Recruiting
Early Phase 1

Acupuncture

Sponsor:

Martinos Center for Biomedical Imaging

Code:

NCT01345994

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

electro-acupuncture

Study Details

Brief summary:

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT01345994

Start date

May, 2009

Status verified date

Mar, 2011

Completion date

May, 2013

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

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

Study Design

Interventions and Outcome Measures

Arms

experimental: Acupuncture - local

acupuncture on forearm only

experimental: acupuncture - distal

acupuncture on both arm and leg

Interventions

electro-acupuncture

acupuncture stimulation with electricity

Primary outcome measure

  • Functional MRI brain response [ Time Frame: Baseline vs. Post-Acupuncture (average 9 weeks later) ]

Central Contacts and Locations

Central contacts

Pia Hugus

781-391-7518

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Pia Hugus

781-391-7518

Principal Investigator:

Vitaly Napadow, PhD

More Information

Sponsor

Martinos Center for Biomedical Imaging

Last update posted

May 2, 2011

Last verified

Mar, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Martinos Center for Biomedical Imaging on 2011-05-02.