The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome (KaLi-CTS)

Medical University of Graz

Status: Enrolling

Conditions: Carpal Tunnel Syndrome

Treatments: Device: treatment with conventional light diodes; Device: treatment with low-level laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06248541

EK-NR:35-255 ex 22/23

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Group 1: treatment with low-level laser therapy

Experimental group

Description:

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

Treatment:

Device: treatment with low-level laser therapy

Group 2: treatment with conventional light diodes

Placebo Comparator group

Description:

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

Treatment:

Device: treatment with conventional light diodes