The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Device: treatment with low-level laser therapyDevice: treatment with conventional light diodes
- Registration Number
- NCT06248541
- Lead Sponsor
- Medical University of Graz
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: treatment with low-level laser therapy 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 2: treatment with conventional light diodes treatment with conventional light diodes Patient gets treated with conventional light diodes two times a day for 3 weeks.
- Primary Outcome Measures
Name Time Method Pain: at rest (Numerical Rating Scale for Pain, NRS) baseline, after 3 weeks, after 6 weeks Pain at rest (NRS), scale 0-10, higher score indicates worse pain
Hand function (Quick-DASH) baseline, after 3 weeks, after 6 weeks Hand function assessed by Quick-DASH (Disabilities of Arm, Shoulder and Hand) questionnaire, 19-95, lower scores indicates better hand function
Pain: Night pain (Numerical Rating Scale for Pain, NRS) baseline, after 3 weeks, after 6 weeks Pain over night (NRS), scale 0-10, higher score indicates worse pain
Health-related quality of ife (SF-36 ) baseline, after 3 weeks, after 6 weeks 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
Pain:movement pain (Numerical Rating Scale for Pain, NRS) baseline, after 3 weeks, after 6 weeks Pain at activity (NRS), scale 0-10, higher score indicates worse pain
Hand function and CTS severity (Boston CTS Syndrome Questionnaire) baseline, after 3 weeks, after 6 weeks 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
- Secondary Outcome Measures
Name Time Method Medication (painkillers / immunosuppressives) baseline, after 3 weeks, after 6 weeks Medication taken by patients during the study (painkillers: yes/no, immunosuppressives: yes/no)
Sensitivity (Semmes-Weinstein monofilament) baseline, after 3 weeks, after 6 weeks Sensitivity (Semmes-Weinstein monofilament)
Demographic patient data: smoking status 1 day (baseline) smoking status
Hofmann-Tinel sign (positive / not positive) baseline, after 3 weeks, after 6 weeks Hofmann-Tinel sign (positive / not positive)
2-point discrimination baseline, after 3 weeks, after 6 weeks 2-point discrimination test, distance in millimeters
Demographic patient data: previous illnesses 1 day (baseline) History of Previous illnesses
Phalen test (positive / not positive) baseline, after 3 weeks, after 6 weeks Phalen test (positive / not positive)
Hand strength / grip strength" baseline, after 3 weeks, after 6 weeks measured with Jamar dynamometer
Nerve conduction velocity of the median nerve baseline Nerve conduction velocity of the median nerve (extracted from hospital intern database if available)
Trial Locations
- Locations (1)
Medical University Graz
🇦🇹Graz, Styria, Austria