Carpal Tunnel Syndrome
Conditions
Keywords
CTS
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.
Interventions
DEVICEtreatment with low-level laser therapy
low-level laser therapy (wavelength of 620 - 640nm)
DEVICEtreatment with conventional light diodes
conventional light diodes
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Nerve conduction velocity of the median nerve | baseline | Nerve conduction velocity of the median nerve (extracted from hospital intern database if available) |
| Hand strength / grip strength | baseline, after 3 weeks, after 6 weeks | measured with Jamar dynamometer |
| Demographic patient data: previous illnesses | 1 day (baseline) | History of Previous illnesses |
| Medication (painkillers / immunosuppressives) | baseline, after 3 weeks, after 6 weeks | Medication taken by patients during the study (painkillers: yes/no, immunosuppressives: yes/no) |
| Hofmann-Tinel sign (positive / not positive) | baseline, after 3 weeks, after 6 weeks | Hofmann-Tinel sign (positive / not positive) |
| Phalen test (positive / not positive) | baseline, after 3 weeks, after 6 weeks | Phalen test (positive / not positive) |
| 2-point discrimination | baseline, after 3 weeks, after 6 weeks | 2-point discrimination test, distance in millimeters |
Countries
Austria
Contacts
Primary ContactLars-Peter Kamolz, Univ.Prof. MSc.
Backup ContactAndrzej Hecker, MSc. Dr.
Outcome results
None listed