Carpal Tunnel Syndrome
Conditions
Keywords
Acupuncture, Electroacupuncture, Nerve Conduction Studies, Quantitative Sensory Testing
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.
Interventions
DEVICEMAC 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
DEVICEElectrostimulator 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
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated | Week 1, Week 2 | 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 | Week 1, Week 2 | 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 | Week 1, Week 2 | 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 | Week 1, Week 2 | This is the mean plus standard deviation change in CDT in the sensory territory of the ulnar nerve when the ulnar nerve is treated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 20 |
| 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
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 | 20 |
| 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
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 | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Manual Acupuncture | Total | High-Frequency Electroacupuncture | Low-Frequency Electroacupuncture |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 12 Participants | 5 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 48 Participants | 15 Participants | 16 Participants |
| Age, Continuous | 52.05 Years STANDARD_DEVIATION 13.33 | 52.15 Years STANDARD_DEVIATION 14.92 | 55.50 Years STANDARD_DEVIATION 13.92 | 48.90 Years STANDARD_DEVIATION 17.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 58 Participants | 20 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Median Cold Detection Threshold | 8.0 JND (just noticeable difference) STANDARD_DEVIATION 2.3 | 8.2 JND (just noticeable difference) STANDARD_DEVIATION 1.9 | 7.8 JND (just noticeable difference) STANDARD_DEVIATION 1.6 | 8.6 JND (just noticeable difference) STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 56 Participants | 18 Participants | 19 Participants |
| Region of Enrollment United States | 20 participants | 60 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 16 Participants | 48 Participants | 16 Participants | 16 Participants |
| Sex: Female, Male Male | 4 Participants | 12 Participants | 4 Participants | 4 Participants |
| Ulnar Cold Detection Threshold | 10.1 JND (Just Noticeable Difference) STANDARD_DEVIATION 2.2 | 10.4 JND (Just Noticeable Difference) STANDARD_DEVIATION 2.1 | 10.2 JND (Just Noticeable Difference) STANDARD_DEVIATION 2 | 10.8 JND (Just Noticeable Difference) STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Week 1, Week 2
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Manual Acupuncture | Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated | 0.73 JND (just noticeable difference) | Standard Deviation 1.527 |
| Low-Frequency Electroacupuncture | Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated | -0.195 JND (just noticeable difference) | Standard Deviation 1.698 |
| High-Frequency Electroacupuncture | Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated | 0.865 JND (just noticeable difference) | Standard Deviation 2.021 |
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.
Time frame: Week 1, Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Acupuncture | Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated | -0.37 JND | Standard Deviation 1.309 |
| Low-Frequency Electroacupuncture | Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated | 0.23 JND | Standard Deviation 1.358 |
| High-Frequency Electroacupuncture | Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated | 0.23 JND | Standard Deviation 1.627 |
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.
Time frame: Week 1, Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Acupuncture | Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated | 0.215 JND | Standard Deviation 1.732 |
| Low-Frequency Electroacupuncture | Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated | 0.07 JND | Standard Deviation 1.264 |
| High-Frequency Electroacupuncture | Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated | 0.375 JND | Standard Deviation 1.064 |
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.
Time frame: Week 1, Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Acupuncture | Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated | -0.68 JND | Standard Deviation 1.626 |
| Low-Frequency Electroacupuncture | Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated | 0.30 JND | Standard Deviation 1.182 |
| High-Frequency Electroacupuncture | Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated | 0.405 JND | Standard Deviation 0.99 |