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Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

Primary Purpose

Carpal Tunnel Syndrome

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

electro-acupuncture

About this trial

This is an interventional trial for Carpal Tunnel Syndrome

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female adults aged 20-60.
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
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)
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:

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Acupuncture - local

acupuncture - distal

Arm Description

acupuncture on forearm only

acupuncture on both arm and leg

Outcomes

Primary Outcome Measures

Functional MRI brain response

Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy

Secondary Outcome Measures

Full Information

NCT ID

NCT01345994

First Posted

April 25, 2011

Last Updated

April 29, 2011

Sponsor

Martinos Center for Biomedical Imaging

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT01345994

Brief Title

Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Martinos Center for Biomedical Imaging

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

7. Study Design

Study Phase

Early Phase 1

8. Arms, Groups, and Interventions

Arm Title

Acupuncture - local

Arm Type

Experimental

Arm Description

acupuncture on forearm only

Arm Title

acupuncture - distal

Arm Type

Experimental

Arm Description

acupuncture on both arm and leg

Intervention Type

Procedure

Intervention Name(s)

electro-acupuncture

Intervention Description

acupuncture stimulation with electricity

Primary Outcome Measure Information:

Title

Functional MRI brain response

Description

Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy

Time Frame

Baseline vs. Post-Acupuncture (average 9 weeks later)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female adults aged 20-60. 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 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) 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: Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center) History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses. History of rheumatoid arthritis. History of wrist fracture with direct trauma to median nerve. Current usage of prescriptive opioid pain medication. Severe thenar atrophy. Nerve entrapment other than median nerve. Cervical radiculopathy or myelopathy. Generalized peripheral neuropathy. A blood dyscrasia or coagulopathy or current use of anticoagulation therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pia Hugus

Phone

781-391-7518

Ext

306

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pia Hugus

Phone

781-391-7518

Ext

306

First Name & Middle Initial & Last Name & Degree

Vitaly Napadow, PhD

12. IPD Sharing Statement

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Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

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