Local Effects of Acupuncture and Nerve Conduction Studies

Carpal Tunnel Syndrome Clinical Trial

Official title:

Local Effects of Acupuncture on the Median and Ulnar Nerves in Patients With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036657
• Other study ID #: IRB00008949
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2021

Study information

• Verified date: October 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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