Local Effects of Acupuncture and Nerve Conduction Studies

NCT ID: NCT03036657

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-12-31

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

MAC acupuncture needles

Intervention Type: 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Dimitrova

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30611294 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IRB00008949

Identifier Type: -

Identifier Source: org_study_id