The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome

NCT ID: NCT06248541

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2025-12-31

Brief Summary

Carpal tunnel syndrome (CTS) is a chronic compression of the median nerve, which can lead to symptoms such as nocturnal pain and paresthesia in the area innervated by the median nerve. The affected patients also describe discomfort and hypoesthesia in the nerve supply area. Due to the COVID (Coronavirus disease) pandemic, CTS operations have been postponed and delayed. A promising and safe alternative for improving CTS-related symptoms appears to be non-invasive, non-thermal low-level-laser therapy. As a possible conservative, alternative method, low-level-laser therapy has the potential to enable patients with CTS to improve their disease-related symptoms or at least to alleviate the symptoms until the indicated CTS operation (carpal tunnel release).

The aim of this randomized, single-blind, placebo-controlled clinical trial is to investigate the influence of 3 weeks of low-level-laser therapy on the symptoms typical of CTS in patients with surgery-indicated carpal tunnel syndrome and its influence on quality of life.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1: treatment with low-level laser therapy

Patient gets treated with a low-level laser (wavelength of 620 - 640nm) two times a day for 3 weeks.

Group Type: EXPERIMENTAL

treatment with low-level laser therapy

Intervention Type: DEVICE

low-level laser therapy (wavelength of 620 - 640nm)

Group 2: treatment with conventional light diodes

Patient gets treated with conventional light diodes two times a day for 3 weeks.

Group Type: PLACEBO_COMPARATOR

treatment with conventional light diodes

Intervention Type: DEVICE

conventional light diodes

Interventions

treatment with low-level laser therapy

low-level laser therapy (wavelength of 620 - 640nm)

Intervention Type: DEVICE

treatment with conventional light diodes

conventional light diodes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Existing written consent of the participating person after informed consent.
• The patient is capable of giving consent.
• Isolated surgery-induced CTS
• CTS patients with pain (NRS between 2 and 6) and/or paresthesia and/or nocturnal pain that has been present for at least 3 months (pain reported using the "Numerical Rating Scale for Pain" (NRS) between 0 and 10).
• Compliance with 3 weeks of cold light therapy.

Exclusion Criteria

• Absence of informed consent
• Patients under 18 years or over 80 years
• Patients from protected groups as well as people who are not able to personally give consent
• Participation in other clinical trials within the last 4 weeks before the start of the study
• traumatic and atraumatic median nerve lesions/damage/narrowing
• Previous operations in the area innervated by the median nerve or in the area of the affected upper extremity/hand
• CTS recurrence of the affected hand
• Thenar atrophy of the affected hand
• Nerve diseases that affect the upper extremity including the hand (e.g. polyneuropathy)
• Cervical radiculopathy C6/C
• Osteoarthritis of the affected hand (e.g. rhizarthrosis)
• Arthritis of the affected hand
• Metabolic diseases that have an influence on the sensory or function of the hand
• Vascular diseases affecting the upper extremity or hand (e.g. Raynaud's syndrome)
• other compressions or injuries of the median nerve (e.g. thoracic outlet syndrome, scalene syndrome, pronator teres syndrome)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrzej Hecker, MSc. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University Graz

Graz, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Lars-Peter Kamolz, Univ.Prof. MSc.

Role: CONTACT

lars.kamolz@medunigraz.at

+43 316 385 ext. 81621

Andrzej Hecker, MSc. Dr.

Role: CONTACT

andrzej.hecker@medunigraz.at

Facility Contacts

Andrzej Hecker, MSc. Dr.

Role: primary

andrzej.hecker@medunigraz.at

+43 316 385 81621

Other Identifiers

EK-NR:35-255 ex 22/23

Identifier Type: -

Identifier Source: org_study_id