Clinical trial NCT05222126: Efficacy of Ultrasound-Guided Hydrodissection in Carpal Tunnel Syndrome
Official title: Efficacy of Ultrasound-Guided Hydrodissection in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Median Nerve Disease
Carpal Tunnel Syndrome
Ultrasound-Guided Injection
Keywords: Carpal Tunnel Syndrome
Ultrasound-Guided Injection
Hydrodissection
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to determine the effectiveness of US-guided hydrodissection of the median nerve in different contents and volumes in patients diagnosed with mild to moderate carpal tunnel syndrome.

Detailed description: Carpal tunnel syndrome is the most common form of entrapment neuropathies. Anatomically, the roof of the carpal tunnel consists of carpal bones, it is located under the transverse carpal ligament, and there are 9 tendon packs of the forearm flexors and the median nerve. Clinically, sensory (paresthesia and hypoesthesia), motor deficits and pain occur in the distribution of the median nerve secondary to mechanical compression and local ischemia.

Conservative treatment options are available for patients diagnosed with mild and moderate CTS as a result of CTS classification. Treatment options for symptom relief include physical therapy applications, splinting, and wrist injections. Among local injection treatments; applications such as corticosteroids and local anesthetics are included.

Ultrasound-guided injections of peripheral nerves are generally superior to blind injections as they prevent damage to critical vascular structures in the surrounding tissue accompanying the nerves and reduce the risk of intraneural injections.

Ultrasound (US) guided hydrodissection of peripheral nerves (HD) is a technique that uses high-resolution ultrasound-guided fluid injection to separate nerves from a surrounding or adjacent structure, usually fascia. The aim is to restore function to the nerve and to release soft tissue adhesions that cause entrapment.

This investigation was designed double-blind prospective randomized study. Participants were randomized into 4 groups: Ultrasound-guided Hydrodissection (HD) with 5 cc 5% dextrose, Ultrasound-guided Hydrodissection (HD) with 5 cc normal saline, Ultrasound-guided Hydrodissection (HD) with 10 cc 5% dextrose, Ultrasound-guided Hydrodissection (HD) with 10 cc normal saline.

Ultrasonographic evaluation and ultrasound-guided injection were planned to be performed with the 10-18-MHz linear probe of the MyLab 70 (Esaote, Genova, Italy) device by a physician experienced in US. It was designed in such a way that the physician was blind to the clinical information of the patients and the injected material.

As evaluation parameters, Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), Cross-sectional Area of Median Nerve (CSA), Hand and finger grip strength assessment, and Electrophysiological assessment will be evaluated. It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the 1st month and at the 3rd month controls.

Eligibility criteria: Inclusion Criteria:

* Presence of symptoms of carpal tunnel syndrome, including nocturnal, postural, or movement-related paresthesias +/- pain in the median nerve distribution area in the hand for more than 3 months
* Presence of mild to moderate carpal tunnel syndrome proven by electrophysiological study
* Loss of sensation with numbness in the median nerve-innervated areas of the hand, weakness of the median nerve-innervated thenar muscles
* Positive Phalen test and/or Tinel sign

Exclusion Criteria:

* Patients who can mimic the diagnosis of carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
* Patients who have had an injection into the carpal tunnel in the last 6 months
* Patients with thenar muscle atrophy
* History of Carpal tunnel surgery
* Regular use of systemic nonsteroidal anti-inflammatory drugs and corticosteroids
* Pregnancy
* Rheumatoid arthritis, systemic lupus erythematosus, gout, systemic sclerosis, dermatomyositis, polymyositis
* Presence of malignancy
* Presence of active infection

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: up to 12th week
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
timeFrame: up to 12th week
measure: Cross-sectional area of the Median Nerve (CSA)
timeFrame: up to 12th week
measure: Electrophysiological Evaluation
timeFrame: up to 12th week
measure: Hand and Finger Grip Strength Assessment
timeFrame: up to 12th week
Other outcomes:
Locations:
city: Afyonkarahi̇sar
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: Babaei-Ghazani A, Forogh B, Raissi GR, Ahadi T, Eftekharsadat B, Yousefi N, Rahimi-Dehgolan S, Moradi K. Ultrasound-Guided Corticosteroid Injection in Carpal Tunnel Syndrome: Comparison Between Radial and Ulnar Approaches. J Pain Res. 2020 Jun 26;13:1569-1578. doi: 10.2147/JPR.S248600. eCollection 2020.
citation: Chang KV, Wu WT, Ozcakar L. Ultrasound imaging and guidance in peripheral nerve entrapment: hydrodissection highlighted. Pain Manag. 2020 Mar;10(2):97-106. doi: 10.2217/pmt-2019-0056. Epub 2020 Mar 12.
citation: Lam KHS, Hung CY, Chiang YP, Onishi K, Su DCJ, Clark TB, Reeves KD. Ultrasound-Guided Nerve Hydrodissection for Pain Management: Rationale, Methods, Current Literature, and Theoretical Mechanisms. J Pain Res. 2020 Aug 4;13:1957-1968. doi: 10.2147/JPR.S247208. eCollection 2020.