or denervation during follow-up. The incidence rates of these changes in different treatment groups will be compared at the 52-week follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaqi Su

CONTACT

[email protected]

86 21 64369181

Yun Qian

CONTACT

[email protected]

86 21 64369181

Sponsors and collaborators

Lead sponsor

Yun Qian

Other

Collaborators

  • Shanghai 6th People's Hospital

Registry information

Official study title

Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome: A Pragmatic, Three-Armed, Open-Label, Multicenter, Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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