Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

Early Phase 1

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: electro-acupuncture

• Registration Number: NCT01345994
• Lead Sponsor: Martinos Center for Biomedical Imaging

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Status Verified: 2011-03
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-29
• Last Update Submitted: 2011-04-29
• Study First Posted: 2011-05-02
• Last Update Posted: 2011-05-02
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acupuncture - local	electro-acupuncture	acupuncture on forearm only
acupuncture - distal	electro-acupuncture	acupuncture on both arm and leg

Primary Outcome Measures

Name	Time	Method
Functional MRI brain response	Baseline vs. Post-Acupuncture (average 9 weeks later)	Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States