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Local Effects of Acupuncture and Nerve Conduction Studies

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ClinicalTrials.gov Identifier: NCT03036657
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Alexandra Dimitrova, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE August 14, 2016
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date April 10, 2018
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Change in Cold Detection Threshold (CDT) post-acupuncture compared to pre-acupuncture [ Time Frame: Week 1, Week 2 ]
    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.)
  • Change in Vibration Detection Threshold (VDT) post-acupuncture compared to pre-acupuncture [ Time Frame: Week 1, Week 2 ]
    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.
  • Change in Median and Ulnar nerve CMAP amplitude post-acupuncture compared to pre-acupuncture. [ Time Frame: Week 1, Week 2 ]
    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.
  • Change in Median and Ulnar SNAP amplitude post-acupuncture compared to pre-acupuncture [ Time Frame: Week 1, Week 2 ]
    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.
  • Change in Median and Ulnar nerve distal motor latency post-acupuncture compared to pre-acupuncture [ Time Frame: Week 1, Week 2 ]
    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.
  • Change in Median and Ulnar nerve distal sensory latency post-acupuncture compared to pre-acupuncture [ Time Frame: Week 1, Week 2 ]
    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.
  • Change in Median and Ulnar nerve nerve conduction velocities (NCV) post-acupuncture compared to pre-acupuncture [ Time Frame: Week 1, Week 2 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03036657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Effects of Acupuncture and Nerve Conduction Studies
Official Title  ICMJE Local Effects of Acupuncture on the Median and Ulnar Nerves in Patients With Carpal Tunnel Syndrome
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Device: MAC acupuncture needles

    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

  • Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA

    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

Study Arms  ICMJE
  • Experimental: Manual Acupuncture

    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

    Intervention: Device: MAC acupuncture needles
  • Experimental: Low-Frequency Electroacupuncture

    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

    Intervention: Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
  • Experimental: High-Frequency Electroacupuncture

    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: Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Publications * Dimitrova A, Murchison C, Oken B. Local effects of acupuncture on the median and ulnar nerves in patients with carpal tunnel syndrome: a pilot mechanistic study protocol. Trials. 2019 Jan 5;20(1):8. doi: 10.1186/s13063-018-3094-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presence of mild-moderate sensorimotor or sensory median neuropathy, established by pre-existing NCS/EMG study AND
  • Baseline NCS study within the past 2 years, consistent with mild-moderate median entrapment neuropathy (CTS) defined as meeting any of the 3 conditions below:

    1. Prolonged distal Median sensory AND/OR motor latency
    2. Reduced Median sensory nerve action potentials (SNAP) amplitude by no more than 50%
    3. Amplitude of the compound muscle action potential (CMAP) recorded from APB > 50% of normal
  • Presence of neuropathy symptoms consistent with CTS for at least 3 months

Exclusion Criteria:

Conditions in which acupuncture/electroacupuncture may be contraindicated:

  • Coagulopathy/ Current anti-coagulation treatment
  • Epilepsy
  • History of CAD or pacemaker insertion
  • Pregnancy
  • Presence of any skin condition in the arm, such as dermatitis, bruises, weeping skin, skin lesions, infected skin, or necrotic skin.

Conditions in which QST testing may be contraindicated:

  • Significant cognitive impairment such as diagnosis of Alzheimer's disease or Mental Retardation or any other condition interfering with alertness, attention and ability to participate in QST
  • Hospitalization for anxiety or depression in the past 3 months
  • Current psychiatric diagnoses (other than anxiety or depression)
  • Illicit drug use in the past month
  • Current EtOH abuse (> 2 drinks/day)
  • History of significant neurological disease which may affect sensation, e.g., strokes, Multiple Sclerosis, or spinal cord disorder
  • Change in neuropathy medications within the past 2 months
  • Change in opioid, benzodiazepines, SSRIs or other sedating medications in the past 2 months

Conditions, which predispose to generalized neuropathy

  • Abnormal thyroid function tests (by history)
  • Past chemotherapy treatment

Other Contraindications:

  • History of wrist or elbow fracture, past arm trauma, loss of fingers, scarring
  • History of carpal tunnel release surgery or any other surgery on the arm or shoulder
  • History of arthritis
  • Use of any investigational drugs within the previous six months

Exclusion Criteria based on NCS within the past 2 years:

  • Presence of isolated motor Median neuropathy (absence of sensory neuropathy on NCS or absence of sensory symptoms)
  • Severe neuropathy symptoms leading to inability to tolerate acupuncture or QST
  • Presence of Severe Carpal Tunnel Syndrome, defined as:

    1. Absent sensory nerve action potential recorded from the second or fifth digit.
    2. The amplitude of the compound muscle action potential recorded from the APB or ADM is less than 50% of normal (< 2.5 mv)
  • Presence of Ulnar neuropathy
  • Presence of Martin-Gruber anastomosis

Secondary Exclusion Criteria after WEEK 1 Baseline QST and NCS measurements:

  • Failure to comply with QST due to inattentiveness, etc
  • Hyperalgesia on QST
  • Hypoalgesia on QST
  • Inability to confirm diagnosis of mild-moderate CTS (normal NCS)
  • Inability to tolerate NCS/QST
  • Presence Severe CTS
  • Pure Motor Median Neuropathy
  • Ulnar Neuropathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandra Dimitrova, MD, MA, MCR 503-494-0744 dimitroa@ohsu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036657
Other Study ID Numbers  ICMJE IRB00008949
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandra Dimitrova, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oregon Health and Science University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP