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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group 2: treatment with conventional light diodes | Placebo Comparator | Patient gets treated with conventional light diodes two times a day for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment with low-level laser therapy | Device | low-level laser therapy (wavelength of 620 - 640nm) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic patient data: smoking status | smoking status | 1 day (baseline) |
| Demographic patient data: previous illnesses | History of Previous illnesses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars-Peter Kamolz, Univ.Prof. MSc. | Contact | +43 316 385 | 81621 | lars.kamolz@medunigraz.at |
| Andrzej Hecker, MSc. Dr. | Contact | andrzej.hecker@medunigraz.at |
| Name | Affiliation | Role |
|---|---|---|
| Andrzej Hecker, MSc. Dr. | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Recruiting | Graz | Styria | 8010 | Austria |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D010789 | Phototherapy |
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| treatment with conventional light diodes | Device | conventional light diodes |
|
| 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 |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |