search
Back to results

Efficacy of Ultrasound-Guided Hydrodissection in Carpal Tunnel Syndrome

Primary Purpose

Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
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
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases focused on measuring Carpal Tunnel Syndrome, Ultrasound-Guided Injection, Hydrodissection

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Afyonkarahisar Health Sciences UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

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

Arm Description

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve using 5 cc of 5% dextrose.

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve , using 5 cc normal saline.

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve , using 10 cc 5% dextrose.

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve from , using 10 cc normal saline.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

Secondary Outcome Measures

Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a frequently used questionnaire for CTS that includes 2 components. It evaluates for grading under two sub-headings: symptom severity scale (11 questions) and functional status scale (8 questions). Scores range from 0 to 5 for each question; 0 represents no difficulty during the activity, 5 represents extremely severe dysfunction.
Cross-sectional area of the Median Nerve (CSA)
The cross-sectional area (CSA) of the median nerve will be used for analysis by the mean value of 3 measurements made with an electronic caliper at the same level as the injection site (scaphoid-pisiform level). CSA values increase as clinical findings worsen.
Electrophysiological Evaluation
Antidromic sensory nerve conduction velocity and distal motor latency of the median nerve will be measured in all patients. All measurements will be made 3 times and the average value will be taken. To diagnose CTS electrophysiologically; The median nerve peak sensory conduction velocity recorded antidromically from the second finger should be slower than 41.25 m/sec, the conduction velocity should be slower than 34 m/sec in the mixed nerve conduction study in the palm-wrist segment (8 cm), and/or recordings from the APB (abductor pollicis brevis) muscle DML (distal motor latency) was determined to be longer than 3.8 ms with stimulation of the median nerve from the wrist segment (5 cm).
Hand and Finger Grip Strength Assessment
The hand grip strength of the participants will be measured with the "Jamar Hand Dynamometer". Measurements will be made with the shoulder in adduction and neutral rotation adjacent to the trunk, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumb up. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength.

Full Information

First Posted
January 31, 2022
Last Updated
July 27, 2023
Sponsor
Afyonkarahisar Health Sciences University
search

1. Study Identification

Unique Protocol Identification Number
NCT05222126
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
September 25, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome, Ultrasound-Guided Injection
Keywords
Carpal Tunnel Syndrome, Ultrasound-Guided Injection, Hydrodissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose
Arm Type
Experimental
Arm Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve using 5 cc of 5% dextrose.
Arm Title
Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline
Arm Type
Active Comparator
Arm Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve , using 5 cc normal saline.
Arm Title
Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose
Arm Type
Experimental
Arm Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve , using 10 cc 5% dextrose.
Arm Title
Ultrasound-guided Hydrodissection (HD) with 10 cc Normal Saline
Arm Type
Active Comparator
Arm Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve from , using 10 cc normal saline.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose
Intervention Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 5 cc of 5% dextrose.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline
Intervention Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 5 cc normal saline.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose
Intervention Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 10 cc 5% dextrose.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Hydrodissection (HD) with 10 cc Normal Saline
Intervention Description
The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 10 cc normal saline.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Time Frame
up to 12th week
Secondary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Description
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a frequently used questionnaire for CTS that includes 2 components. It evaluates for grading under two sub-headings: symptom severity scale (11 questions) and functional status scale (8 questions). Scores range from 0 to 5 for each question; 0 represents no difficulty during the activity, 5 represents extremely severe dysfunction.
Time Frame
up to 12th week
Title
Cross-sectional area of the Median Nerve (CSA)
Description
The cross-sectional area (CSA) of the median nerve will be used for analysis by the mean value of 3 measurements made with an electronic caliper at the same level as the injection site (scaphoid-pisiform level). CSA values increase as clinical findings worsen.
Time Frame
up to 12th week
Title
Electrophysiological Evaluation
Description
Antidromic sensory nerve conduction velocity and distal motor latency of the median nerve will be measured in all patients. All measurements will be made 3 times and the average value will be taken. To diagnose CTS electrophysiologically; The median nerve peak sensory conduction velocity recorded antidromically from the second finger should be slower than 41.25 m/sec, the conduction velocity should be slower than 34 m/sec in the mixed nerve conduction study in the palm-wrist segment (8 cm), and/or recordings from the APB (abductor pollicis brevis) muscle DML (distal motor latency) was determined to be longer than 3.8 ms with stimulation of the median nerve from the wrist segment (5 cm).
Time Frame
up to 12th week
Title
Hand and Finger Grip Strength Assessment
Description
The hand grip strength of the participants will be measured with the "Jamar Hand Dynamometer". Measurements will be made with the shoulder in adduction and neutral rotation adjacent to the trunk, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumb up. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength.
Time Frame
up to 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Izzet AKÇİN, MD
Phone
+905469347374
Email
dr.akcin93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nuran EYVAZ, MD
Phone
+905334262442
Email
n_eyvaz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuran EYVAZ, MD
Organizational Affiliation
Afyonkarahisar Health Sciences University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali İzzet AKÇİN, MD
Organizational Affiliation
Afyonkarahisar Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Afyonkarahisar Health Sciences University
City
Afyonkarahi̇sar
ZIP/Postal Code
03200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali İzzet AKÇİN, MD
Phone
+905469347374
Email
dr.akcin93@gmail.com
First Name & Middle Initial & Last Name & Degree
Nuran EYVAZ, MD
Phone
+905334262442
Email
n_eyvaz@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32617017
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.
Results Reference
background
PubMed Identifier
32162601
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.
Results Reference
background
PubMed Identifier
32801851
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.
Results Reference
background

Learn more about this trial

Efficacy of Ultrasound-Guided Hydrodissection in Carpal Tunnel Syndrome

We'll reach out to this number within 24 hrs