Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAfyonkarahisar Health Sciences University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimal Incision Surgery for median nerve decompression

    Procedure/Surgery

    Classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.

  • Ultrasound-guided perineural injection with 5 cc 5% Dextrose

    Procedure/Surgery

    The median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Minimal Incision Surgery for median nerve decompressionActive comparator 1 intervention
Group B: Ultrasound-guided perineural injection with 5 cc 5% DextroseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline visual analog scale (VAS) wrist pain at 4th and 12th week

Pain intensity was assessed using a visual analogue scale for pain, ranging from 0 to 10 mm, where 0 indicates the absence of pain and 10 signifies intense pain. This scale is widely recognized for its strong reliability and validity in measuring musculoskeletal pain.

Time frame
baseline and 12th week

Secondary outcomes

1

Change from baseline Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 4th and 12th week

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a commonly used questionnaire for CTS, comprising two main components. It assesses severity using two categories: a symptom severity scale with 11 questions and a functional status scale with 8 questions. Each question is rated on a scale of 0 to 5, where 0 indicates no difficulties during the activity, and 5 indicates extremely severe dysfunction.

Time frame
baseline and 12th week
2

Change from baseline Cross-sectional area of the Median Nerve (CSA) at 4th and 12th week

The median nerve's cross-sectional area (CSA) will be assessed at the scaphoid-pisiform level using an ultrasound. Three measurements will be taken, and the analysis will utilize the average of these three measurements. CSA values increase as clinical findings worsen.

Time frame
baseline and 12th week
3

Change from baseline Electrophysiological Evaluation at 4th and 12th week

Antidromic sensory nerve conduction velocity and distal motor latency of the median nerve will be assessed for all patients. These measurements will be performed three times, and the resulting average value will be considered. CTS will be identified as mild, modarate or severe by electrophysiologic evaluations.

Time frame
baseline and 12th week
4

Change from baseline Hand Grip Strength Assessment at 4th and 12th week

The participants' hand grip strength will be assessed using the "Jamar Hydrolic Hand Dynamometer." . Patients will be instructed to exert maximum force, and each measurement will be repeated three times, with the averages recorded in kilograms. Higher scores indicate better grip strength.

Time frame
baseline and 12th week

Other outcomes

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