Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting

NCT ID: NCT07042282

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-08-01

Brief Summary

The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Participants will be randomly assigned to two groups and will receive the following interventions: one group will wear a neutral position night splint for 6 weeks, and the other group will receive a single local injection of methylprednisolone 40 mg as the initial treatment. Follow-up evaluations will be conducted at 6, 12, and 18 weeks to assess wrist function, sleep quality, and quality of life, and to dynamically adjust the treatment plan.

Conditions

Carpal Tunnel Syndrome (CTS); Rheumatic Diseases

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. 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. 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. 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 unilateral or bilateral carpal tunnel syndrome diagnosed by a specialist according to the Katz diagnostic criteria, and with at least one associated rheumatic disease;

2. Patients have had symptoms of CTS for at least six weeks, and the side with more severe symptoms is designated as the target side for the study.

3. During the current episode, the target side has not been treated.

Exclusion Criteria

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

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

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

4. 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.;

5. Patients who require long-term use of any form of opioids.

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

7. 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;

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

9. Patients who are pregnant or plan to become pregnant within the next 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, Shanghai Municipality, 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-096

Identifier Type: -

Identifier Source: org_study_id