Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture
Recruitment status was Recruiting
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Purpose
This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population.
| Condition | Intervention | Phase |
|---|---|---|
|
Carpal Tunnel Syndrome |
Procedure: electro-acupuncture |
Phase 0 |
| Study Type: | Interventional |
- Functional MRI brain response [ Time Frame: Baseline vs. Post-Acupuncture (average 9 weeks later) ] [ Designated as safety issue: No ]Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acupuncture - local
acupuncture on forearm only
|
Procedure: electro-acupuncture
acupuncture stimulation with electricity
|
|
Experimental: acupuncture - distal
acupuncture on both arm and leg
|
Procedure: electro-acupuncture
acupuncture stimulation with electricity
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male and female adults aged 20-60.
History
- Pain and/or paresthesia in median nerve distribution (i.e., numbness in some combination of digit 1, 2, 3, and the radial part of digit 4)
- Nocturnal pain and/or paresthesia in median nerve distribution
- Symptoms (a and b) greater than 3 months in duration
Physical Exam with two of the following three findings:
- Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)
- Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)
- Nerve conduction findings consistent with mild to severe CTS:
Mild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (> 3.7milliseconds and/or > than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions
Moderate CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with delayed distal latency of the motor conductions across the wrist (> 4.2 milliseconds).
Severe CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with greater than 50% loss of motor amplitudes (relative to unaffected side and/or normative range).
Exclusion Criteria:
- Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
- History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
- History of rheumatoid arthritis.
- History of wrist fracture with direct trauma to median nerve.
- Current usage of prescriptive opioid pain medication.
- Severe thenar atrophy.
- Nerve entrapment other than median nerve.
- Cervical radiculopathy or myelopathy.
- Generalized peripheral neuropathy.
- A blood dyscrasia or coagulopathy or current use of anticoagulation therapy
Contacts and Locations| Contact: Pia Hugus | 781-391-7518 ext 306 |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02129 | |
| Contact: Pia Hugus 781-391-7518 ext 306 | |
| Principal Investigator: Vitaly Napadow, PhD | |
More Information
No publications provided
| Responsible Party: | Vitaly Napadow, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01345994 History of Changes |
| Other Study ID Numbers: | AT004714, R01AT004714-01 |
| Study First Received: | April 25, 2011 |
| Last Updated: | April 29, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Carpal Tunnel Syndrome Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013