The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome

NCT02990962 | Completed DMC

• 1 other identifier: PIT for CTS
• Study Type: interventional
• Target: 54
• 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. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration including steroid injection. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. The investigators design a randomized, double-blind, controlled trail to assess the effect of ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared with steroid injection.

Conditions

Carpal Tunnel Syndrome

Keywords

perineural injection; ultrasound-guided; dextrose; steroid

Outcome Measures

Primary Outcomes (1)

• Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.

  Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

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

Secondary Outcomes (3)

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

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

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

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

• Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.

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

Study Arms (2)

Perineural injection with 5% dextrose

EXPERIMENTAL

Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve.

Drug: 5% dextrose

Perineural injection with steroid

ACTIVE COMPARATOR

Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve.

Drug: 1cc 2% Xylocaine+4cc Triamcinolone (40mg)

Interventions

5% dextrose DRUG

Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.

Perineural injection with 5% dextrose

1cc 2% Xylocaine+4cc Triamcinolone (40mg) DRUG

Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.

Perineural injection with steroid

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 20-85 year-old.
• Diagnosis was confirmed using an electrophysiological study and ultrasonography

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 (5)

• Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.

  PMID: 21623291 RESULT

• Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.

  PMID: 15138901 RESULT

• Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.

  PMID: 15920223 RESULT

• Girlanda P, Dattola R, Venuto C, Mangiapane R, Nicolosi C, Messina C. Local steroid treatment in idiopathic carpal tunnel syndrome: short- and long-term efficacy. J Neurol. 1993;240(3):187-90. doi: 10.1007/BF00857526.

  PMID: 8482993 RESULT

• Armstrong T, Devor W, Borschel L, Contreras R. Intracarpal steroid injection is safe and effective for short-term management of carpal tunnel syndrome. Muscle Nerve. 2004 Jan;29(1):82-8. doi: 10.1002/mus.10512.

  PMID: 14694502 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Glucose

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)

Hexoses; Monosaccharides; Sugars; Carbohydrates

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 physical medicine and rehabilitation

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)