The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

NCT03381521 | Completed DMC

• 1 other identifier: Nerve hydrodissection for CTS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The technique of nerve hydrodissection is now commonly used for peeling the nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the nerve with ischemic damage. However, the exact effect and interval of hydrodissection are unknown because of the lack of well-designed studies Hence, investigators design a randomized, double- blind, controlled trail to assess the therapeutic effect of ultrasound-guided nerve hydrodissection in patients with CTS.

Conditions

Carpal Tunnel Syndrome

Keywords

nerve hydrodissection

Outcome Measures

Primary Outcomes (1)

• Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd and 6th month after injection

  Using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment. BCTQ includes two subscale (11 questions in symptom severity and 8 questions in functional status). The scores ranged from 0 to 5 points in each question, in which zero score refered to as mildest and no difficulty in activity; five scores mean most worst severity and dysfunction.

  Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection

Secondary Outcomes (3)

• Change from baseline of pain on 2nd week, 1st, 3rd and 6th month after injection

  Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection

• Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd and 6th month after injection

  Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection

• Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd and 6th month after injection

  Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection

Study Arms (2)

Group A

EXPERIMENTAL

Ultrasound-guided nerve hydrodissection with 10cc normal saline

Procedure: Ultrasound-guided nerve hydrodissection; Device: Ultrasound; Drug: Normal saline

Group B

ACTIVE COMPARATOR

Ultrasound-guided nerve hydrodissection with 5cc normal saline

Procedure: Ultrasound-guided nerve hydrodissection; Device: Ultrasound; Drug: Normal saline

Interventions

Ultrasound-guided nerve hydrodissection PROCEDURE

Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.

Group A

Ultrasound DEVICE

The ultrasound was used to measure cross-sectional area and injection guidance

Group A; Group B

Normal saline DRUG

The normal saline was used for injection solution

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-80 year-old.
• Diagnosis was confirmed using an electrophysiological study

You may not qualify if:

• Cancer
• Coagulopathy
• Pregnancy
• Inflammation status
• Cervical radiculopathy
• Polyneuropathy, brachial plexopathy
• Thoracic outlet syndrome
• Previously undergone wrist surgery or steroid injection for CTS

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (3)

• Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.

  PMID: 28778254 RESULT

• Choi CK, Lee HS, Kwon JY, Lee WJ. Clinical implications of real-time visualized ultrasound-guided injection for the treatment of ulnar neuropathy at the elbow: a pilot study. Ann Rehabil Med. 2015 Apr;39(2):176-82. doi: 10.5535/arm.2015.39.2.176. Epub 2015 Apr 24.

  PMID: 25932413 RESULT

• Evers S, Thoreson AR, Smith J, Zhao C, Geske JR, Amadio PC. Ultrasound-guided hydrodissection decreases gliding resistance of the median nerve within the carpal tunnel. Muscle Nerve. 2018 Jan;57(1):25-32. doi: 10.1002/mus.25723. Epub 2017 Jul 6.

  PMID: 28622409 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonography; Saline Solution

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yung-Tsan Wu, MD

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 22, 2017
• Study Start: August 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)