Carpal Tunnel SyndromeNCT05678595
The Effect of High-intensity Laser Therapy in Patients With Carpal Tunnel Syndrome.
A study testing high-intensity laser therapy in people with Carpal Tunnel Syndrome, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on pain, functional status, hand grip strength and median nerve cross-sectional area in ultrasonography in patients with carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- high-intensity laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 23 Jun 2023
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Electrophysiologically mild or moderate CTS
- Patients who are literate and able to understand verbal instructions in our
Who cannot join
- Diabetes
- Systemic disorders that may affect treatment such as hypothyroidism, SLE, gout
- History of polyneuropathy, cervical radiculopathy, brachial plexopathy
- Injection for the carpal tunnel in the last 1 month
- History of severe trauma, fracture, operation to both upper extremities at any time
- Malignancy or history of malignancy
Show all 10Show fewer
- Renal failure
- Peripheral or central nervous system diseases
- Pregnancy
- History of physical therapy program for the same hand wrist in the last months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-intensity Laser Therapy on Pain, Functional Status, Hand Grip Strength and Median Nerve Cross-sectional Area in Ultrasonography in Patients With Carpal Tunnel Syndrome.
The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on pain, functional status, hand grip strength and median nerve cross-sectional area in ultrasonography in patients with carpal tunnel syndrome.
Read the detailed description
Patients who are admitted and diagnosed with carpal tunnel syndrome based on anamnesis, physical examination and electromyography are included in the study.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- high-intensity laser therapy, sham high-intensity laser therapy
- Keywords
- pain, High-intensity laser therapy, ultrasonography
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity laser therapyDevice
HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given.
sham high-intensity laser therapyDevice
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| A hot laser derived from a Nd: YAG laser | Active comparator | HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given. Receives: Device: high-intensity laser therapy; Device: sham high-intensity laser therapy |
| sham high-intensity laser therapy | Sham comparator | HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions. Receives: Device: high-intensity laser therapy; Device: sham high-intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain.
Measured: Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]
Secondary outcomes (3)
Boston Carpal Tunnel Questionnaire
The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult.
Measured: Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.
Hand Grip Force Measurement Test
A hydraulic hand dynamometer (Jamar) will be used in the measurements. Three measurements will be made with the elbow flexed and connected to the body, and the forearm in a neutral position. The measurements will be averaged in kg-f and recorded in the study form.
Measured: Baseline- week 2- week 12
The cross-sectional area of the median nerve
The cross-sectional area of the median nerve will be measured by USG at the level of the pisiform bone (proximal carpal tunnel). While the patient is in a sitting position, the arm on the measuring side will be positioned semiflexed, elbow semiflexed, forearm supinated, fingers semi-flexed, and wrist on a flat surface.
Measured: Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Dec 2022
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
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.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Ordahan, Necmettin Erbakan University
- Investigators
- BANU ORDAHAN, Principal investigator, Meram Medical School, Necmettin Erbakan University, Konya, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678595
- Sponsor's protocol ID
- fatih yiğit
- Status last verified
- Jun 2023
- First submitted
- 2 Jan 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-intensity Laser Therapy on Pain, Functional Status, Hand Grip Strength and Median Nerve Cross-sectional Area in Ultrasonography in Patients With Carpal Tunnel Syndrome.
- ClinicalTrials.gov ID
- NCT05678595
- Acronym / sponsor ID
- fatih yiğit
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- pain, High-intensity laser therapy, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- 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 aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on pain, functional status, hand grip strength and median nerve cross-sectional area in ultrasonography in patients with carpal tunnel syndrome.
Detailed description
Patients who are admitted and diagnosed with carpal tunnel syndrome based on anamnesis, physical examination and electromyography are included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A hot laser derived from a Nd: YAG laser | Active comparator | Device: high-intensity laser therapy, Device: sham high-intensity laser therapyHILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given. |
| sham high-intensity laser therapy | Sham comparator | Device: high-intensity laser therapy, Device: sham high-intensity laser therapyHILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Electrophysiologically mild or moderate CTS
- Patients who are literate and able to understand verbal instructions in our
Key exclusion criteria (10 listed)
- Diabetes
- Systemic disorders that may affect treatment such as hypothyroidism, SLE, gout
- History of polyneuropathy, cervical radiculopathy, brachial plexopathy
- Injection for the carpal tunnel in the last 1 month
- History of severe trauma, fracture, operation to both upper extremities at any time
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 |
|---|---|---|
| high-intensity laser therapyHILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given. | Device | A hot laser derived from a Nd: YAG laser, sham high-intensity laser therapy |
| sham high-intensity laser therapyHILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions. | Device | A hot laser derived from a Nd: YAG laser, sham high-intensity laser therapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain.
3 secondary outcomes
Boston Carpal Tunnel Questionnaire
Time frame: Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.
Hand Grip Force Measurement Test
Time frame: Baseline- week 2- week 12
The cross-sectional area of the median nerve
Time frame: Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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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.
BANU ORDAHAN principal investigator
Meram Medical School, Necmettin Erbakan University, Konya, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity laser therapy in people with Carpal Tunnel Syndrome, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]). 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 26 Jun 2023.