Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Local Effects of Acupuncture and Nerve Conduction Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036657
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandra Dimitrova, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: MAC acupuncture needles Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Local Effects of Acupuncture on the Median and Ulnar Nerves in Patients With Carpal Tunnel Syndrome
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
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

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


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

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


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

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





Primary Outcome Measures :
  1. 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.)


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03036657


Contacts
Layout table for location contacts
Contact: Alexandra Dimitrova, MD, MA, MCR 503-494-0744 dimitroa@ohsu.edu

Locations
Layout table for location information
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Alexandra Dimitrova, MD, MA, MCR    503-494-0744    dimitroa@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alexandra Dimitrova, Assistant Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03036657     History of Changes
Other Study ID Numbers: IRB00008949
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

Keywords provided by Alexandra Dimitrova, Oregon Health and Science University:
Acupuncture
Electroacupuncture
Nerve Conduction Studies
Quantitative Sensory Testing

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries