Ultrasound-Guided Injection vs Intramuscular Steroid for Carpal Tunnel Syndrome

NCT06725420 | Completed

• 1 other identifier: KonyaBeyhekimTRH2023/1075
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal tunnel syndrome (CTS) is the most common and disability-causing entrapment neuropathy; however, a standardized protocol for first-line management has yet to be established. Different treatment approaches have their own positive and negative aspects. The aim of this study is to compare the effectiveness of ultrasound-guided local steroid injection and intramuscular steroid injection in mild-to-moderate CTS. Patients will be assessed for pain levels, functional/symptom status, hand-finger strength, side effects, patient satisfaction, median nerve ultrasonographic measurements, and EMG before and after treatment .

Conditions

Carpal Tunnel Syndrome (CTS); Chronic Pain

Keywords

Carpal tunnel syndrome; pain; Injection approach; Rehabilitation; Ultrasound-guided; Splints

Outcome Measures

Primary Outcomes (3)

• VAS pain

  VAS pain day and night: 0 no pain; 10 unbearable/max. pain.

  baseline, week 2 and week 6

• The Boston Carpal Tunnel Syndrome Questionnaire

  The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.

  baseline, week 2 and week 6

• Undesirable effects

  Possible side effects such as nerve/vessel injury, bleeding, skin discoloration, fat atrophy, infection, allergy, steroid exacerbation (transient pain starting 24 hours after the injection and lasting a few days), hypertension, and steroid-induced edema will be questioned and recorded in the patients

  Immediately, week 2 and week 6

Secondary Outcomes (10)

• Hand grip strength

  baseline, week 2 and week 6

• Finger pinch strength

  baseline, week 2 and week 6

• Ultrasonographic evaluation of the median nerve

  baseline, week 2 and week 6

• Ultrasonographic evaluation of the median nerve

  baseline, week 2 and week 6

• Sleep quality

  Baseline, week 2 and week 6

Study Arms (3)

local steroid injection

EXPERIMENTAL

The group of patients who were injected with ultrasound-guided in-plane steroid and local anesthetic injection + wrist splint

Other: Ultrasound-guided local Injection; Device: Splinting

intramuscular steroid injection

EXPERIMENTAL

The group of patients who received an intramuscular (gluteal) steroid and local anesthetic injection + wrist plint

Other: Intramuscular Steroid Injection; Device: Splinting

Wrist splint

EXPERIMENTAL

The group of patients who received only a nighttime wrist splint

Device: Splinting

Interventions

Ultrasound-guided local Injection OTHER

Ultrasound-Guided steroid injection and splinting in patients with carpal tunnel syndrome

Also known as: wrist splint

local steroid injection

Intramuscular Steroid Injection OTHER

Intramuscular gluteal steroid injection and Splinting in Patients With Carpal Tunnel Syndrome

Also known as: wrist splint

intramuscular steroid injection

Splinting DEVICE

wrist night splint

Wrist splint; intramuscular steroid injection; local steroid injection

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Presence of typical CTS symptoms (numbness, tingling, paresthesias, or pain that may be provoked by nighttime or activity-related posture
• VAS score of ≥ 3/10
• Symptom duration longer than 12 weeks
• Positive Tinel's and/or Phalen's sign
• Electrophysiologically mild or moderate CTS being diagnosed.
• Volunteer to participate in study

You may not qualify if:

• Patients with shoulder, elbow, wrist, or finger problems (e.g., impingement syndrome, epicondylitis, history of fractures in the wrist, de Quervain's tenosynovitis, trigger finger, Complex Regional Pain Syndrome (CRPS), Dupuytren's contracture).
• Patients with a history of trauma or surgery in the affected hand, or those with significant anatomical deformities.
• Patients with systemic diseases such as rheumatological disorders, hypothyroidism, amyloidosis, diabetes, gout, or chronic kidney failure.
• Patients with conditions that may mimic CTS, such as polyneuropathy, plexopathy, cervical radiculopathy, or thoracic outlet syndrome.
• Patients with cognitive dysfunction or communication issues.
• Patients with severe CTS, neurological deficits (e.g., thenar atrophy, muscle weakness in thumb abduction/opposition), or those requiring surgical intervention.
• Patients who have received local steroid injections or physical therapy to the hand/wrist within the last 6 months.
• Patients who are receiving or will receive another/additional treatment for CTS.
• Pregnant or lactating women.
• Patients with active malignancies or local/systemic infections.
• Patients who are receiving any active treatment (e.g., NSAIDs, oral/intramuscular steroids, acupuncture, other pain medications).
• Patients with upper extremity involvement due to first motor neuron damage (e.g., stroke-hemiplegia, tetraparesis, multiple sclerosis).
• Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.
• Use of a wrist splint during the last 6 months.
• Allergy to corticosteroids or local anesthetics, and blood diathesis

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Chronic Pain; Pain

Interventions

Splints

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (MD)

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 10, 2024
• Study Start: December 10, 2024
• Primary Completion: September 19, 2025
• Study Completion: October 24, 2025
• Last Updated: March 19, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)