Carpal Tunnel SyndromePhase 1/2CTSNCT00514462
Carpal Tunnel Syndrome Treated With 830nm Diode Laser
A Phase 1/2 study testing diode laser in people with Carpal Tunnel Syndrome, run by Chung Shan Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Aug 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no operation of the wrist
- first onset of CTS more than 1 year ago with repeated episodes
- never having laser treatment before.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Chinese Taipei, Taiwan, 360
Joe-Air Jiang, Ph.D, 886-2-33665341, jajiang@ntu.edu.tw
About this study
Official title: Instiutional Review Board of Chung Shan Medical University Hospital
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- diode laser
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laserDevice
Also called Low-level laser
wavelength at 830nm, 9.7J/cm2 for 10 min
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | low level laser instrument (Painless Light PL-830, Advanced Chips \& Products Crop., USA) Receives: Device: diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment effect
Measured: two weeks
Secondary outcomes (1)
EMG, Jamar dynamometer, Carpal tunnel function disability form
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startJul 2007
- Study completionAug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Investigators
- Chin-Ping Han, MD/PhD, Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514462
- Sponsor's protocol ID
- CS07040
- Acronym
- CTS
- Status last verified
- Aug 2007
- First submitted
- 8 Aug 2007
- Last updated
- 10 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instiutional Review Board of Chung Shan Medical University Hospital
- ClinicalTrials.gov ID
- NCT00514462
- Acronym / sponsor ID
- CTS / CS07040
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- Jul 2007
- Study completion
- Aug 2007 (estimated)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: diode laserlow level laser instrument (Painless Light PL-830, Advanced Chips \& Products Crop., USA) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no operation of the wrist
- first onset of CTS more than 1 year ago with repeated episodes
- never having laser treatment before.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diode laserAlso: Low-level laserwavelength at 830nm, 9.7J/cm2 for 10 min | Device | A |
Primary outcome
treatment effect
Time frame: two weeks
1 secondary outcome
EMG, Jamar dynamometer, Carpal tunnel function disability form
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Ping Han, MD/PhD study director
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing diode laser in people with Carpal Tunnel Syndrome, run by Chung Shan Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chun Yeh, Ph.D (886922002769, mandy-steven@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment effect (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2007.