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Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

M

Martinos Center for Biomedical Imaging

Status and phase

Unknown
Early Phase 1

Conditions

Carpal Tunnel Syndrome

Treatments

Procedure: electro-acupuncture

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01345994
R01AT004714-01 (U.S. NIH Grant/Contract)
AT004714

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Male and female adults aged 20-60.

  2. 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
  3. 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)
  4. 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

  1. Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
  2. History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
  3. History of rheumatoid arthritis.
  4. History of wrist fracture with direct trauma to median nerve.
  5. Current usage of prescriptive opioid pain medication.
  6. Severe thenar atrophy.
  7. Nerve entrapment other than median nerve.
  8. Cervical radiculopathy or myelopathy.
  9. Generalized peripheral neuropathy.
  10. A blood dyscrasia or coagulopathy or current use of anticoagulation therapy

Trial design

0 participants in 2 patient groups

Acupuncture - local
Experimental group
Description:
acupuncture on forearm only
Treatment:
Procedure: electro-acupuncture
acupuncture - distal
Experimental group
Description:
acupuncture on both arm and leg
Treatment:
Procedure: electro-acupuncture

Trial contacts and locations

1

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Central trial contact

Pia Hugus

Data sourced from clinicaltrials.gov

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