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Trial record 9 of 22 for:    "Nerve Compression Syndrome" | "Hormones"

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

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ClinicalTrials.gov Identifier: NCT02990962
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: 5% dextrose Drug: 1cc 2% Xylocaine+4cc Triamcinolone (40mg) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Long-term Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
Actual Study Start Date : December 2016
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018


Arm Intervention/treatment
Experimental: Perineural injection with 5% dextrose
Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve.
Drug: 5% dextrose
Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.

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




Primary Outcome Measures :
  1. Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment. [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection ]
    Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.


Secondary Outcome Measures :
  1. Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment. [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection ]
    Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment

  2. Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment. [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection ]
    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.

  3. Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment. [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection ]
    Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990962


Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 886
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
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Responsible Party: Yung-Tsan Wu, Attending physician of physical medicine and rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02990962     History of Changes
Other Study ID Numbers: PIT for CTS
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
perineural injection
ultrasound-guided
dextrose
steroid
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants