Short Term Efficacy of 5% Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in CTS

NCT ID: NCT06189651

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-12-12

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Wrist splint treatment

The same type of wrist splint was given

Group Type: EXPERIMENTAL

wrist splint

Intervention Type: DEVICE

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. 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.

Wrist splint treatment+ %5 dextrose injection

The same type of wrist splint was given and 5% dextrose injection using USG-guided nerve hydrodissection method was applied

Group Type: EXPERIMENTAL

wrist splint

Intervention Type: DEVICE

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. 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.

5% dextrose injection using USG-guided nerve hydrodissection method

Intervention Type: PROCEDURE

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.

Interventions

wrist splint

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. 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.

Intervention Type: DEVICE

5% dextrose injection using USG-guided nerve hydrodissection method

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nazlı Derya Bugdayci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nazli Derya Bugdayci, Assoc. Prof.

Role: STUDY_DIRECTOR

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Locations

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

STEDIUGNHMCTS

Identifier Type: -

Identifier Source: org_study_id