Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

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.

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: electro-acupuncture

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Pia Hugus; Phone Number: 306 781-391-7518

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Pia Hugus; Phone Number: 306 781-391-7518

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Martinos Center for Biomedical Imaging
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 29, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: AT004714; R01AT004714-01 (U.S. NIH Grant/Contract)