Carpal Tunnel SyndromeNCT05589805
Comparison of Low-intensity Laser and ESWT in Carpal Tunnel Syndrome
A study testing Extracorporeal shock wave therapy and Laser therapy in people with Carpal Tunnel Syndrome, run by Abant Izzet Baysal University.
Trial summary
Carpal tunnel syndrome is the most common neuropathy of the median nerve. Conservative methods are used in mild and moderate CTS in the treatment. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Extracorporeal shock wave therapy and Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2022to 30 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years
- Having a clinic compatible with carpal tunnel syndrome,
- Patients with electrophysiological data compatible with mild and moderate carpal tunnel syndrome
Who cannot join
- Cervical radiculopathy , polyneuropathy , brachial plexopathy , thoracic outlet syndrome
- Regular use of oral steroids or nsaii in the last 3 months
- Systemic disease (DM, hypothyroidism, RA, gout, acromegaly, CKD, dialysis)
- Severe carpal tunnel syndrome (kts)
About this study
Official title: Comparison of the Effectiveness of Low-intensity Laser and ESWT Treatments in Carpal Tunnel Syndrome
Carpal tunnel syndrome is the most common neuropathy of the median nerve. Conservative methods are used in mild and moderate CTS in the treatment. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.
Read the detailed description
Carpal tunnel syndrome is the most common neuropathy of the median nerve. Its incidence increases between the ages of 40-60. Its prevalence is 4-5%, and incidence is 2.7%. It is more common in women than men. The vast majority of cases are idiopathic.The first symptoms usually start at night. The patient wakes up with a feeling of swelling without any visible swelling and symptoms such as burning, numbness and tingling in the median nerve region.In severe cases, hand weakness and thenar atrophy develop. Provocative tests such as phalen, reverse phalen, tinel, carpal compression test, tourniquet test can be used in the examination.The diagnosis of carpal tunnel syndrome is made by nerve conduction studies and electromyography. Conservative methods are used in mild and moderate CTS in the treatment. Surgical methods are recommended in severe cases and in cases unresponsive to conservative treatment.One of the methods used in the treatment is Laser (Light Amplification by Stimulated Emission of Radiation).There are low and high intensity laser applications according to their energy densities. The basic mechanism of action is tissue stimulation. ESWT (Extracorporeal Shock Wave Therapy), another treatment method, shows therapeutic properties by focusing high-amplitude sound waves on the desired area of the body. Apart from the mechanical effect, it also has an effect at the cellular level.In previous studies, both low-intensity laser and ESWT application were found to be effective in the treatment of carpal tunnel syndrome. However, as far as we know, there is no study comparing the efficacy of low-intensity laser therapy and ESWT therapy in carpal tunnel syndrome. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Extracorporeal shock wave therapy, Laser therapy, Control group
- Keywords
- carpal tunnel syndrome, extracorporeal shock wave therapy, laser treatment
- 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.
Extracorporeal shock wave therapyDevice
In addition to wrist splint, ESWT treatment (1.5 bar, 5Hz, 1000 beats) will be applied to the patients with Elmed Vibrolith Ortho brand ESWT device, which we routinely use in the treatment of carpal tunnel syndrome, for 3 weeks, once a week.
Laser therapyDevice
In addition to the wrist splint, the patients will be treated with the BTL-4110 Laser Topline model low-intensity laser device, which we routinely use in the treatment of carpal tunnel syndrome in our hospital, 5 days a week for 15 sessions of laser treatment.
Control groupOther
Patients will only be given a wrist splint to keep the wrist in neutral position.
| Study group | Role | What they receive |
|---|---|---|
| ESWT group | Experimental | In addition to wrist splint, ESWT treatment (1.5 bar, 5Hz, 1000 beats) will be applied to the patients with the Elmed Vibrolith Ortho brand ESWT device, which we routinely use in the treatment of carpal tunnel syndrome, for 3 weeks, once a week. Receives: Device: Extracorporeal shock wave therapy |
| Laser group | Experimental | In addition to the wrist splint, the patients will be treated with the BTL-4110 Laser Topline model low-intensity laser device, which we routinely use in the treatment of carpal tunnel syndrome in our hospital, 5 days a week for 15 sessions of laser treatment. Receives: Device: Laser therapy |
| Control group | Active comparator | Patients will only be given a wrist splint to keep the wrist in neutral position. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a 10 cm line on the horizontal plane where the patient evaluates the pain. There are lines from 0 to 10. 0 means no pain, and 10 means very severe pain. After this information is given to the patient, the patient will mark the pain they feel within 1 week.
Measured: Baseline
Visual Analog Scale
It is a 10 cm line on the horizontal plane where the patient evaluates the pain. There are lines from 0 to 10. 0 means no pain, and 10 means very severe pain. After this information is given to the patient, the patient will mark the pain they feel within 1 week.
Measured: Post-treatment (3th week)
Boston Scale
The Boston Questionnaire was developed by Levine et al. in 1993. It consists of two parts, the symptom severity scale and the functional capacity scale.Boston Symptom Severity Scale consists of 11 questions. Symptoms such as pain, numbness, weakness, tingling are questioned. Symptoms are scored using a 5-answer scale between "absent and very severe". In the scoring of 11-55, a high score is interpreted as increased symptom severity.
Boston Functional Capacity Scale consists of 8 questions. It questions the degree of difficulty of activities of daily living, and each question has five different answers with a score between 1 and 5. The average score is obtained by dividing the total score by the number of questions. Results are scored between 8-40 and high values are interpreted as impaired hand functionality.
Measured: Baseline
Boston Scale
The Boston Questionnaire was developed by Levine et al. in 1993. It consists of two parts, the symptom severity scale and the functional capacity scale.Boston Symptom Severity Scale consists of 11 questions. Symptoms such as pain, numbness, weakness, tingling are questioned. Symptoms are scored using a 5-answer scale between "absent and very severe". In the scoring of 11-55, a high score is interpreted as increased symptom severity.
Boston Functional Capacity Scale consists of 8 questions. It questions the degree of difficulty of activities of daily living, and each question has five different answers with a score between 1 and 5. The average score is obtained by dividing the total score by the number of questions. Results are scored between 8-40 and high values are interpreted as impaired hand functionality.
Measured: Post-treatment (3th week)
Median nerve area measurement
It will be measured from the distal finger line by manually surrounding the nerve just below the hyperechoic line surrounding the median nerve with the ultrasound device.
Measured: Baseline
Median nerve area measurement
It will be measured from the distal finger line by manually surrounding the nerve just below the hyperechoic line surrounding the median nerve with the ultrasound device.
Measured: Post-treatment (3th week)
LANNS neuropathic pain scale
It is used to distinguish between neuropathic pain and nociceptive pain. It consists of 2 parts. The first part is filled by the patient. In the department, the physician tests whether allodynia is present. A score above 12 is classified as neuropathic pain.
Measured: Baseline
LANNS neuropathic pain scale
It is used to distinguish between neuropathic pain and nociceptive pain. It consists of 2 parts. The first part is filled by the patient. In the department, the physician tests whether allodynia is present. A score above 12 is classified as neuropathic pain.
Measured: Post-treatment (3th week)
Secondary outcomes (4)
Visual Analog Scale (paresteshia)
t is a 10 cm line on the horizontal plane where the patient evaluates the pain. There are lines from 0 to 10. 0 means no pain, and 10 means very severe pain. After this information is given to the patient, the patient will mark the paresteshia they feel within 1 week.
Measured: Baseline
Visual Analog Scale (paresteshia)
t is a 10 cm line on the horizontal plane where the patient evaluates the pain. There are lines from 0 to 10. 0 means no pain, and 10 means very severe pain. After this information is given to the patient, the patient will mark the paresteshia they feel within 1 week.
Measured: Post-treatment (3th week)
Ouick Dash Score
There are 11 items in total in this questionnaire. It is evaluated between 1-5 points according to the increasing degree of symptoms or difficulty. At least 10 of the questions must be answered in order for the Quick DASH score to be calculated. The result of the calculation is evaluated between 0 and 100.0 is interpreted as no difficulty and no symptoms, 100 as no activity or severe symptoms.
Measured: Baseline
Ouick Dash Score
There are 11 items in total in this questionnaire. It is evaluated between 1-5 points according to the increasing degree of symptoms or difficulty. At least 10 of the questions must be answered in order for the Quick DASH score to be calculated. The result of the calculation is evaluated between 0 and 100.0 is interpreted as no difficulty and no symptoms, 100 as no activity or severe symptoms.
Measured: Post-treatment (3th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start30 Oct 2022 (estimated)
- Primary completion20 Oct 2023 (estimated)
- Study completion30 Oct 2023 (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 Abant Izzet Baysal 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif yaksi, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589805
- Sponsor's protocol ID
- AIBU-FTR-EY-07
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Low-intensity Laser and ESWT Treatments in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05589805
- Acronym / sponsor ID
- AIBU-FTR-EY-07
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, extracorporeal shock wave therapy, laser treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 21 Oct 2022 (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 is the most common neuropathy of the median nerve. Conservative methods are used in mild and moderate CTS in the treatment. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.
Detailed description
Carpal tunnel syndrome is the most common neuropathy of the median nerve. Its incidence increases between the ages of 40-60. Its prevalence is 4-5%, and incidence is 2.7%. It is more common in women than men. The vast majority of cases are idiopathic.The first symptoms usually start at night. The patient wakes up with a feeling of swelling without any visible swelling and symptoms such as burning, numbness and tingling in the median nerve region.In severe cases, hand weakness and thenar atrophy develop. Provocative tests such as phalen, reverse phalen, tinel, carpal compression test, tourniquet test can be used in the examination.The diagnosis of carpal tunnel syndrome is made by nerve conduction studies and electromyography. Conservative methods are used in mild and moderate CTS in the treatment. Surgical methods are recommended in severe cases and in cases unresponsive to conservative treatment.One of the methods used in the treatment is Laser (Light Amplification by Stimulated Emission of Radiation).There are low and high intensity laser applications according to their energy densities. The basic mechanism of action is tissue stimulation. ESWT (Extracorporeal Shock Wave Therapy), another treatment method, shows therapeutic properties by focusing high-amplitude sound waves on the desired area of the body. Apart from the mechanical effect, it also has an effect at the cellular level.In previous studies, both low-intensity laser and ESWT application were found to be effective in the treatment of carpal tunnel syndrome. However, as far as we know, there is no study comparing the efficacy of low-intensity laser therapy and ESWT therapy in carpal tunnel syndrome. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESWT group | Experimental | Device: Extracorporeal shock wave therapyIn addition to wrist splint, ESWT treatment (1.5 bar, 5Hz, 1000 beats) will be applied to the patients with the Elmed Vibrolith Ortho brand ESWT device, which we routinely use in the treatment of carpal tunnel syndrome, for 3 weeks, once a week. |
| Laser group | Experimental | Device: Laser therapyIn addition to the wrist splint, the patients will be treated with the BTL-4110 Laser Topline model low-intensity laser device, which we routinely use in the treatment of carpal tunnel syndrome in our hospital, 5 days a week for 15 sessions of laser treatment. |
| Control group | Active comparator | Other: Control groupPatients will only be given a wrist splint to keep the wrist in neutral position. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years
- Having a clinic compatible with carpal tunnel syndrome,
- Patients with electrophysiological data compatible with mild and moderate carpal tunnel syndrome
Key exclusion criteria (4 listed)
- Cervical radiculopathy , polyneuropathy , brachial plexopathy , thoracic outlet syndrome
- Regular use of oral steroids or nsaii in the last 3 months
- Systemic disease (DM, hypothyroidism, RA, gout, acromegaly, CKD, dialysis)
- Severe carpal tunnel syndrome (kts)
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 |
|---|---|---|
| Extracorporeal shock wave therapyIn addition to wrist splint, ESWT treatment (1.5 bar, 5Hz, 1000 beats) will be applied to the patients with Elmed Vibrolith Ortho brand ESWT device, which we routinely use in the treatment of carpal tunnel syndrome, for 3 weeks, once a week. | Device | ESWT group |
| Laser therapyIn addition to the wrist splint, the patients will be treated with the BTL-4110 Laser Topline model low-intensity laser device, which we routinely use in the treatment of carpal tunnel syndrome in our hospital, 5 days a week for 15 sessions of laser treatment. | Device | Laser group |
| Control groupPatients will only be given a wrist splint to keep the wrist in neutral position. | Other | Control group |
Primary outcome
Visual Analog Scale
Time frame: Baseline
It is a 10 cm line on the horizontal plane where the patient evaluates the pain. There are lines from 0 to 10. 0 means no pain, and 10 means very severe pain. After this information is given to the patient, the patient will mark the pain they feel within 1 week.
Visual Analog Scale
Time frame: Post-treatment (3th week)
It is a 10 cm line on the horizontal plane where the patient evaluates the pain. There are lines from 0 to 10. 0 means no pain, and 10 means very severe pain. After this information is given to the patient, the patient will mark the pain they feel within 1 week.
Boston Scale
Time frame: Baseline
The Boston Questionnaire was developed by Levine et al. in 1993. It consists of two parts, the symptom severity scale and the functional capacity scale.Boston Symptom Severity Scale consists of 11 questions. Symptoms such as pain, numbness, weakness, tingling are questioned. Symptoms are scored using a 5-answer scale between "absent and very severe". In the scoring of 11-55, a high score is interpreted as increased symptom severity. Boston Functional Capacity Scale consists of 8 questions. It questions the degree of difficulty of activities of daily living, and each question has five different answers with a score between 1 and 5. The average score is obtained by dividing the total score by the number of questions. Results are scored between 8-40 and high values are interpreted as impaired hand functionality.
Boston Scale
Time frame: Post-treatment (3th week)
The Boston Questionnaire was developed by Levine et al. in 1993. It consists of two parts, the symptom severity scale and the functional capacity scale.Boston Symptom Severity Scale consists of 11 questions. Symptoms such as pain, numbness, weakness, tingling are questioned. Symptoms are scored using a 5-answer scale between "absent and very severe". In the scoring of 11-55, a high score is interpreted as increased symptom severity. Boston Functional Capacity Scale consists of 8 questions. It questions the degree of difficulty of activities of daily living, and each question has five different answers with a score between 1 and 5. The average score is obtained by dividing the total score by the number of questions. Results are scored between 8-40 and high values are interpreted as impaired hand functionality.
Median nerve area measurement
Time frame: Baseline
It will be measured from the distal finger line by manually surrounding the nerve just below the hyperechoic line surrounding the median nerve with the ultrasound device.
Median nerve area measurement
Time frame: Post-treatment (3th week)
It will be measured from the distal finger line by manually surrounding the nerve just below the hyperechoic line surrounding the median nerve with the ultrasound device.
LANNS neuropathic pain scale
Time frame: Baseline
It is used to distinguish between neuropathic pain and nociceptive pain. It consists of 2 parts. The first part is filled by the patient. In the department, the physician tests whether allodynia is present. A score above 12 is classified as neuropathic pain.
LANNS neuropathic pain scale
Time frame: Post-treatment (3th week)
It is used to distinguish between neuropathic pain and nociceptive pain. It consists of 2 parts. The first part is filled by the patient. In the department, the physician tests whether allodynia is present. A score above 12 is classified as neuropathic pain.
4 secondary outcomes
Visual Analog Scale (paresteshia)
Time frame: Baseline
Visual Analog Scale (paresteshia)
Time frame: Post-treatment (3th week)
Ouick Dash Score
Time frame: Baseline
Ouick Dash Score
Time frame: Post-treatment (3th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy and Laser therapy in people with Carpal Tunnel Syndrome, run by Abant Izzet Baysal University.
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 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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 (time frame: Baseline). The study lists 8 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 21 Oct 2022.