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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Extracorporeal shock wave therapy; Device: Laser therapy; Other: Control group

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Post-treatment (3th week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Post-treatment (3th week)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Grip Force	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.	Baseline
Hand Grip Force	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.	Post-treatment (3th week)
Finger Grip Force	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.	baseline
Finger Grip Force	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.	Post-treatment (3th week)

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2022
• Primary Completion (Anticipated): October 20, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: extracorporeal shock wave therapy; carpal tunnel syndrome; laser treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: AIBU-FTR-EY-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No