Carpal Tunnel SyndromeNCT03036657
Local Effects of Acupuncture and Nerve Conduction Studies
A study testing MAC acupuncture needles and Electrostimulator 6c.Pro, Pantheon Research, Venice, CA in people with Carpal Tunnel Syndrome, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- MAC acupuncture needles and Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 39Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Local Effects of Acupuncture on the Median and Ulnar Nerves in Patients With Carpal Tunnel Syndrome
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.
Read the 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
- Being tested
- MAC acupuncture needles, Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
- Keywords
- Acupuncture, Electroacupuncture, Nerve Conduction Studies, Quantitative Sensory Testing
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAC acupuncture needlesDevice
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, CADevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startOct 2015
- Primary completionMay 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Dimitrova, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036657
- Sponsor's protocol ID
- IRB00008949
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2016
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30611294
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Effects of Acupuncture on the Median and Ulnar Nerves in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03036657
- Acronym / sponsor ID
- IRB00008949
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Acupuncture, Electroacupuncture, Nerve Conduction Studies, Quantitative Sensory Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Acupuncture | Experimental | Device: MAC acupuncture needlesDevice: 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 |
| Low-Frequency Electroacupuncture | Experimental | Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CADevice: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA Used for Intervention: Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min |
| High-Frequency Electroacupuncture | Experimental | Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CADevice: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Presence of neuropathy symptoms consistent with CTS for at least 3 months
Key exclusion criteria (39 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAC acupuncture needlesSterile 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 | Device | Manual Acupuncture |
| Electrostimulator 6c.Pro, Pantheon Research, Venice, CAElectrostimulator 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 | Device | High-Frequency Electroacupuncture, Low-Frequency Electroacupuncture |
Primary outcome
Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30611294Dimitrova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAC acupuncture needles and Electrostimulator 6c.Pro, Pantheon Research, Venice, CA in people with Carpal Tunnel Syndrome, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated (time frame: Week 1, Week 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.