Local Effects of Acupuncture and Nerve Conduction Studies

NCT03036657 | Completed Results

• 1 other identifier: IRB00008949
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Acupuncture; Electroacupuncture; Nerve Conduction Studies; Quantitative Sensory Testing

Outcome Measures

Primary Outcomes (4)

• Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated

  The median change plus standard deviation when the median nerve was treated and CDT was measured in the sensory distribution of the median nerve. The CDT is measured in CASE IV - specific units named Just Noticeable Difference (JND). The CASE IV System uses a set of 25 standardized vibratory and thermal stimulation levels for patient testing and analysis. These 25 levels are termed "Just Noticeable Differences" or "JNDs," and are similar to decibels. The concept of a JND is based on the fact that a sensitive person can detect fine differences between two levels of stimulation, whereas an insensitive person cannot. Because differences of less than one JND are difficult to distinguish, one JND is the smallest difference presented to patients. Stimuli based on the JND scale can be used to test patients very efficiently and quickly, without compromising the significance of the clinical result.

  Week 1, Week 2

• Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated

  This is the mean change plus standard deviation in CDT in the sensory distribution of the ulnar never when the median nerve is treated. The CDT is measured in CASE IV - specific units named Just Noticeable Difference (JND). The CASE IV System uses a set of 25 standardized vibratory and thermal stimulation levels for patient testing and analysis. These 25 levels are termed "Just Noticeable Differences" or "JNDs," and are similar to decibels. The concept of a JND is based on the fact that a sensitive person can detect fine differences between two levels of stimulation, whereas an insensitive person cannot. Because differences of less than one JND are difficult to distinguish, one JND is the smallest difference presented to patients. Stimuli based on the JND scale can be used to test patients very efficiently and quickly, without compromising the significance of the clinical result.

  Week 1, Week 2

• Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated

  This is the mean change plus standard deviation in the sensory territory of the Median nerve when the Ulnar nerve was treated.

  Week 1, Week 2

• Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated

  This is the mean plus standard deviation change in CDT in the sensory territory of the ulnar nerve when the ulnar nerve is treated.

  Week 1, Week 2

Study Arms (3)

Manual Acupuncture

EXPERIMENTAL

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

Low-Frequency Electroacupuncture

EXPERIMENTAL

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

High-Frequency Electroacupuncture

EXPERIMENTAL

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

Interventions

MAC acupuncture needles 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 Manual Acupuncture Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min

Manual Acupuncture

Electrostimulator 6c.Pro, Pantheon Research, Venice, CA DEVICE

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

High-Frequency Electroacupuncture; Low-Frequency Electroacupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Prolonged distal Median sensory AND/OR motor latency
• Reduced Median sensory nerve action potentials (SNAP) amplitude by no more than 50%
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 30611294 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Results Point of Contact

• Title: Alexandra Dimitrova, PI
• Organization: Oregon Health & Science University

dimitroa@ohsu.edu

503-494-0766

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: January 30, 2017
• Study Start: October 1, 2015
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-10

Locations

US (1)