The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

NCT ID: NCT03381521

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were inclused and randomized into three groups. Group A, patients received one-session of ultrasoung-guided nerve hydrodissection with 10cc normal saline; Group B, patients received one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline; The injection syringe was covered to obscure the nature of its contents and patients were asked to turn their head away so that they would not see the procedure. As a result, patients were blinded to the treatment condition. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and global assessment of treatment. The evaluations were performed pretreatment as well as on the 2nd week, 1st, 3rd and 6th month after injecton.

Conditions

Carpal Tunnel Syndrome

Study Design

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

Study Groups

Group A

Ultrasound-guided nerve hydrodissection with 10cc normal saline

Group Type: EXPERIMENTAL

Ultrasound-guided nerve hydrodissection

Intervention Type: PROCEDURE

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

Ultrasound

Intervention Type: DEVICE

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

Normal saline

Intervention Type: DRUG

The normal saline was used for injection solution

Group B

Ultrasound-guided nerve hydrodissection with 5cc normal saline

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided nerve hydrodissection

Intervention Type: PROCEDURE

Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.

Ultrasound

Intervention Type: DEVICE

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

Normal saline

Intervention Type: DRUG

The normal saline was used for injection solution

Interventions

Ultrasound-guided nerve hydrodissection

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

Intervention Type: PROCEDURE

Ultrasound-guided nerve hydrodissection

Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.

Intervention Type: PROCEDURE

Ultrasound

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

Intervention Type: DEVICE

Normal saline

The normal saline was used for injection solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yung-Tsan Wu

Attending Physician of Department of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yung-Tsan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Taipei, Neihu District, Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 28778254 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25932413 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28622409 (View on PubMed)

Other Identifiers

Nerve hydrodissection for CTS

Identifier Type: -

Identifier Source: org_study_id