Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome

NCT03802435 | Completed DMC

• 1 other identifier: Different PIT for CTS
• Study Type: interventional
• Target: 30
• 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. The technique of perineural injection therapy (PIT) by using 5% dextrose (D5W) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. However, the evidence and reference of PIT and nerve hydrodissection are very seldom until our series researches since 2017. Moreover, our research revealed PIT with D5W is more beneficial than that of corticosteroid in patients with mild-to-moderate CTS at 4 to 6 months postinjection. However, the accumulative effect and long-term effect (more than 6 months) of PIT is still unknown. Hence, we design a randomized, double- blind, controlled trail to assess the long-term effect of ultrasound-guided PIT in patients with CTS. The aim one is to survey the possible accumulative effect of different sessions of PIT (6 months follow-up) and aim two is to evaluate the long-term effect and safety of PIT (one year follow-up).

Conditions

Carpal Tunnel Syndrome

Keywords

perineural injection therapy; nerve hydrodissection

Outcome Measures

Primary Outcomes (1)

• Change from baseline of severity of symptoms and functional status on 1st, 3rd, 6th, 9th month and one year after injection

  Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

  Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

Secondary Outcomes (3)

• Change from baseline of pain on 1st, 3rd, 6th, 9th month and one year after injection

  Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

• Change from baseline of cross-sectional area of the median nerve on 1st, 3rd, 6th, 9th month and one year after injection

  Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

• Change from baseline of electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection

  Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

Study Arms (3)

Two-sessions of ultrasound-guided PIT

EXPERIMENTAL

two-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)

Procedure: two-sessions of ultrasound-guided PIT

One-session of ultrasound-guided PIT

ACTIVE COMPARATOR

one-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)

Procedure: One-sessions of ultrasound-guided PIT

Two-session of ultrasound-guided nerve hydrodissection

PLACEBO COMPARATOR

two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).

Procedure: Placebo ultrasound-guided injection with nerve hydrodissection

Interventions

two-sessions of ultrasound-guided PIT PROCEDURE

two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)

Two-sessions of ultrasound-guided PIT

One-sessions of ultrasound-guided PIT PROCEDURE

One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)

One-session of ultrasound-guided PIT

Placebo ultrasound-guided injection with nerve hydrodissection PROCEDURE

Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).

Two-session of ultrasound-guided nerve hydrodissection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.

  PMID: 30339737 RESULT

• 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

• Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.

  PMID: 30187524 RESULT

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

• 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: January 9, 2019
• First Posted: January 14, 2019
• Study Start: August 1, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)