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

NCT06189651 | Completed

• 1 other identifier: STEDIUGNHMCTS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; hydrodissection; 5% dextrose; wrist splint

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  VAS was used to measure the severity of pain-paresthesia. Patients were given a white paper with a horizontal straight line with numbers from 0 to 10. The patients were told that the left-hand side of the line described gradually decreasing pain and the right-hand side described gradually increasing pain and that a score of 0 corresponded to no pain-paresthesia and a score of 10 corresponded to intolerable pain-paresthesia and were asked to mark a number on the scale.

  Start of the study (week 0) and at the end of the 4th week.

• Boston Carpal Tunnel Questionnaire (BCTQ)

  The BCTQ includes an eleven-question symptom severity scale (BCTQS) and an eight-question functional status scale (BCTQF) that assesses the degree of difficulty in daily activities. Symptom severity ranges from 11 (no symptoms) to 55 (severe symptoms). The functional status scale ranges from 8 (least difficulty) to 40 (maximum difficulty). Turkish version has been tested for reliability and validity.

  Start of the study (week 0) and at the end of the 4th week.

Secondary Outcomes (2)

• Grip Strength (GS)

  Start of the study (week 0) and at the end of the 4th week.

• Median Nerve Cross Sectional Area (CSA)

  Start of the study (week 0) and at the end of the 4th week.

Study Arms (2)

Wrist splint treatment

EXPERIMENTAL

The same type of wrist splint was given

Device: wrist splint

Wrist splint treatment+ %5 dextrose injection

EXPERIMENTAL

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

Device: wrist splint; Procedure: 5% dextrose injection using USG-guided nerve hydrodissection method

Interventions

wrist splint 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; Wrist splint treatment+ %5 dextrose injection

5% dextrose injection using USG-guided nerve hydrodissection method 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.

Wrist splint treatment+ %5 dextrose injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Nazli Derya Bugdayci, Assoc. Prof.

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, clinical trials

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 12, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

TU (1)