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

NCT07043179 | Not Yet Recruiting

• 1 other identifier: 2025-KY-097
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Outcome Measures

Primary Outcomes (1)

• Surgical rate within 52 weeks

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

  52 weeks

Secondary Outcomes (6)

• Change from baseline in BCTQ symptom severity subscale

  0,6,12,24,52 weeks

• Change from baseline in BCTQ function status subscale

  0,6,12,24,52 weeks

• Change from baseline of EQ-VAS

  0,6,12,24,52 weeks

• Change from baseline of PSQI

  0,6,12,24,52 weeks

• Change from baseline of the cross-sectional area of the median nerve

  0,52 weeks

Study Arms (3)

Nighttime splinting

OTHER

Wear a wrist neutral position splint at night for 6 weeks as the initial treatment.

Device: Nighttime Splinting; Other: Evaluation and Dynamic Adjustment

Corticosteroid injection

OTHER

Local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.

Drug: Corticosteroid Injection; Other: Evaluation and Dynamic Adjustment

Combination

OTHER

Nighttime splinting for 6 weeks combined with local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.

Device: Nighttime Splinting; Drug: Corticosteroid Injection; Other: Evaluation and Dynamic Adjustment

Interventions

Nighttime Splinting DEVICE

Nighttime splinting for 6 weeks.

Also known as: Wrist Splint

Combination; Nighttime splinting

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.

Also known as: Steroid Injection

Combination; Corticosteroid 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.

Combination; Corticosteroid injection; Nighttime splinting

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yun Qian: lead
• Shanghai 6th People's Hospital: collaborator

Study Sites (3)

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

Jinjiang, Fujian, China

Location

Yancheng Third People's Hospital

Yancheng, Jiangsu, China

Location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Adrenal Cortex Hormones; Steroids

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Jiaqi Su

CONTACT

86 21 64369181; sjqjswy@foxmail.com

Yun Qian

CONTACT

86 21 64369181; sakio@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: June 29, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)