Carpal Tunnel Syndrome Treated With 830nm Diode Laser | NCT00514462

Studies
Carpal Tunnel Syndrome Treated With 830nm Diode Laser

NCT00514462

Sponsor

Chung Shan Medical University

Status

Unknown status

Last Update Posted

Aug 10, 2007Estimated

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Carpal Tunnel Syndrome

Interventions

diode laser

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Aug 2007Estimated

First Submitted Date

Aug 8, 2007

First Submission Date that Met QC Criteria

Aug 9, 2007

First Posted Date

Aug 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2007

Last Update Posted Date

Aug 10, 2007Estimated

Name	Class
National Taiwan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA)	Device: diode laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diode laser	Device	wavelength at 830nm, 9.7J/cm2 for 10 min	A	Low-level laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment effect		two weeks

Secondary Outcomes

Measure	Description	Time Frame
EMG, Jamar dynamometer, Carpal tunnel function disability form		two weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu-Chun Yeh, Ph.D	Contact	886922002769		mandy-steven@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Chin-Ping Han, MD/PhD	Chung Shan Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung Shan Medical University Hospital	Recruiting	Chinese Taipei	Taiwan	360	China

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054023	Lasers, Semiconductor
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided