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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00514462
Other study ID # CS07040
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received August 8, 2007
Last updated August 9, 2007
Start date July 2007
Est. completion date August 2007

Study information

Verified date August 2007
Source Chung Shan Medical University
Contact Yu-Chun Yeh, Ph.D
Phone 886922002769
Email mandy-steven@yahoo.com.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
diode laser
wavelength at 830nm, 9.7J/cm2 for 10 min

Locations

Country Name City State
China Chung Shan Medical University Hospital Chinese Taipei Taiwan

Sponsors (2)

Lead Sponsor Collaborator
Chung Shan Medical University National Taiwan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary treatment effect two weeks
Secondary EMG, Jamar dynamometer, Carpal tunnel function disability form two weeks
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