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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: treatment with low-level laser therapy; Device: treatment with conventional light diodes

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars-Peter Kamolz, Univ.Prof. MSc.; Phone Number: 81621 +43 316 385; Email: lars.kamolz@medunigraz.at
• Study Contact Backup: Name: Andrzej Hecker, MSc. Dr.; Email: andrzej.hecker@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Recruiting
      • Medical University Graz
      • Contact: Andrzej Hecker, MSc. Dr.; Phone Number: +43 316 385 81621; Email: andrzej.hecker@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: treatment with low-level laser therapy; low-level laser therapy (wavelength of 620 - 640nm)
Placebo Comparator: Group 2: treatment with conventional light diodes; Patient gets treated with conventional light diodes two times a day for 3 weeks.	Device: treatment with conventional light diodes; conventional light diodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic patient data: smoking status	smoking status	1 day (baseline)
Demographic patient data: previous illnesses	History of Previous illnesses	1 day (baseline)
Medication (painkillers / immunosuppressives)	Medication taken by patients during the study (painkillers: yes/no, immunosuppressives: yes/no)	baseline, after 3 weeks, after 6 weeks
Hofmann-Tinel sign (positive / not positive)	Hofmann-Tinel sign (positive / not positive)	baseline, after 3 weeks, after 6 weeks
Phalen test (positive / not positive)	Phalen test (positive / not positive)	baseline, after 3 weeks, after 6 weeks
2-point discrimination	2-point discrimination test, distance in millimeters	baseline, after 3 weeks, after 6 weeks
Sensitivity (Semmes-Weinstein monofilament)	Sensitivity (Semmes-Weinstein monofilament)	baseline, after 3 weeks, after 6 weeks
Hand strength / grip strength"	measured with Jamar dynamometer	baseline, after 3 weeks, after 6 weeks
Nerve conduction velocity of the median nerve	Nerve conduction velocity of the median nerve (extracted from hospital intern database if available)	baseline

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Andrzej Hecker, MSc. Dr., Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: CTS
• 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: EK-NR:35-255 ex 22/23

Drug and device information, study documents

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