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

NCT06248541 | Unknown

• 1 other identifier: EK-NR:35-255 ex 22/23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

CTS

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Demographic patient data: smoking status

  1 day (baseline)

• Demographic patient data: previous illnesses

  1 day (baseline)

• Medication (painkillers / immunosuppressives)

  baseline, after 3 weeks, after 6 weeks

• Hofmann-Tinel sign (positive / not positive)

  baseline, after 3 weeks, after 6 weeks

• Phalen test (positive / not positive)

  baseline, after 3 weeks, after 6 weeks

Study Arms (2)

Group 1: treatment with low-level laser therapy

EXPERIMENTAL

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

Group 2: treatment with conventional light diodes

PLACEBO COMPARATOR

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

Device: treatment with conventional light diodes

Interventions

treatment with low-level laser therapy DEVICE

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

Group 1: treatment with low-level laser therapy

treatment with conventional light diodes DEVICE

conventional light diodes

Group 2: treatment with conventional light diodes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Therapeutics; Low-Level Light Therapy

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)

Laser Therapy; Phototherapy

Study Officials

• Andrzej Hecker, MSc. Dr.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars-Peter Kamolz, Univ.Prof. MSc.

CONTACT

+43 316 385; lars.kamolz@medunigraz.at

Andrzej Hecker, MSc. Dr.

CONTACT

andrzej.hecker@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 8, 2024
• Study Start: August 3, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

AU (1)