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

NCT07042282 | Not Yet Recruiting

• 1 other identifier: 2025-KY-096
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Change from baseline in BCTQ function status subscale at 6 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 weeks follow-up.

  0,6 weeks

• Change from baseline in BCTQ symptom severity subscale at 6 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 weeks follow-up.

  0,6 weeks

Secondary Outcomes (6)

• Change from baseline in BCTQ symptom severity subscale

  0,12,18 weeks

• Change from baseline in BCTQ function status subscale

  0,12,18 weeks

• Change from baseline of EQ-VAS

  0,6,12,18 weeks

• Change from baseline of PSQI

  0,6,12,18 weeks

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

  0,18 weeks

Study Arms (2)

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

Interventions

Nighttime Splinting DEVICE

Nighttime splinting for 6 weeks.

Also known as: Wrist Splint

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

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. Throughout the study period, physicians will perform electrophysiological examinations according to changes in patients' clinical status.

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 unilateral or bilateral carpal tunnel syndrome diagnosed by a specialist according to the Katz diagnostic criteria, and with at least one associated rheumatic disease;
• 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.
• During the current episode, the target side has not been treated.

You may not qualify if:

• Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
• 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 opioids.
• Patients who have used opioids (e.g., tramadol) or neuropathic pain medications (gabapentin, pregabalin, etc.) 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;
• Patients who are pregnant or plan to become pregnant within the next 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, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Rheumatic Diseases

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; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

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 25, 2025
• First Posted: June 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)