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

NCT ID: NCT02990962

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-04-01

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.

Detailed Description

After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with steroid. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.

Conditions

Carpal Tunnel Syndrome

Study Design

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

Study Groups

Perineural injection with 5% dextrose

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

Group Type: EXPERIMENTAL

5% dextrose

Intervention Type: DRUG

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

Perineural injection with steroid

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

5% dextrose

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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: Yes

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yung-Tsan Wu

Attending physician 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

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.

Reference Type: RESULT

PMID: 21623291 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15138901 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15920223 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8482993 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14694502 (View on PubMed)

Other Identifiers

PIT for CTS

Identifier Type: -

Identifier Source: org_study_id