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

NCT05589805 | Unknown

• 1 other identifier: AIBU-FTR-EY-07
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; extracorporeal shock wave therapy; laser treatment

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Visual Analog Scale (paresteshia)

  Baseline

• Visual Analog Scale (paresteshia)

  Post-treatment (3th week)

• Ouick Dash Score

  Baseline

• Ouick Dash Score

  Post-treatment (3th week)

Other Outcomes (4)

• Hand Grip Force

  Baseline

• Hand Grip Force

  Post-treatment (3th week)

• Finger Grip Force

  baseline

Study Arms (3)

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.

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.

Device: Laser therapy

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

Extracorporeal shock wave therapy DEVICE

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.

ESWT group

Laser therapy DEVICE

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.

Laser group

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy; Laser Therapy; Control Groups

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ablation Techniques; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: October 30, 2022
• Primary Completion: October 20, 2023
• Study Completion: October 30, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10