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Local Effects of Acupuncture and Nerve Conduction Studies

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAC acupuncture needles
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carpal Tunnel Syndrome focused on measuring Acupuncture, Electroacupuncture, Nerve Conduction Studies, Quantitative Sensory Testing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Manual Acupuncture

Low-Frequency Electroacupuncture

High-Frequency Electroacupuncture

Arm 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

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 Used for Intervention: High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2016
Last Updated
October 5, 2023
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03036657
Brief Title
Local Effects of Acupuncture and Nerve Conduction Studies
Official Title
Local Effects of Acupuncture on the Median and Ulnar Nerves in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Acupuncture, Electroacupuncture, Nerve Conduction Studies, Quantitative Sensory Testing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Acupuncture
Arm Type
Experimental
Arm 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 Title
Low-Frequency Electroacupuncture
Arm Type
Experimental
Arm 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 Title
High-Frequency Electroacupuncture
Arm Type
Experimental
Arm 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(s)
MAC acupuncture needles
Intervention 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
Intervention Type
Device
Intervention Name(s)
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Intervention 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
Primary Outcome Measure Information:
Title
Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated
Description
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.
Time Frame
Week 1, Week 2
Title
Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated
Description
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.
Time Frame
Week 1, Week 2
Title
Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated
Description
This is the mean change plus standard deviation in the sensory territory of the Median nerve when the Ulnar nerve was treated.
Time Frame
Week 1, Week 2
Title
Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated
Description
This is the mean plus standard deviation change in CDT in the sensory territory of the ulnar nerve when the ulnar nerve is treated.
Time Frame
Week 1, Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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 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: Absent sensory nerve action potential recorded from the second or fifth digit. 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
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30611294
Citation
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.
Results Reference
derived

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Local Effects of Acupuncture and Nerve Conduction Studies

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