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Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome(CTS)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
betamethasone
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome(CTS) focused on measuring carpal tunnel syndrome, local steroid injection, sonography, sonography-guided

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • with >2 following symptoms :

    1. disrupt sleep result in nocturnal paresthesia.
    2. symptoms release by shaking hand.
    3. pain and paresthesia during grasping.
    4. any sensory symptom on first, 2th, 3th and partial 4th fingers.
  • symptoms >1month.
  • Padua's classification : minimal, mild, moderate)
  • meet one of three diagnosis criteria of carpal tunnel syndrome.

Exclusion Criteria:

  • any history can cause periphery nerve disease.
  • affected side had fracture or paralysis.
  • had accepted operation for carpal tunnel syndrome before.
  • pregnant
  • wrist or hand sprain, ulnar nerve disease cervical nerve root disease, multiple neuropathy or nerve anastomosis.
  • Padua's classification: severe, extreme.
  • ultrasonography show space occupying.
  • patient taking anticoagulants.
  • severe systemic disease.
  • wrist's skin or wrist joint has infection.
  • can't complete the 6 months' follow up.
  • allergy to steroid.
  • has cognition disorder.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Inject betamethasone by sonography

    Inject betamethasone directly

    Arm Description

    Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease by sonography- guided. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.

    Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease directly. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.

    Outcomes

    Primary Outcome Measures

    QuickDASH

    Secondary Outcome Measures

    Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS
    Record the neurological symptoms perceived by patient after injection according to their describtion
    Semmes-Weinstein Monofilament test(SWMT)
    2-Point Discrimination test on 2nd digit
    Nerve conduction study done on the affected hand using Necolet Viking Quest
    We will record the latency, amplitude and conduction velocity retrieved from nerve conduction study of both motor neurons and sensory neuron
    Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table
    The test will done twice and will record the average data of both the cross-section area and the bowing distance of transverse ligament of wrist.

    Full Information

    First Posted
    September 17, 2015
    Last Updated
    October 12, 2015
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02575729
    Brief Title
    Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
    Official Title
    Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).
    Detailed Description
    Material and methods: We have enrolled 26 ideopathic carpal tunnel syndrome patients (minimal to moderate according to Padua's classification).Thirteen patients were allocated in sonography approach group( sonography-guided local wrist injection, SAG) and the 13 patients were placed in direct approach group(direct local injection without using sonography, DAG). One , 3 and 6 months later after injection, we performed the outcome measures, including Boston symptom and functional scale, QuickDASH, nerve conduction study and sonography. If the patients receive the second injections, we will follow their treatment outcome by phone regularly at 1,3 and 6 months after first injection. If the patients were referred to surgery, the failures of local injection were considered and we will stop follow up them. After performing all assessment, we will compare the outcomes between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome(CTS)
    Keywords
    carpal tunnel syndrome, local steroid injection, sonography, sonography-guided

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inject betamethasone by sonography
    Arm Type
    Experimental
    Arm Description
    Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease by sonography- guided. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.
    Arm Title
    Inject betamethasone directly
    Arm Type
    Active Comparator
    Arm Description
    Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease directly. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.
    Intervention Type
    Drug
    Intervention Name(s)
    betamethasone
    Other Intervention Name(s)
    glucocorticoid preparation
    Intervention Description
    Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.
    Primary Outcome Measure Information:
    Title
    QuickDASH
    Time Frame
    Change from Baseline data at 6 weeks
    Secondary Outcome Measure Information:
    Title
    Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS
    Time Frame
    Change from Baseline data at 6 weeks
    Title
    Record the neurological symptoms perceived by patient after injection according to their describtion
    Time Frame
    Change from Baseline data at 6 weeks
    Title
    Semmes-Weinstein Monofilament test(SWMT)
    Time Frame
    Change from Baseline data at 6 weeks
    Title
    2-Point Discrimination test on 2nd digit
    Time Frame
    Change from Baseline data at 6 weeks
    Title
    Nerve conduction study done on the affected hand using Necolet Viking Quest
    Description
    We will record the latency, amplitude and conduction velocity retrieved from nerve conduction study of both motor neurons and sensory neuron
    Time Frame
    Change from Baseline data at 6 weeks
    Title
    Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table
    Description
    The test will done twice and will record the average data of both the cross-section area and the bowing distance of transverse ligament of wrist.
    Time Frame
    Change from Baseline data at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: with >2 following symptoms : disrupt sleep result in nocturnal paresthesia. symptoms release by shaking hand. pain and paresthesia during grasping. any sensory symptom on first, 2th, 3th and partial 4th fingers. symptoms >1month. Padua's classification : minimal, mild, moderate) meet one of three diagnosis criteria of carpal tunnel syndrome. Exclusion Criteria: any history can cause periphery nerve disease. affected side had fracture or paralysis. had accepted operation for carpal tunnel syndrome before. pregnant wrist or hand sprain, ulnar nerve disease cervical nerve root disease, multiple neuropathy or nerve anastomosis. Padua's classification: severe, extreme. ultrasonography show space occupying. patient taking anticoagulants. severe systemic disease. wrist's skin or wrist joint has infection. can't complete the 6 months' follow up. allergy to steroid. has cognition disorder.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pong Ya-Ping, MD
    Organizational Affiliation
    Rehabilitation
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

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