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

Carpal Tunnel Syndrome Clinical Trial

— KaLi-CTS  

Official title:

The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome: A Randomized, Single-Blinded, Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248541
• Other study ID #: EK-NR:35-255 ex 22/23
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Medical University of Graz
• Contact: Lars-Peter Kamolz, Univ.Prof. MSc.
• Phone: +43 316 385
• Email: lars.kamolz[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• treatment with low-level laser therapy
low-level laser therapy (wavelength of 620 - 640nm)
• treatment with conventional light diodes
conventional light diodes

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: at rest (Numerical Rating Scale for Pain, NRS)	Pain at rest (NRS), scale 0-10, higher score indicates worse pain	baseline, after 3 weeks, after 6 weeks
Primary	Pain:movement pain (Numerical Rating Scale for Pain, NRS)	Pain at activity (NRS), scale 0-10, higher score indicates worse pain	baseline, after 3 weeks, after 6 weeks
Primary	Pain: Night pain (Numerical Rating Scale for Pain, NRS)	Pain over night (NRS), scale 0-10, higher score indicates worse pain	baseline, after 3 weeks, after 6 weeks
Primary	Health-related quality of ife (SF-36 )	Health-related quality of life assessed by SF-36 questionnaire, scores 0-100 for each SF-36 subdomains (out of eight subdomains), higher scores indicates better qualitiy of life	baseline, after 3 weeks, after 6 weeks
Primary	Hand function (Quick-DASH)	Hand function assessed by Quick-DASH (Disabilities of Arm, Shoulder and Hand) questionnaire, 19-95, lower scores indicates better hand function	baseline, after 3 weeks, after 6 weeks
Primary	Hand function and CTS severity (Boston CTS Syndrome Questionnaire)	Hand function and CTS severity assessed by Boston CTS Syndrome Questionnaire (BCTQ)), score range 19 - 95, a higher score indicates lower hand function and more severe CTS symptoms	baseline, after 3 weeks, after 6 weeks
Secondary	Demographic patient data: smoking status	smoking status	1 day (baseline)
Secondary	Demographic patient data: previous illnesses	History of Previous illnesses	1 day (baseline)
Secondary	Medication (painkillers / immunosuppressives)	Medication taken by patients during the study (painkillers: yes/no, immunosuppressives: yes/no)	baseline, after 3 weeks, after 6 weeks
Secondary	Hofmann-Tinel sign (positive / not positive)	Hofmann-Tinel sign (positive / not positive)	baseline, after 3 weeks, after 6 weeks
Secondary	Phalen test (positive / not positive)	Phalen test (positive / not positive)	baseline, after 3 weeks, after 6 weeks
Secondary	2-point discrimination	2-point discrimination test, distance in millimeters	baseline, after 3 weeks, after 6 weeks
Secondary	Sensitivity (Semmes-Weinstein monofilament)	Sensitivity (Semmes-Weinstein monofilament)	baseline, after 3 weeks, after 6 weeks
Secondary	Hand strength / grip strength"	measured with Jamar dynamometer	baseline, after 3 weeks, after 6 weeks
Secondary	Nerve conduction velocity of the median nerve	Nerve conduction velocity of the median nerve (extracted from hospital intern database if available)	baseline