<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036657</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008949</org_study_id>
    <nct_id>NCT03036657</nct_id>
  </id_info>
  <brief_title>Local Effects of Acupuncture and Nerve Conduction Studies</brief_title>
  <official_title>Local Effects of Acupuncture on the Median and Ulnar Nerves in Patients With Carpal Tunnel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thus study aims to characterize the local, nerve-specific effects of acupuncture on the&#xD;
      median and ulnar nerves in the forearm, using nerve conduction studies and quantitative&#xD;
      sensory testing. All participant will have carpal tunnel syndrome and the affected median&#xD;
      nerve will be compared to the healthy ulnar nerve. Additionally, we aim to compare the local,&#xD;
      nerve-specific effect of manual acupuncture to that of low-frequency electroacupuncture and&#xD;
      of high-frequency electroacupuncture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to measure the local effects of acupuncture on the median and&#xD;
      ulnar nerves in patients with median neuropathy at the wrist (carpal tunnel syndrome), using&#xD;
      nerve conduction studies (NCS) and quantitative sensory testing (QST) as outcomes. Our&#xD;
      secondary aim is to compare acupuncture's effect on the functioning of a diseased nerve&#xD;
      (median nerve in CTS) to its effect on a healthy nerve (ulnar). Additionally, we aim to&#xD;
      compare the local, nerve-specific effect of manual acupuncture to that of low-frequency&#xD;
      electroacupuncture and of high-frequency electroacupuncture.&#xD;
&#xD;
      In a mechanistic study of acupuncture, 60 subjects with carpal tunnel syndrome (CTS) will be&#xD;
      randomized to manual acupuncture (MA), low-frequency electroacupuncture (LF-EA) and&#xD;
      high-frequency electroacupuncture (HF-EA) groups. Baseline measurements will consist of QST&#xD;
      (vibration and cold detection thresholds), as well as NCS of both median and ulnar nerves.&#xD;
      Then, each group will undergo acupuncture to the median nerve (Pericardium channel points)&#xD;
      and to the ulnar nerve (Heart channel points), one week apart, order counterbalanced,&#xD;
      followed by post-acupuncture NCS and QST measurements in both nerves' territories.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">May 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cold Detection Threshold (CDT) post-acupuncture compared to pre-acupuncture</measure>
    <time_frame>Week 1, Week 2</time_frame>
    <description>Cold Detection Threshold (CDT) will be assessed using the Computer-Aided Sensory Evaluator IV (CASE IV) System (WR MEDICAL ELECTRONICS CO. Maplewood, MN, USA).&#xD;
The CASE IV Thermal Stimulator uses a four-degree-per-second ramp up and down, and is typically operated in a range from 8 degrees to 50 degrees C., with an accuracy of 1.25 to 0.25 degrees C., depending on temperature. For high-magnitude thermal (cooling) stimuli, the absolute temperature is limited to 8 degrees C. Thermal stimuli are approximately 6 seconds in duration. CDT will be assessed over the thenar eminence and hypothenar eminence with the hand on an even surface, supinated and palm facing up.&#xD;
The CDT will be determined using the 4, 2 and 1 stimulus presentation algorithm, developed by Dyck et al (Dyck PJ, O'Brien PC, Kosanke JL, Gillen DA, Karnes JL. A 4, 2, and 1 stepping algorithm for quick and accurate estimation of cutaneous sensation threshold. Neurology. 1993 Aug;43(8):1508-12.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vibration Detection Threshold (VDT) post-acupuncture compared to pre-acupuncture</measure>
    <time_frame>Week 1, Week 2</time_frame>
    <description>VDT will be assessed using the Computer-Aided Sensory Evaluator IV (CASE IV) System (WR MEDICAL ELECTRONICS CO. Maplewood, MN, USA).&#xD;
Vibration Stimuli will be delivered as 25 discrete levels ranging from 0.0 to 350 micrometers (μm) of displacement, based on previously established &quot;Just Noticeable Difference&quot; (JND) values. Each stimulus is presented with an exponential onset, and turns off with an exponential decay, in order to eliminate the touch-pressure artifact, which is caused by an instantaneous on/off. Stimulation will be delivered to the lateral aspect of the 2nd digit nailbed and the lateral aspect of the 5th digit nailbed, with the hand on an even surface, pronated and palm down.&#xD;
The VDT will be determined using the 4, 2 and 1 stimulus presentation algorithm. Dyck PJ, O'Brien PC, Kosanke JL, Gillen DA, Karnes JL. A 4, 2, and 1 stepping algorithm for quick and accurate estimation of cutaneous sensation threshold. Neurology. 1993 Aug;43(8):1508-12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Median and Ulnar nerve CMAP amplitude post-acupuncture compared to pre-acupuncture.</measure>
    <time_frame>Week 1, Week 2</time_frame>
    <description>Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.&#xD;
The Median and Ulnar nerve Compound Muscle Action Potential (CMAP) amplitude will be measured in millivolts (mV) as follows:&#xD;
Median Nerve Conduction Study:&#xD;
We will measure the CMAP amplitude from the Abductor Pollicis Brevis.&#xD;
Ulnar Nerve Conduction Study:&#xD;
We will measure the CMAP amplitude from the Abductor Digiti Minimi.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Median and Ulnar SNAP amplitude post-acupuncture compared to pre-acupuncture</measure>
    <time_frame>Week 1, Week 2</time_frame>
    <description>Pre- and Post-acupuncture nerve conduction studies (NCS) will be performed according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32 C, using a heating pad to warm up a cold hand if needed. The Median and Ulnar nerve sensory nerve action potential (SNAP) amplitude will be measured in microvolts (μV) as follows:&#xD;
Median Nerve Conduction Study:&#xD;
We will measure the sensory nerve action potential (SNAP) amplitude from the second digit.&#xD;
Ulnar Nerve Conduction Study:&#xD;
We will measure the sensory nerve action potential (SNAP) amplitude from the fifth digit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Median and Ulnar nerve distal motor latency post-acupuncture compared to pre-acupuncture</measure>
    <time_frame>Week 1, Week 2</time_frame>
    <description>Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.&#xD;
Specifically, we will measure Median and Ulnar distal motor latency (DML) in milliseconds (msec), defined as the interval between stimulus and onset of Median and Ulnar nerve Compound Muscle Action Potentials (CMAP). Post-acupuncture DML will be compared to pre-acupuncture DML.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Median and Ulnar nerve distal sensory latency post-acupuncture compared to pre-acupuncture</measure>
    <time_frame>Week 1, Week 2</time_frame>
    <description>Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.&#xD;
Specifically, we will measure Median and Ulnar distal sensory latency (DSL) in milliseconds (msec), defined as the interval between stimulus and onset of Median and Ulnar nerve Sensory nerve action potentials (SNAP). Post-acupuncture DSL will be compared to pre-acupuncture DSL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Median and Ulnar nerve nerve conduction velocities (NCV) post-acupuncture compared to pre-acupuncture</measure>
    <time_frame>Week 1, Week 2</time_frame>
    <description>Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.&#xD;
Median and Ulnar nerve nerve conduction velocities (NCV) will be measured in meters/second (m/s). Post-acupuncture NCVs will be compared to pre-acupuncture NCVs.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Manual Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device:&#xD;
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea&#xD;
Used for Intervention:&#xD;
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Frequency Electroacupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device:&#xD;
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA&#xD;
Used for Intervention:&#xD;
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-Frequency Electroacupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device:&#xD;
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA&#xD;
Used for Intervention:&#xD;
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MAC acupuncture needles</intervention_name>
    <description>Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture&#xD;
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min</description>
    <arm_group_label>Manual Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrostimulator 6c.Pro, Pantheon Research, Venice, CA</intervention_name>
    <description>Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture&#xD;
Used for Interventions:&#xD;
Low-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min AND High-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min</description>
    <arm_group_label>High-Frequency Electroacupuncture</arm_group_label>
    <arm_group_label>Low-Frequency Electroacupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of mild-moderate sensorimotor or sensory median neuropathy, established by&#xD;
             pre-existing NCS/EMG study AND&#xD;
&#xD;
          -  Baseline NCS study within the past 2 years, consistent with mild-moderate median&#xD;
             entrapment neuropathy (CTS) defined as meeting any of the 3 conditions below:&#xD;
&#xD;
               1. Prolonged distal Median sensory AND/OR motor latency&#xD;
&#xD;
               2. Reduced Median sensory nerve action potentials (SNAP) amplitude by no more than&#xD;
                  50%&#xD;
&#xD;
               3. Amplitude of the compound muscle action potential (CMAP) recorded from APB &gt; 50%&#xD;
                  of normal&#xD;
&#xD;
          -  Presence of neuropathy symptoms consistent with CTS for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Conditions in which acupuncture/electroacupuncture may be contraindicated:&#xD;
&#xD;
          -  Coagulopathy/ Current anti-coagulation treatment&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  History of CAD or pacemaker insertion&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Presence of any skin condition in the arm, such as dermatitis, bruises, weeping skin,&#xD;
             skin lesions, infected skin, or necrotic skin.&#xD;
&#xD;
        Conditions in which QST testing may be contraindicated:&#xD;
&#xD;
          -  Significant cognitive impairment such as diagnosis of Alzheimer's disease or Mental&#xD;
             Retardation or any other condition interfering with alertness, attention and ability&#xD;
             to participate in QST&#xD;
&#xD;
          -  Hospitalization for anxiety or depression in the past 3 months&#xD;
&#xD;
          -  Current psychiatric diagnoses (other than anxiety or depression)&#xD;
&#xD;
          -  Illicit drug use in the past month&#xD;
&#xD;
          -  Current EtOH abuse (&gt; 2 drinks/day)&#xD;
&#xD;
          -  History of significant neurological disease which may affect sensation, e.g., strokes,&#xD;
             Multiple Sclerosis, or spinal cord disorder&#xD;
&#xD;
          -  Change in neuropathy medications within the past 2 months&#xD;
&#xD;
          -  Change in opioid, benzodiazepines, SSRIs or other sedating medications in the past 2&#xD;
             months&#xD;
&#xD;
        Conditions, which predispose to generalized neuropathy&#xD;
&#xD;
          -  Abnormal thyroid function tests (by history)&#xD;
&#xD;
          -  Past chemotherapy treatment&#xD;
&#xD;
        Other Contraindications:&#xD;
&#xD;
          -  History of wrist or elbow fracture, past arm trauma, loss of fingers, scarring&#xD;
&#xD;
          -  History of carpal tunnel release surgery or any other surgery on the arm or shoulder&#xD;
&#xD;
          -  History of arthritis&#xD;
&#xD;
          -  Use of any investigational drugs within the previous six months&#xD;
&#xD;
        Exclusion Criteria based on NCS within the past 2 years:&#xD;
&#xD;
          -  Presence of isolated motor Median neuropathy (absence of sensory neuropathy on NCS or&#xD;
             absence of sensory symptoms)&#xD;
&#xD;
          -  Severe neuropathy symptoms leading to inability to tolerate acupuncture or QST&#xD;
&#xD;
          -  Presence of Severe Carpal Tunnel Syndrome, defined as:&#xD;
&#xD;
               1. Absent sensory nerve action potential recorded from the second or fifth digit.&#xD;
&#xD;
               2. The amplitude of the compound muscle action potential recorded from the APB or&#xD;
                  ADM is less than 50% of normal (&lt; 2.5 mv)&#xD;
&#xD;
          -  Presence of Ulnar neuropathy&#xD;
&#xD;
          -  Presence of Martin-Gruber anastomosis&#xD;
&#xD;
        Secondary Exclusion Criteria after WEEK 1 Baseline QST and NCS measurements:&#xD;
&#xD;
          -  Failure to comply with QST due to inattentiveness, etc&#xD;
&#xD;
          -  Hyperalgesia on QST&#xD;
&#xD;
          -  Hypoalgesia on QST&#xD;
&#xD;
          -  Inability to confirm diagnosis of mild-moderate CTS (normal NCS)&#xD;
&#xD;
          -  Inability to tolerate NCS/QST&#xD;
&#xD;
          -  Presence Severe CTS&#xD;
&#xD;
          -  Pure Motor Median Neuropathy&#xD;
&#xD;
          -  Ulnar Neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>December 12, 2021</last_update_submitted>
  <last_update_submitted_qc>December 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Alexandra Dimitrova</investigator_full_name>
    <investigator_title>Assistant Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>Electroacupuncture</keyword>
  <keyword>Nerve Conduction Studies</keyword>
  <keyword>Quantitative Sensory Testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 30, 2023</submitted>
    <returned>July 24, 2023</returned>
    <submitted>August 11, 2023</submitted>
    <returned>September 5, 2023</returned>
    <submitted>September 6, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036657
org study id: IRB00008949
nct id: NCT03036657
lead sponsor: 
has dmc: No
Thus study aims to characterize the local, nerve-specific effects of acupuncture on the
      median and ulnar nerves in the forearm, using nerve conduction studies and quantitative
      sensory testing. All participant will have carpal tunnel syndrome and the affected median
      nerve will be compared to the healthy ulnar nerve. Additionally, we aim to compare the local,
      nerve-specific effect of manual acupuncture to that of low-frequency electroacupuncture and
      of high-frequency electroacupuncture.
The purpose of this study is to measure the local effects of acupuncture on the median and
      ulnar nerves in patients with median neuropathy at the wrist (carpal tunnel syndrome), using
      nerve conduction studies (NCS) and quantitative sensory testing (QST) as outcomes. Our
      secondary aim is to compare acupuncture's effect on the functioning of a diseased nerve
      (median nerve in CTS) to its effect on a healthy nerve (ulnar). Additionally, we aim to
      compare the local, nerve-specific effect of manual acupuncture to that of low-frequency
      electroacupuncture and of high-frequency electroacupuncture.

      In a mechanistic study of acupuncture, 60 subjects with carpal tunnel syndrome (CTS) will be
      randomized to manual acupuncture (MA), low-frequency electroacupuncture (LF-EA) and
      high-frequency electroacupuncture (HF-EA) groups. Baseline measurements will consist of QST
      (vibration and cold detection thresholds), as well as NCS of both median and ulnar nerves.
      Then, each group will undergo acupuncture to the median nerve (Pericardium channel points)
      and to the ulnar nerve (Heart channel points), one week apart, order counterbalanced,
      followed by post-acupuncture NCS and QST measurements in both nerves' territories.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Change in Cold Detection Threshold (CDT) post-acupuncture compared to pre-acupuncture
time frame: Week 1, Week 2
description: Cold Detection Threshold (CDT) will be assessed using the Computer-Aided Sensory Evaluator IV (CASE IV) System (WR MEDICAL ELECTRONICS CO. Maplewood, MN, USA).
The CASE IV Thermal Stimulator uses a four-degree-per-second ramp up and down, and is typically operated in a range from 8 degrees to 50 degrees C., with an accuracy of 1.25 to 0.25 degrees C., depending on temperature. For high-magnitude thermal (cooling) stimuli, the absolute temperature is limited to 8 degrees C. Thermal stimuli are approximately 6 seconds in duration. CDT will be assessed over the thenar eminence and hypothenar eminence with the hand on an even surface, supinated and palm facing up.
The CDT will be determined using the 4, 2 and 1 stimulus presentation algorithm, developed by Dyck et al (Dyck PJ, O'Brien PC, Kosanke JL, Gillen DA, Karnes JL. A 4, 2, and 1 stepping algorithm for quick and accurate estimation of cutaneous sensation threshold. Neurology. 1993 Aug;43(8):1508-12.)
measure: Change in Vibration Detection Threshold (VDT) post-acupuncture compared to pre-acupuncture
time frame: Week 1, Week 2
description: VDT will be assessed using the Computer-Aided Sensory Evaluator IV (CASE IV) System (WR MEDICAL ELECTRONICS CO. Maplewood, MN, USA).
Vibration Stimuli will be delivered as 25 discrete levels ranging from 0.0 to 350 micrometers (μm) of displacement, based on previously established "Just Noticeable Difference" (JND) values. Each stimulus is presented with an exponential onset, and turns off with an exponential decay, in order to eliminate the touch-pressure artifact, which is caused by an instantaneous on/off. Stimulation will be delivered to the lateral aspect of the 2nd digit nailbed and the lateral aspect of the 5th digit nailbed, with the hand on an even surface, pronated and palm down.
The VDT will be determined using the 4, 2 and 1 stimulus presentation algorithm. Dyck PJ, O'Brien PC, Kosanke JL, Gillen DA, Karnes JL. A 4, 2, and 1 stepping algorithm for quick and accurate estimation of cutaneous sensation threshold. Neurology. 1993 Aug;43(8):1508-12.
measure: Change in Median and Ulnar nerve CMAP amplitude post-acupuncture compared to pre-acupuncture.
time frame: Week 1, Week 2
description: Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.
The Median and Ulnar nerve Compound Muscle Action Potential (CMAP) amplitude will be measured in millivolts (mV) as follows:
Median Nerve Conduction Study:
We will measure the CMAP amplitude from the Abductor Pollicis Brevis.
Ulnar Nerve Conduction Study:
We will measure the CMAP amplitude from the Abductor Digiti Minimi.
measure: Change in Median and Ulnar SNAP amplitude post-acupuncture compared to pre-acupuncture
time frame: Week 1, Week 2
description: Pre- and Post-acupuncture nerve conduction studies (NCS) will be performed according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32 C, using a heating pad to warm up a cold hand if needed. The Median and Ulnar nerve sensory nerve action potential (SNAP) amplitude will be measured in microvolts (μV) as follows:
Median Nerve Conduction Study:
We will measure the sensory nerve action potential (SNAP) amplitude from the second digit.
Ulnar Nerve Conduction Study:
We will measure the sensory nerve action potential (SNAP) amplitude from the fifth digit.
measure: Change in Median and Ulnar nerve distal motor latency post-acupuncture compared to pre-acupuncture
time frame: Week 1, Week 2
description: Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.
Specifically, we will measure Median and Ulnar distal motor latency (DML) in milliseconds (msec), defined as the interval between stimulus and onset of Median and Ulnar nerve Compound Muscle Action Potentials (CMAP). Post-acupuncture DML will be compared to pre-acupuncture DML.
measure: Change in Median and Ulnar nerve distal sensory latency post-acupuncture compared to pre-acupuncture
time frame: Week 1, Week 2
description: Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.
Specifically, we will measure Median and Ulnar distal sensory latency (DSL) in milliseconds (msec), defined as the interval between stimulus and onset of Median and Ulnar nerve Sensory nerve action potentials (SNAP). Post-acupuncture DSL will be compared to pre-acupuncture DSL.
measure: Change in Median and Ulnar nerve nerve conduction velocities (NCV) post-acupuncture compared to pre-acupuncture
time frame: Week 1, Week 2
description: Nerve conduction studies (NCS) will be performed pre- and post-acupuncture, according to OHSU's EMG laboratory guidelines, using the Dantec Keypoint® G4 Workstation (Natus Medical Incorporated). Subject skin temperature will be maintained above 32C, using a heating pad to warm up a cold hand if needed.
Median and Ulnar nerve nerve conduction velocities (NCV) will be measured in meters/second (m/s). Post-acupuncture NCVs will be compared to pre-acupuncture NCVs.
arm group label: Manual Acupuncture
arm group type: Experimental
description: Device:
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea
Used for Intervention:
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
arm group label: Low-Frequency Electroacupuncture
arm group type: Experimental
description: Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min
arm group label: High-Frequency Electroacupuncture
arm group type: Experimental
description: Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min
intervention type: Device
intervention name: MAC acupuncture needles
description: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
arm group label: Manual Acupuncture
intervention type: Device
intervention name: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
description: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min AND High-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min
arm group label: High-Frequency Electroacupuncture
arm group label: Low-Frequency Electroacupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Alexandra Dimitrova
investigator title: Assistant Professor of Neurology
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
submitted: June 30, 2023
returned: July 24, 2023
submitted: August 11, 2023
returned: September 5, 2023
submitted: September 6, 2023