Clinical trial NCT06243848: Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel Syndrome
Official title: Comparison of Ultrasound-Guided Injection With Traditional Median Nerve Decompression Surgery in Patients With Carpal Tunnel Syndrome: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Diseases
Median Nerve Disease
Carpal Tunnel Syndrome
Ultrasound-Guided Injection
Surgery
Keywords: Carpal Tunnel Syndrome
Ultrasound-Guided Injection
Median Nerve Decompression
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.

Detailed description: Carpal tunnel syndrome represents the most prevalent type of entrapment neuropathy. Anatomically, the carpal tunnel is formed by the carpal bones and lies beneath the transverse carpal ligament, housing nine tendon sheaths of the forearm flexors along with the median nerve. From a clinical perspective, individuals with carpal tunnel syndrome typically experience sensory symptoms such as paresthesia and hypoesthesia, as well as motor impairments and pain within the region supplied by the median nerve, all resulting from mechanical compression and localized ischemia.

In the classification of CTS, participants are diagnosed with mild, moderate, or severe CTS, and various treatment options are available for each category. Treatment options aimed at alleviating symptoms include physical therapy, splinting, wrist injections, and surgical procedures Ultrasound-guided injections of peripheral nerves are typically more advantageous than blind injections because minimize the risk of damaging crucial vascular structures in the adjacent tissue alongside the nerves and decrease the likelihood of intraneural injections.

CTS can also be treated surgically, although the literature has not provided sufficient evidence to establish the superiority of one surgical technique over another. However, these procedures are known to be effective by reducing the volume of the carpal tunnel, thereby relieving pressure on the median nerve. In CTS surgery, following a mini-incision, the dissection proceeds through fat and fascial tissue until the flexor retinaculum is reached, ensuring decompression of the median nerve. The advantages of the mini-incision technique include the preservation of neurovascular structures, a low risk of complications, and a high level of patient satisfaction, making it a prominent surgical approach.

The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with the classic minimal incision surgical technique for median nerve decompression in participants diagnosed with mild, moderate, and severe carpal tunnel syndrome.

Eligibility criteria: Inclusion Criteria:

* The presence of symptoms such as nocturnal, posture-related, or movement-related paresthesias, along with possible pain, in the area supplied by the median nerve in the hand, lasting for more than 3 months.
* Confirmation of mild, moderate or severe CTS through electrophysiological testing.
* Numbness and loss of sensation in the hand's regions innervated by the median nerve, as well as weakness in the thenar muscles innervated by the median nerve.
* Positive results on either the Phalen test and/or Tinel sign.

Exclusion Criteria:

* Individuals who may exhibit symptoms mimicking carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
* Patients who have received a previous injection into the carpal tunnel within the past 6 months.
* Thenar muscle atrophy.
* A history of prior carpal tunnel surgery.
* Regular usage of systemic nonsteroidal anti-inflammatory drugs and corticosteroids.
* Pregnancy
* Patients diagnosed with rheumatoid arthritis, systemic lupus erythematosus, gout, systemic sclerosis, dermatomyositis, or polymyositis.
* Malignancy.
* Active infections

Primary outcomes:
measure: Change from baseline visual analog scale (VAS) wrist pain at 4th and 12th week
timeFrame: baseline and 12th week
Secondary outcomes:
measure: Change from baseline Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 4th and 12th week
timeFrame: baseline and 12th week
measure: Change from baseline Cross-sectional area of the Median Nerve (CSA) at 4th and 12th week
timeFrame: baseline and 12th week
measure: Change from baseline Electrophysiological Evaluation at 4th and 12th week
timeFrame: baseline and 12th week
measure: Change from baseline Hand Grip Strength Assessment at 4th and 12th week
timeFrame: baseline and 12th week
measure: Change from baseline Finger Grip Strength Assessment at 4th and 12th week
timeFrame: baseline and 12th week
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Ali İzzet AKÇİN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.
citation: Lin MT, Liu IC, Syu WT, Kuo PL, Wu CH. Effect of Perineural Injection with Different Dextrose Volumes on Median Nerve Size, Elasticity and Mobility in Hands with Carpal Tunnel Syndrome. Diagnostics (Basel). 2021 May 9;11(5):849. doi: 10.3390/diagnostics11050849.
citation: Pace V, Marzano F, Placella G. Update on surgical procedures for carpal tunnel syndrome: What is the current evidence and practice? What are the future research directions? World J Orthop. 2023 Jan 18;14(1):6-12. doi: 10.5312/wjo.v14.i1.6. eCollection 2023 Jan 18.