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Musculoskeletal DiseasesNCT05222126

Efficacy of Ultrasound-Guided Hydrodissection in Carpal Tunnel Syndrome

A study testing Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose, Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline and Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose in people with Musculoskeletal Diseases and Median Nerve Disease, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose, Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline and Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Sep 2022to 10 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Rheumatoid arthritis, systemic lupus erythematosus, gout, systemic sclerosis, dermatomyositis, polymyositis
  • Presence of malignancy
  • Presence of active infection

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Afyonkarahisar Health Sciences University

    Afyonkarahisar, Afyonkarahi̇sar, 03200

Other trials in Turkey (Türkiye)

About this study

Official title: Efficacy of Ultrasound-Guided Hydrodissection in Patients With Carpal Tunnel Syndrome

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.

Read the 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.

Being tested
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
Keywords
Carpal Tunnel Syndrome, Ultrasound-Guided Injection, Hydrodissection
Medical subject headings
Musculoskeletal Diseases, Median Neuropathy, Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-guided Hydrodissection (HD) with 5 cc 5% DextroseProcedure or surgery

    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.

  • Ultrasound-guided Hydrodissection (HD) with 5 cc Normal SalineProcedure or surgery

    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.

  • Ultrasound-guided Hydrodissection (HD) with 10 cc 5% DextroseProcedure or surgery

    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.

  • Ultrasound-guided Hydrodissection (HD) with 10 cc Normal SalineProcedure or surgery

    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.

Study groups in NCT05222126
Study groupRoleWhat they receive
Ultrasound-guided Hydrodissection (HD) with 5 cc 5% DextroseExperimentalThe 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.
Receives: Procedure: Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose
Ultrasound-guided Hydrodissection (HD) with 5 cc Normal SalineActive comparatorThe 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.
Receives: Procedure: Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline
Ultrasound-guided Hydrodissection (HD) with 10 cc 5% DextroseExperimentalThe 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.
Receives: Procedure: Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose
Ultrasound-guided Hydrodissection (HD) with 10 cc Normal SalineActive comparatorThe 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.
Receives: Procedure: Ultrasound-guided Hydrodissection (HD) with 10 cc Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 12th week

Secondary outcomes (4)
  1. 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.

    Measured: up to 12th week

  2. 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.

    Measured: up to 12th week

  3. 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).

    Measured: up to 12th week

  4. 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.

    Measured: up to 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2022
  2. Study start20 Sep 2022
  3. Primary completion20 Dec 2023
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05222126
Sponsor's protocol ID
CTSHD22
Status last verified
Jan 2024
First submitted
31 Jan 2022
Last updated
11 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32617017
  • 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.

    PubMed 32162601
  • 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.

    PubMed 32801851
  • Eyvaz N, Adar S, Akcin AI, Dundar U, Toktas H, Eroglu S. Comparison of Ultrasound-Guided Hydrodissection With Various Volumes of 5% Dextrose for Carpal Tunnel Syndrome: A Prospective Randomized Controlled Double-Blind Trial. Am J Phys Med Rehabil. 2025 Jul 1;104(7):596-604. doi: 10.1097/PHM.0000000000002675. Epub 2024 Dec 3.

    PubMed 39642354

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose, Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline and Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose in people with Musculoskeletal Diseases and Median Nerve Disease, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: up to 12th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05222126, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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