NCT00514462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
Last Updated

August 10, 2007

Status Verified

August 1, 2007

First QC Date

August 8, 2007

Last Update Submit

August 9, 2007

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • treatment effect

    two weeks

Secondary Outcomes (1)

  • EMG, Jamar dynamometer, Carpal tunnel function disability form

    two weeks

Study Arms (1)

A

EXPERIMENTAL

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

Device: diode laser

Interventions

diode laserDEVICE

wavelength at 830nm, 9.7J/cm2 for 10 min

Also known as: Low-level laser
A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Chinese Taipei, Taiwan, 360, China

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Lasers, SemiconductorLow-Level Light Therapy

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesLaser TherapyTherapeuticsPhototherapy

Study Officials

  • Chin-Ping Han, MD/PhD

    Chung Shan Medical University

    STUDY DIRECTOR

Central Study Contacts

Yu-Chun Yeh, Ph.D

CONTACT

886922002769mandy-steven@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 10, 2007

Study Start

July 1, 2007

Study Completion

August 1, 2007

Last Updated

August 10, 2007

Record last verified: 2007-08

Locations

CN(1)