search
Back to results

Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHINCORT
XYLOCAINE
sham electroacupuncture
electroacupuncture
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring acupuncture, electrical stimulation, carpal tunnel syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All participants are must above 20 years old,
  2. All participants are willing to join and can be cooperated with all the interviews and examinations.
  3. The symptoms are compatible with carpal tunnel syndrome, including numbness, pain, paresthesia, tingling, burning sensation over a least 2 fingers and hand motor limitation which are dominated by median nerve.These symptoms have to sustain for more than 3 months and be diagnosed by electromyography, physical examination and physicians.
  4. Those who underwent local injection including glucose, steroid or anaphylaxis will be recruited if the treatments finished more than a year.

Exclusion Criteria:

  1. symptoms due to radiculopathy (When the patient also complains of symptoms radiating to the elbow or neck movement pain, the orthopedic doctor will make the definite diagnosis. )
  2. Those who underwent decompression surgery.
  3. CTS due to traumatic injury (confirmed by image)
  4. Those who underwent local injection within a year.
  5. CTS due to rheumatoid arthritis
  6. CTS due to cancer
  7. CTS due to peripheral artery occlusive disease
  8. Those who have past history of psychosis.
  9. Pregnancy(every woman will be confirmed by urine pregnancy test)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Injection of Shincort 0.5 ml and Xylocaine 0.5ml mixture

    sham electroacupuncture

    electroacupuncture

    Arm Description

    In the first week of recruitment, this group will receive the local injection around the distal wrist crease with mixture of Shincort Inj(10mg/ml) 0.5 ml and xylocaine(20mg/ml) 0.5 ml only one time. The ultrasound-guided procedure is performed by the orthopedic physician.

    In this group, the participants receive acupuncture treatment and only 2 minutes electrical stimulation. Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. After 2 minutes, the stimulator will turn off spontaneously and the participant will not be informed. The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times).

    In this group, the participants receive acupuncture treatment and 20 minutes electrical stimulation. Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times).

    Outcomes

    Primary Outcome Measures

    pain assessed on visual analog scale
    Boston Carpal Tunnel Syndrome Questionaire
    The 6-item CTS symptoms scale
    cross sectional area(CSA) of the median nerve
    CSA of the median nerve below the distal wrist crease which is measured by the ultrasound(transverse view )
    hand grip power
    Jamar Hand grip Dynamometer as the measuring tool
    The Disabilities of the Arm, Shoulder and Hand (DASH) Score
    compound muscle action potential(CMAP)
    The CMAP is a summated voltage response from the individual muscle fibre action potentials and measured in millivolts (mV).
    Wrist-palm sensory nerve conduction velocity(Wrist-palm SNCV)
    Wrist-palm SNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency wrist- latency palm(ms)].
    motor nerve conduction velocity(MNCV)
    MNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency site 2 - latency site 1 (ms)].
    sensory nerve action potential(SNAP)
    The sensory nerve action potential (SNAP) is obtained by electrically stimulating sensory fibres and recording the nerve action potential at a point further along that nerve.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2016
    Last Updated
    August 18, 2016
    Sponsor
    Taipei Medical University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02870673
    Brief Title
    Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome
    Official Title
    Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral neuropathy and usually happened to female, mid-age population, overweight persons, and those who overused their hands for work or production. Some research claimed this might be correlated to anatomical characteristics such as the longer anteroposterior diameter or smaller cross section area of the wrist. Preliminary symptoms often start with sensory domain (pain, tingling, paresthesia and especially night awakening due to symptoms mentioned above) and then progress to motor domain (thenar muscle atrophy and clumsiness) if left untreated. Depending on the severity, patient's willingness and convenience, there are many options for CTS. For those whose symptoms are mild to moderate, conservative therapies are usually the first choice, including physiotherapies, local injection and night splints. Local steroid is proven to be effective to relieve the symptoms of CTS shortly up to 3 months. However, the effects will decline gradually and repetitive injections is suggestive. The patients with severe symptoms which comprise thenar muscle atrophy will be advised to receive decompression surgery.the surgery can alleviate the illness with high success rate up to 70%. Unfortunately, there are still patients who will relapse or undergo side effects, for example, finger weakness. In recent years, acupuncture researches focused on CTS intervention have been outgrowing and promising. Whereas, there are still lack of evidence which stands for the therapeutic effects comparing with local steroid injection. This limits the built-up of suspect mechanism of acupuncture intervention for CTS. This is a preliminary, randomized and single-blinded study which started since 2016 and last for a year. The investigators utilize ultrasound to guide the depth of needle penetration which prevents unnecessarily tissues injury such as artery or dry needle injury. This procedure also guarantees the needles lie directly on the upper surface of the median nerve. One group will receive electrical stimulation and another won't. The investigators use electromyography, cross-section area of median nerve, visual analog scale, Boston Carpal Tunnel Syndrome Questionnaire, six-item scale, The disabilities of the arm, shoulder and hand score and Jamar grip dynamometer as outcome measurements. The results gathered from two experimental groups will be compared with the data from the control group whose participants only receiving local steroid injection once in the first week. The participants are all above 18 years old and complain of illness for a least 3 months without any surgery or local injection for a least 1 year. The investigators set up strict exclusive criteria and sample size estimation is 70.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome
    Keywords
    acupuncture, electrical stimulation, carpal tunnel syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Injection of Shincort 0.5 ml and Xylocaine 0.5ml mixture
    Arm Type
    Active Comparator
    Arm Description
    In the first week of recruitment, this group will receive the local injection around the distal wrist crease with mixture of Shincort Inj(10mg/ml) 0.5 ml and xylocaine(20mg/ml) 0.5 ml only one time. The ultrasound-guided procedure is performed by the orthopedic physician.
    Arm Title
    sham electroacupuncture
    Arm Type
    Experimental
    Arm Description
    In this group, the participants receive acupuncture treatment and only 2 minutes electrical stimulation. Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. After 2 minutes, the stimulator will turn off spontaneously and the participant will not be informed. The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times).
    Arm Title
    electroacupuncture
    Arm Type
    Experimental
    Arm Description
    In this group, the participants receive acupuncture treatment and 20 minutes electrical stimulation. Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times).
    Intervention Type
    Drug
    Intervention Name(s)
    SHINCORT
    Other Intervention Name(s)
    triamcinolone Acetonide
    Intervention Description
    triamcinolone Acetonide (10mg/ml) 0.5 ml
    Intervention Type
    Drug
    Intervention Name(s)
    XYLOCAINE
    Other Intervention Name(s)
    XYLOCAINE IV INJECTION
    Intervention Description
    xylocaine(20mg/ml) 0.5 ml
    Intervention Type
    Device
    Intervention Name(s)
    sham electroacupuncture
    Intervention Description
    1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))
    Intervention Type
    Device
    Intervention Name(s)
    electroacupuncture
    Intervention Description
    1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))
    Primary Outcome Measure Information:
    Title
    pain assessed on visual analog scale
    Time Frame
    24 weeks
    Title
    Boston Carpal Tunnel Syndrome Questionaire
    Time Frame
    24 weeks
    Title
    The 6-item CTS symptoms scale
    Time Frame
    24 weeks
    Title
    cross sectional area(CSA) of the median nerve
    Description
    CSA of the median nerve below the distal wrist crease which is measured by the ultrasound(transverse view )
    Time Frame
    24 weeks
    Title
    hand grip power
    Description
    Jamar Hand grip Dynamometer as the measuring tool
    Time Frame
    24 weeks
    Title
    The Disabilities of the Arm, Shoulder and Hand (DASH) Score
    Time Frame
    24 weeks
    Title
    compound muscle action potential(CMAP)
    Description
    The CMAP is a summated voltage response from the individual muscle fibre action potentials and measured in millivolts (mV).
    Time Frame
    24 weeks
    Title
    Wrist-palm sensory nerve conduction velocity(Wrist-palm SNCV)
    Description
    Wrist-palm SNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency wrist- latency palm(ms)].
    Time Frame
    24 weeks
    Title
    motor nerve conduction velocity(MNCV)
    Description
    MNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency site 2 - latency site 1 (ms)].
    Time Frame
    24 weeks
    Title
    sensory nerve action potential(SNAP)
    Description
    The sensory nerve action potential (SNAP) is obtained by electrically stimulating sensory fibres and recording the nerve action potential at a point further along that nerve.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All participants are must above 20 years old, All participants are willing to join and can be cooperated with all the interviews and examinations. The symptoms are compatible with carpal tunnel syndrome, including numbness, pain, paresthesia, tingling, burning sensation over a least 2 fingers and hand motor limitation which are dominated by median nerve.These symptoms have to sustain for more than 3 months and be diagnosed by electromyography, physical examination and physicians. Those who underwent local injection including glucose, steroid or anaphylaxis will be recruited if the treatments finished more than a year. Exclusion Criteria: symptoms due to radiculopathy (When the patient also complains of symptoms radiating to the elbow or neck movement pain, the orthopedic doctor will make the definite diagnosis. ) Those who underwent decompression surgery. CTS due to traumatic injury (confirmed by image) Those who underwent local injection within a year. CTS due to rheumatoid arthritis CTS due to cancer CTS due to peripheral artery occlusive disease Those who have past history of psychosis. Pregnancy(every woman will be confirmed by urine pregnancy test)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    You-Jen Tang, MD
    Phone
    +886932182791
    Email
    9502060@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome

    We'll reach out to this number within 24 hrs