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

NCT ID: NCT07043179

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-07-15

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nighttime splinting

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

Group Type: OTHER

Nighttime Splinting

Intervention Type: DEVICE

Nighttime splinting for 6 weeks.

Evaluation and Dynamic Adjustment

Intervention Type: 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.

Corticosteroid injection

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

Group Type: OTHER

Corticosteroid Injection

Intervention Type: 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.

Evaluation and Dynamic Adjustment

Intervention Type: 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

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

Group Type: OTHER

Nighttime Splinting

Intervention Type: DEVICE

Nighttime splinting for 6 weeks.

Corticosteroid Injection

Intervention Type: 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.

Evaluation and Dynamic Adjustment

Intervention Type: 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.

Interventions

Nighttime Splinting

Nighttime splinting for 6 weeks.

Intervention Type: DEVICE

Corticosteroid Injection

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.

Intervention Type: DRUG

Evaluation and Dynamic Adjustment

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.

Intervention Type: OTHER

Other Intervention Names

Wrist Splint; Steroid Injection

Eligibility Criteria

Inclusion Criteria

1. 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;

2. The current episode has occurred within 6 weeks without treatment before eligibility assessment, and the target side has moderate-to-severe symptoms.

Exclusion Criteria

1. Patients who have plan for surgical treatment on his or her CTS within the following 6 months;

2. Any secodary CTS caused by comorbid diseases, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.;

3. History of fracture or surgery on the target side of the wrist;

4. Bilateral CTS with moderate or severe symptoms in both hands;

5. Received corticosteroid injections in the wrist within the past 6 months;

6. Patients who are unable to wear a splint due to trauma or other reasons;

7. 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.;

8. Patients who require long-term use of any form of analgesic medication, such as NSAIDs (nonsteroidal anti-inflammatory drugs), opioids, acetaminophen, etc.;

9. Patients who have used NSAIDs, opioids (e.g., tramadol), neuropathic pain medications (gabapentin, pregabalin, etc.), or oral corticosteroids within the past 2 weeks;

10. 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;

11. Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

Yun Qian

OTHER

Sponsor Role: lead

Responsible Party

Yun Qian

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Jinjiang, Fujian, China

Yancheng Third People's Hospital

Yancheng, Jiangsu, China

Shanghai Sixth People's Hospital

Shanghai, , China

Countries

China

Central Contacts

Jiaqi Su

Role: CONTACT

sjqjswy@foxmail.com

86 21 64369181

Yun Qian

Role: CONTACT

sakio@sjtu.edu.cn

86 21 64369181

Facility Contacts

Yun Qian

Role: primary

sakio@sjtu.edu.cn

86 21 64369181

Other Identifiers

2025-KY-097

Identifier Type: -

Identifier Source: org_study_id