Carpal Tunnel SyndromeKaLi-CTSNCT06248541
The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome
A study testing treatment with low-level laser therapy and treatment with conventional light diodes in people with Carpal Tunnel Syndrome, run by Medical University of Graz at 1 site in Austria.
Trial summary
Carpal tunnel syndrome (CTS) is a chronic compression of the median nerve, which can lead to symptoms such as nocturnal pain and paresthesia in the area innervated by the median nerve. The affected patients also describe discomfort and hypoesthesia in the nerve supply area. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- treatment with low-level laser therapy and treatment with conventional light diodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 3 Aug 2023to 31 Dec 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Existing written consent of the participating person after informed consent.
- The patient is capable of giving consent.
- Isolated surgery-induced CTS
- CTS patients with pain (NRS between 2 and 6) and/or paresthesia and/or nocturnal pain that has been present for at least 3 months (pain reported using the "Numerical Rating Scale for Pain" (NRS) between 0 and 10).
- Compliance with 3 weeks of cold light therapy.
Who cannot join
- Absence of informed consent
- Patients under 18 years or over 80 years
- Patients from protected groups as well as people who are not able to personally give consent
- Participation in other clinical trials within the last 4 weeks before the start of the study
- traumatic and atraumatic median nerve lesions/damage/narrowing
- Previous operations in the area innervated by the median nerve or in the area of the affected upper extremity/hand
Show all 15Show fewer
- CTS recurrence of the affected hand
- Thenar atrophy of the affected hand
- Nerve diseases that affect the upper extremity including the hand (e.g. polyneuropathy)
- Cervical radiculopathy C6/C
- Osteoarthritis of the affected hand (e.g. rhizarthrosis)
- Arthritis of the affected hand
- Metabolic diseases that have an influence on the sensory or function of the hand
- Vascular diseases affecting the upper extremity or hand (e.g. Raynaud's syndrome)
- other compressions or injuries of the median nerve (e.g. thoracic outlet syndrome, scalene syndrome, pronator teres syndrome)
Trial locations and contacts
1 site in 1 country.
Andrzej Hecker, MSc. Dr. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University Graz
Graz, Styria, 8010
Andrzej Hecker, MSc. Dr., +43 316 385 81621, andrzej.hecker@medunigraz.at
About this study
Official title: The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome: A Randomized, Single-Blinded, Placebo-Controlled Trial
Carpal tunnel syndrome (CTS) is a chronic compression of the median nerve, which can lead to symptoms such as nocturnal pain and paresthesia in the area innervated by the median nerve. The affected patients also describe discomfort and hypoesthesia in the nerve supply area. Due to the COVID (Coronavirus disease) pandemic, CTS operations have been postponed and delayed. A promising and safe alternative for improving CTS-related symptoms appears to be non-invasive, non-thermal low-level-laser therapy. As a possible conservative, alternative method, low-level-laser therapy has the potential to enable patients with CTS to improve their disease-related symptoms or at least to alleviate the symptoms until the indicated CTS operation (carpal tunnel release).
The aim of this randomized, single-blind, placebo-controlled clinical trial is to investigate the influence of 3 weeks of low-level-laser therapy on the symptoms typical of CTS in patients with surgery-indicated carpal tunnel syndrome and its influence on quality of life.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- treatment with low-level laser therapy, treatment with conventional light diodes
- Keywords
- CTS
- 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.
treatment with low-level laser therapyDevice
low-level laser therapy (wavelength of 620 - 640nm)
treatment with conventional light diodesDevice
conventional light diodes
| Study group | Role | What they receive |
|---|---|---|
| Group 1: treatment with low-level laser therapy | Experimental | Patient gets treated with a low-level laser (wavelength of 620 - 640nm) two times a day for 3 weeks. Receives: Device: treatment with low-level laser therapy |
| Group 2: treatment with conventional light diodes | Placebo comparator | Patient gets treated with conventional light diodes two times a day for 3 weeks. Receives: Device: treatment with conventional light diodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: at rest (Numerical Rating Scale for Pain, NRS)
Pain at rest (NRS), scale 0-10, higher score indicates worse pain
Measured: baseline, after 3 weeks, after 6 weeks
Pain:movement pain (Numerical Rating Scale for Pain, NRS)
Pain at activity (NRS), scale 0-10, higher score indicates worse pain
Measured: baseline, after 3 weeks, after 6 weeks
Pain: Night pain (Numerical Rating Scale for Pain, NRS)
Pain over night (NRS), scale 0-10, higher score indicates worse pain
Measured: baseline, after 3 weeks, after 6 weeks
Health-related quality of ife (SF-36 )
Health-related quality of life assessed by SF-36 questionnaire, scores 0-100 for each SF-36 subdomains (out of eight subdomains), higher scores indicates better qualitiy of life
Measured: baseline, after 3 weeks, after 6 weeks
Hand function (Quick-DASH)
Hand function assessed by Quick-DASH (Disabilities of Arm, Shoulder and Hand) questionnaire, 19-95, lower scores indicates better hand function
Measured: baseline, after 3 weeks, after 6 weeks
Hand function and CTS severity (Boston CTS Syndrome Questionnaire)
Hand function and CTS severity assessed by Boston CTS Syndrome Questionnaire (BCTQ)), score range 19 - 95, a higher score indicates lower hand function and more severe CTS symptoms
Measured: baseline, after 3 weeks, after 6 weeks
Secondary outcomes (9)
Demographic patient data: smoking status
smoking status
Measured: 1 day (baseline)
Demographic patient data: previous illnesses
History of Previous illnesses
Measured: 1 day (baseline)
Medication (painkillers / immunosuppressives)
Medication taken by patients during the study (painkillers: yes/no, immunosuppressives: yes/no)
Measured: baseline, after 3 weeks, after 6 weeks
Hofmann-Tinel sign (positive / not positive)
Hofmann-Tinel sign (positive / not positive)
Measured: baseline, after 3 weeks, after 6 weeks
Phalen test (positive / not positive)
Phalen test (positive / not positive)
Measured: baseline, after 3 weeks, after 6 weeks
2-point discrimination
2-point discrimination test, distance in millimeters
Measured: baseline, after 3 weeks, after 6 weeks
Sensitivity (Semmes-Weinstein monofilament)
Sensitivity (Semmes-Weinstein monofilament)
Measured: baseline, after 3 weeks, after 6 weeks
Hand strength / grip strength"
measured with Jamar dynamometer
Measured: baseline, after 3 weeks, after 6 weeks
Nerve conduction velocity of the median nerve
Nerve conduction velocity of the median nerve (extracted from hospital intern database if available)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start3 Aug 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Medical University of GrazThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrzej Hecker, MSc. Dr., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248541
- Sponsor's protocol ID
- EK-NR:35-255 ex 22/23
- Acronym
- KaLi-CTS
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2024
- Last updated
- 8 Feb 2024
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome: A Randomized, Single-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06248541
- Acronym / sponsor ID
- KaLi-CTS / EK-NR:35-255 ex 22/23
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- CTS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2024 (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.
Carpal tunnel syndrome (CTS) is a chronic compression of the median nerve, which can lead to symptoms such as nocturnal pain and paresthesia in the area innervated by the median nerve. The affected patients also describe discomfort and hypoesthesia in the nerve supply area. Due to the COVID (Coronavirus disease) pandemic, CTS operations have been postponed and delayed. A promising and safe alternative for improving CTS-related symptoms appears to be non-invasive, non-thermal low-level-laser therapy. As a possible conservative, alternative method, low-level-laser therapy has the potential to enable patients with CTS to improve their disease-related symptoms or at least to alleviate the symptoms until the indicated CTS operation (carpal tunnel release).
The aim of this randomized, single-blind, placebo-controlled clinical trial is to investigate the influence of 3 weeks of low-level-laser therapy on the symptoms typical of CTS in patients with surgery-indicated carpal tunnel syndrome and its influence on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: treatment with low-level laser therapy | Experimental | Device: treatment with low-level laser therapyPatient gets treated with a low-level laser (wavelength of 620 - 640nm) two times a day for 3 weeks. |
| Group 2: treatment with conventional light diodes | Placebo comparator | Device: treatment with conventional light diodesPatient gets treated with conventional light diodes two times a day for 3 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Existing written consent of the participating person after informed consent.
- The patient is capable of giving consent.
- Isolated surgery-induced CTS
- CTS patients with pain (NRS between 2 and 6) and/or paresthesia and/or nocturnal pain that has been present for at least 3 months (pain reported using the "Numerical Rating Scale for Pain" (NRS) between 0 and 10).
- Compliance with 3 weeks of cold light therapy.
Key exclusion criteria (15 listed)
- Absence of informed consent
- Patients under 18 years or over 80 years
- Patients from protected groups as well as people who are not able to personally give consent
- Participation in other clinical trials within the last 4 weeks before the start of the study
- traumatic and atraumatic median nerve lesions/damage/narrowing
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 |
|---|---|---|
| treatment with low-level laser therapylow-level laser therapy (wavelength of 620 - 640nm) | Device | Group 1: treatment with low-level laser therapy |
| treatment with conventional light diodesconventional light diodes | Device | Group 2: treatment with conventional light diodes |
Primary outcome
Pain: at rest (Numerical Rating Scale for Pain, NRS)
Time frame: baseline, after 3 weeks, after 6 weeks
Pain at rest (NRS), scale 0-10, higher score indicates worse pain
Pain:movement pain (Numerical Rating Scale for Pain, NRS)
Time frame: baseline, after 3 weeks, after 6 weeks
Pain at activity (NRS), scale 0-10, higher score indicates worse pain
Pain: Night pain (Numerical Rating Scale for Pain, NRS)
Time frame: baseline, after 3 weeks, after 6 weeks
Pain over night (NRS), scale 0-10, higher score indicates worse pain
Health-related quality of ife (SF-36 )
Time frame: baseline, after 3 weeks, after 6 weeks
Health-related quality of life assessed by SF-36 questionnaire, scores 0-100 for each SF-36 subdomains (out of eight subdomains), higher scores indicates better qualitiy of life
Hand function (Quick-DASH)
Time frame: baseline, after 3 weeks, after 6 weeks
Hand function assessed by Quick-DASH (Disabilities of Arm, Shoulder and Hand) questionnaire, 19-95, lower scores indicates better hand function
Hand function and CTS severity (Boston CTS Syndrome Questionnaire)
Time frame: baseline, after 3 weeks, after 6 weeks
Hand function and CTS severity assessed by Boston CTS Syndrome Questionnaire (BCTQ)), score range 19 - 95, a higher score indicates lower hand function and more severe CTS symptoms
9 secondary outcomes
Demographic patient data: smoking status
Time frame: 1 day (baseline)
Demographic patient data: previous illnesses
Time frame: 1 day (baseline)
Medication (painkillers / immunosuppressives)
Time frame: baseline, after 3 weeks, after 6 weeks
Hofmann-Tinel sign (positive / not positive)
Time frame: baseline, after 3 weeks, after 6 weeks
Phalen test (positive / not positive)
Time frame: baseline, after 3 weeks, after 6 weeks
2-point discrimination
Time frame: baseline, after 3 weeks, after 6 weeks
Sensitivity (Semmes-Weinstein monofilament)
Time frame: baseline, after 3 weeks, after 6 weeks
Hand strength / grip strength"
Time frame: baseline, after 3 weeks, after 6 weeks
Nerve conduction velocity of the median nerve
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
Andrzej Hecker, MSc. Dr. contact
Andrzej Hecker, MSc. Dr. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with low-level laser therapy and treatment with conventional light diodes in people with Carpal Tunnel Syndrome, run by Medical University of Graz at 1 site in Austria.
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 5 inclusion and 15 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 8 Feb 2024. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars-Peter Kamolz, Univ.Prof. MSc. (+43 316 385 ext. 81621, lars.kamolz@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: at rest (Numerical Rating Scale for Pain, NRS) (time frame: baseline, after 3 weeks, after 6 weeks). The study lists 6 primary outcomes in all. 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 8 Feb 2024.