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

Sponsor
Abant Izzet Baysal University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05589805
Collaborator
(none)
90
3
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Extracorporeal shock wave therapy
  • Device: Laser therapy
  • Other: Control group
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effectiveness of Low-intensity Laser and ESWT Treatments in Carpal Tunnel Syndrome
Anticipated Study Start Date :
Oct 30, 2022
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ESWT group

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.

Device: Extracorporeal shock wave therapy
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.

Experimental: Laser group

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.

Device: Laser therapy
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.

Active Comparator: Control group

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

Other: Control group
Patients will only be given a wrist splint to keep the wrist in neutral position.

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale [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.

  2. Visual Analog Scale [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.

  3. Boston Scale [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.

  4. Boston Scale [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.

  5. Median nerve area measurement [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.

  6. Median nerve area measurement [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.

  7. LANNS neuropathic pain scale [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.

  8. LANNS neuropathic pain scale [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.

Secondary Outcome Measures

  1. Visual Analog Scale (paresteshia) [Baseline]

    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.

  2. Visual Analog Scale (paresteshia) [Post-treatment (3th week)]

    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.

  3. Ouick Dash Score [Baseline]

    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.

  4. Ouick Dash Score [Post-treatment (3th week)]

    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.

Other Outcome Measures

  1. Hand Grip Force [Baseline]

    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.

  2. Hand Grip Force [Post-treatment (3th week)]

    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.

  3. Finger Grip Force [baseline]

    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.

  4. Finger Grip Force [Post-treatment (3th week)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Abant Izzet Baysal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif yaksi, Medical Doctor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier:
NCT05589805
Other Study ID Numbers:
  • AIBU-FTR-EY-07
First Posted:
Oct 21, 2022
Last Update Posted:
Oct 21, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif yaksi, Medical Doctor, Abant Izzet Baysal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2022