Clinical trial NCT06189651: Short Term Efficacy of 5% Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in CTS
Official title: Short-Term Efficacy of 5% Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in Carpal Tunnel Syndrome: Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
hydrodissection
5% dextrose
wrist splint
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, clinical trials
Primary purpose: TREATMENT

Brief summary: Hydrodissection injection method; It is a safe and effective injection method in peripheral nerve compression that aims to release the adhesions by separating the nerve from the surrounding connective tissues through the liquid given by injection. Perineural injection of 5% dextrose is analgesic in neuropathic pain, although the mechanism is not fully defined. USG-guided 5% dextrose injection using nerve hydrodissection method is promising in the treatment of CTS. In our study, we aimed to investigate the short-term (4 weeks) efficacy of 5% dextrose injection using USG-guided nerve hydrodissection method in combination with wrist splint treatment in patients with mild to moderate carpal tunnel syndrome (CTS) and whether this treatment can provide additional benefit to wrist splint treatment.

Detailed description: In our prospective randomized controlled study, 44 patients who met the inclusion criteria and had mild to moderate carpal measured syndrome with EMG as described in previous studies were included in the study. The 44 volunteer participants with mild to moderate carpal tunnel syndrome were randomly divided into 2 groups as wrist splint treatment group (control group) and wrist splint + 5% dextrose injection treatment group (study group) by stratified and block randomization method. Stratified randomization was done according to the variable of having mild and moderate carpal tunnel syndrome. Assignment to the treatment or control group for each stratum was done by 1:1 block randomization.

All patients were given the same type of wrist splint to be used for at least 8 hours at night for 4 weeks, to be worn in a neutral position and in accordance with the wrist as described in previous studies to restrict movement in the wrist, and activities that aggravate symptoms (repetitive and demanding wrist movements: Knitting, keyboard use, use of vibrating tools, etc.) were recommended to be avoided. The given wrist splint is a commercially available wrist splint with a metal bar on the palmar side and Velcro straps on the dorsal side that can be adjusted according to the wrist, restricting flexion and extension of the wrist and allowing movement of the metacarpophalangeal joint. Patients who did not sleep for 8 hours were asked to complete 8 hours of wrist splint use before going to sleep or after waking up. All patients were given a wrist splint diary and asked to write down the days and hours of splinting. Patients who did not wear splints for enough days and hours were excluded from the study. In the study group, 2 ml each of 5% dextrose injection was administered once at the proximal wrist level above the median nerve separating the median nerve from the flexor retinaculum and below the median nerve separating the median nerve from the flexor tendons by nerve hydrodissection method in the transverse inplane plane under ultrasound guidance. After the application, the spread of the injectate was observed by looking longitudinally at the median nerve. A 25 gauge syringe was used for administration. Patients were observed for side effects and side effects were noted. Patients were asked to rate their injection pain on a Visual Analog Scale (VAS) after injection to measure the pain during injection. All patients were advised not to take any additional treatment for their symptoms during the study. Patients who received additional treatment were noted. All patients were evaluated with Visual Analog Scale (VAS) score, Turkish version of Boston Carpal Tunnel Questionnaire (BCTQ), grip strength (GS) measured by hand dynamometer, and median nerve cross-sectional area (CSA) measured by ultrasonography before the start of the study (week 0) and at the end of the 4th week.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical symptoms for at least 3 months
* Patients with paresthesia or dysesthesia in the fingers
* Patients diagnosed with mild or moderate carpal tunnel syndrome by EMG

Exclusion Criteria:

* Patients with severe carpal tunnel syndrome
* Patients with polyneuropathy, cervical radiculopathy, brachial plexopathy and thoracic outlet syndrome
* Patients with a history of wrist surgery
* Patients within 6 months of steroid injection for carpal tunnel syndrome
* Patients with infection at the treatment site
* Patients with coagulation disorders or on coumadin
* Pregnant patients
* Patients with a history of malignancy, rheumatologic disease
* Patients with any other painful pathology in the upper extremity

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Start of the study (week 0) and at the end of the 4th week.
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: Start of the study (week 0) and at the end of the 4th week.
Secondary outcomes:
measure: Grip Strength (GS)
timeFrame: Start of the study (week 0) and at the end of the 4th week.
measure: Median Nerve Cross Sectional Area (CSA)
timeFrame: Start of the study (week 0) and at the end of the 4th week.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Nazli Derya Bugdayci, Assoc. Prof.
role: STUDY_DIRECTOR
References: