Clinical trial NCT06248541: The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome
Official title: The Effect of Low-Level Laser Therapy in Carpal Tunnel Syndrome: A Randomized, Single-Blinded, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: CTS
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Pain: at rest (Numerical Rating Scale for Pain, NRS)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Pain:movement pain (Numerical Rating Scale for Pain, NRS)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Pain: Night pain (Numerical Rating Scale for Pain, NRS)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Health-related quality of ife (SF-36 )
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Hand function (Quick-DASH)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Hand function and CTS severity (Boston CTS Syndrome Questionnaire)
timeFrame: baseline, after 3 weeks, after 6 weeks
Secondary outcomes:
measure: Demographic patient data: smoking status
timeFrame: 1 day (baseline)
measure: Demographic patient data: previous illnesses
timeFrame: 1 day (baseline)
measure: Medication (painkillers / immunosuppressives)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Hofmann-Tinel sign (positive / not positive)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Phalen test (positive / not positive)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: 2-point discrimination
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Sensitivity (Semmes-Weinstein monofilament)
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Hand strength / grip strength"
timeFrame: baseline, after 3 weeks, after 6 weeks
measure: Nerve conduction velocity of the median nerve
timeFrame: baseline
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Andrzej Hecker, MSc. Dr.
role: PRINCIPAL_INVESTIGATOR
References: