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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
low-level laser therapy (wavelength of 620 - 640nm)
conventional light diodes
Medical University Graz
Graz, Styria, Austria
RECRUITINGPain: at rest (Numerical Rating Scale for Pain, NRS)
Pain at rest (NRS), scale 0-10, higher score indicates worse pain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, after 3 weeks, after 6 weeks
Demographic patient data: smoking status
smoking status
Time frame: 1 day (baseline)
Demographic patient data: previous illnesses
History of Previous illnesses
Time frame: 1 day (baseline)
Medication (painkillers / immunosuppressives)
Medication taken by patients during the study (painkillers: yes/no, immunosuppressives: yes/no)
Time frame: baseline, after 3 weeks, after 6 weeks
Hofmann-Tinel sign (positive / not positive)
Hofmann-Tinel sign (positive / not positive)
Time frame: baseline, after 3 weeks, after 6 weeks
Phalen test (positive / not positive)
Phalen test (positive / not positive)
Time frame: baseline, after 3 weeks, after 6 weeks
2-point discrimination
2-point discrimination test, distance in millimeters
Time frame: baseline, after 3 weeks, after 6 weeks
Sensitivity (Semmes-Weinstein monofilament)
Sensitivity (Semmes-Weinstein monofilament)
Time frame: baseline, after 3 weeks, after 6 weeks
Hand strength / grip strength"
measured with Jamar dynamometer
Time frame: 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)
Time frame: baseline
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