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Carpal Tunnel Syndrome Treated With 830nm Diode Laser (CTS)

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
diode laser
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • no operation of the wrist
  • first onset of CTS more than 1 year ago with repeated episodes
  • never having laser treatment before.

Exclusion Criteria:

  • patients with any rheumatoid arthritis
  • history of metabolic disease or paralyzed limbs caused by stroke
  • taking any anti-inflammatory drug
  • with other treatments, such as acupuncture, physical therapy and wearing orthosis

Sites / Locations

  • Chung Shan Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA)

Outcomes

Primary Outcome Measures

treatment effect

Secondary Outcome Measures

EMG, Jamar dynamometer, Carpal tunnel function disability form

Full Information

First Posted
August 8, 2007
Last Updated
August 9, 2007
Sponsor
Chung Shan Medical University
Collaborators
National Taiwan University
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1. Study Identification

Unique Protocol Identification Number
NCT00514462
Brief Title
Carpal Tunnel Syndrome Treated With 830nm Diode Laser
Acronym
CTS
Official Title
Instiutional Review Board of Chung Shan Medical University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chung Shan Medical University
Collaborators
National Taiwan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine that 830nm diode laser directly above the transverse carpal ligament (between the pisiform and navicular bone) on subjects' wrists, and test this therapeutic effect.
Detailed Description
The low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA) emitted two light beams with a distance of 2.5cm between them by two laser diodes.

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

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA)
Intervention Type
Device
Intervention Name(s)
diode laser
Other Intervention Name(s)
Low-level laser
Intervention Description
wavelength at 830nm, 9.7J/cm2 for 10 min
Primary Outcome Measure Information:
Title
treatment effect
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
EMG, Jamar dynamometer, Carpal tunnel function disability form
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: no operation of the wrist first onset of CTS more than 1 year ago with repeated episodes never having laser treatment before. Exclusion Criteria: patients with any rheumatoid arthritis history of metabolic disease or paralyzed limbs caused by stroke taking any anti-inflammatory drug with other treatments, such as acupuncture, physical therapy and wearing orthosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chun Yeh, Ph.D
Phone
886922002769
Email
mandy-steven@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Ping Han, MD/PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Chinese Taipei
State/Province
Taiwan
ZIP/Postal Code
360
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe-Air Jiang, Ph.D
Phone
886-2-33665341
Email
jajiang@ntu.edu.tw

12. IPD Sharing Statement

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Carpal Tunnel Syndrome Treated With 830nm Diode Laser

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