Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

Carpal Tunnel Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01345994
• Other study ID #: AT004714
• Secondary ID: R01AT004714-01
• Status: Recruiting
• Phase: Phase 0
• First received: April 25, 2011
• Last updated: April 29, 2011
• Start date: May 2009
• Est. completion date: May 2013

Study information

• Verified date: March 2011
• Source: Martinos Center for Biomedical Imaging
• Contact: Pia Hugus
• Phone: 781-391-7518
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Procedure:
• electro-acupuncture
acupuncture stimulation with electricity

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Martinos Center for Biomedical Imaging	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional MRI brain response	Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy	Baseline vs. Post-Acupuncture (average 9 weeks later)	No