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Trial record 78 of 337 for:    Charcot Marie Tooth

Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03802435
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : September 11, 2019
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. 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).

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: two-sessions of ultrasound-guided PIT Procedure: One-sessions of ultrasound-guided PIT Procedure: Placebo ultrasound-guided injection with nerve hydrodissection Not Applicable

Detailed Description:
After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were includes and randomized into three groups. Group A, patients received two-sessions of ultrasound-guided PIT with 5cc D5W (3 months interval); Group B, patients received one-session of ultrasound-guided PIT with 5cc D5W and 5cc normal saline separately (3 months interval); Group C (control group), patients received two-sessions of ultrasound-guided PIT with nerve hydrodissection with 5cc normal saline. 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, nerve conduction velocity of the median nerve, and Global assessment of treatment. The evaluations were performed pretreatment as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Long-term Effect in Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Experimental: Two-sessions of ultrasound-guided PIT
two-sessions of ultrasound-guided PIT with 5cc 5% dextrose (3 months interval)
Procedure: two-sessions of ultrasound-guided PIT
two-sessions of ultrasound-guided PIT with 5cc D5W (3 months interval)

Active Comparator: One-session of ultrasound-guided PIT
one-session of ultrasound-guided PIT with 5cc 5% dextrose and 5cc normal saline separately (3 months interval)
Procedure: One-sessions of ultrasound-guided PIT
One-session of ultrasound-guided PIT with 5cc D5W and 5cc normal saline separately (3 months interval)

Placebo Comparator: Two-session of ultrasound-guided nerve hydrodissection
two-sessions of ultrasound-guided PIT with nerve hydrodissection with 5cc normal saline (3 months interval).
Procedure: Placebo ultrasound-guided injection with nerve hydrodissection
Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 5cc normal saline (3 months interval).




Primary Outcome Measures :
  1. Change from baseline of severity of symptoms and functional status on 1st, 3rd, 6th, 9th month and one year after injection [ Time Frame: Pre-treatment, 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.


Secondary Outcome Measures :
  1. Change from baseline of pain on 1st, 3rd, 6th, 9th month and one year after injection [ Time Frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection ]
    Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

  2. Change from baseline of cross-sectional area of the median nerve on 1st, 3rd, 6th, 9th month and one year after injection [ Time Frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection ]
    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.

  3. Change from baseline of electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection [ Time Frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection ]
    Antidromic sensory nerve conduction velocity of the median 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 20-80 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

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): NCT03802435


Contacts
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Contact: Yung-Tsan Wu, MD +886287923311 ext 17068 crwu98@gmail.com

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Recruiting
Taipei, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    287923311 ext 17068    crwu98@gmail.com   
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 Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03802435     History of Changes
Other Study ID Numbers: Different PIT for CTS
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
perineural injection therapy
nerve hydrodissection
Additional relevant MeSH terms:
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Nerve Compression Syndromes
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