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Comparison of Low-intensity Laser and ESWT in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
Laser therapy
Control group
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, extracorporeal shock wave therapy, laser treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years
  • Having a clinic compatible with carpal tunnel syndrome,
  • Patients with electrophysiological data compatible with mild and moderate carpal tunnel syndrome

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    ESWT group

    Laser group

    Control group

    Arm Description

    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.

    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.

    Patients will only be given a wrist splint to keep the wrist in neutral position.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    October 18, 2022
    Last Updated
    October 18, 2022
    Sponsor
    Abant Izzet Baysal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05589805
    Brief Title
    Comparison of Low-intensity Laser and ESWT in Carpal Tunnel Syndrome
    Official Title
    Comparison of the Effectiveness of Low-intensity Laser and ESWT Treatments in Carpal Tunnel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2022 (Anticipated)
    Primary Completion Date
    October 20, 2023 (Anticipated)
    Study Completion Date
    October 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Abant Izzet Baysal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome
    Keywords
    carpal tunnel syndrome, extracorporeal shock wave therapy, laser treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESWT group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Laser group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients will only be given a wrist splint to keep the wrist in neutral position.
    Intervention Type
    Device
    Intervention Name(s)
    Extracorporeal shock wave therapy
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Laser therapy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Intervention Description
    Patients will only be given a wrist splint to keep the wrist in neutral position.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale
    Description
    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.
    Time Frame
    Baseline
    Title
    Visual Analog Scale
    Description
    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.
    Time Frame
    Post-treatment (3th week)
    Title
    Boston Scale
    Description
    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.
    Time Frame
    Baseline
    Title
    Boston Scale
    Description
    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.
    Time Frame
    Post-treatment (3th week)
    Title
    Median nerve area measurement
    Description
    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.
    Time Frame
    Baseline
    Title
    Median nerve area measurement
    Description
    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.
    Time Frame
    Post-treatment (3th week)
    Title
    LANNS neuropathic pain scale
    Description
    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.
    Time Frame
    Baseline
    Title
    LANNS neuropathic pain scale
    Description
    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.
    Time Frame
    Post-treatment (3th week)
    Secondary Outcome Measure Information:
    Title
    Visual Analog Scale (paresteshia)
    Description
    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.
    Time Frame
    Baseline
    Title
    Visual Analog Scale (paresteshia)
    Description
    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.
    Time Frame
    Post-treatment (3th week)
    Title
    Ouick Dash Score
    Description
    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.
    Time Frame
    Baseline
    Title
    Ouick Dash Score
    Description
    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.
    Time Frame
    Post-treatment (3th week)
    Other Pre-specified Outcome Measures:
    Title
    Hand Grip Force
    Description
    North Coast brand hydraulic hand dynamometer will be used. According to the standard position recommended by the American Association of Hand Therapists; Measurements are made when the patient is sitting upright, the knee angle is 90°, the shoulder is in adduction and neutral rotation, the elbow is in 90° flexion, the forearm is in midrotation, and the wrist is in neutral. 3 measurements are made, with a one-minute break between each measurement. The test result is taken as the average of the three measurements in kilograms.
    Time Frame
    Baseline
    Title
    Hand Grip Force
    Description
    North Coast brand hydraulic hand dynamometer will be used. According to the standard position recommended by the American Association of Hand Therapists; Measurements are made when the patient is sitting upright, the knee angle is 90°, the shoulder is in adduction and neutral rotation, the elbow is in 90° flexion, the forearm is in midrotation, and the wrist is in neutral. 3 measurements are made, with a one-minute break between each measurement. The test result is taken as the average of the three measurements in kilograms.
    Time Frame
    Post-treatment (3th week)
    Title
    Finger Grip Force
    Description
    North Coast brand hydraulic pinchmeter will be used for finger grip strength measurement. It is evaluated in two different positions as atheral and pinch (triple) grip.
    Time Frame
    baseline
    Title
    Finger Grip Force
    Description
    North Coast brand hydraulic pinchmeter will be used for finger grip strength measurement. It is evaluated in two different positions as atheral and pinch (triple) grip.
    Time Frame
    Post-treatment (3th week)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-65 years Having a clinic compatible with carpal tunnel syndrome, Patients with electrophysiological data compatible with mild and moderate carpal tunnel syndrome Exclusion Criteria: 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)

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Low-intensity Laser and ESWT in Carpal Tunnel Syndrome

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