Clinical trial NCT06086210: Evaluation of the Efficacy of Low Level Laser Therapy in Ulnar Neuropathy at the Elbow
Official title: Evaluation of the Efficacy of Low Level Laser Therapy in Ulnar Neuropathy at the Elbow in Terms of Symptoms, Clinical and Electrophysiological: A Randomized, Prospective, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulnar Nerve Entrapment at Elbow
Keywords: Low-lever laser therapy
Splint
Ulnar Nerve Entrapment at Elbow
Electroneuromyography
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-17
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with laser treatment and sham-controlled treatment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is, to demonstrate the effectiveness of low-level laser therapy on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

Detailed description: Ulnar neuropathy of the elbow is the second most common entrapment neuropathy of the upper extremity. The ulnar nerve is prone to entrapment due to its anatomical location in the elbow. The most important cause of entrapment occurs as a result of frequent chronic mechanical compression or stretching. Repetitive flexion-extension movement of the elbow increases the pressure in both the cubital tunnel and other potential entrapment sites, causing tension in the ulnar nerve and increased intraneural pressure.

Ulnar neuropathy of the elbow, a detailed history and a comprehensive physical examination are the essential first steps in making the correct diagnosis. In case of doubt, electrophysiological studies, in particular, play an important role in diagnosis by determining both the location of nerve compression and the severity of the disease. There are conservative and surgical methods for the treatment of ulnar neuropathy in the elbow. In most patients, especially in mild and moderate entrapments, conservative treatment is preferred instead of surgery as initial treatment.

Low-level laser therapy, one of the physical therapy modalities, creates photochemical reactions and biostimulation in the cells, interstitial tissue, vascular structure and immune system. Its anti-inflammatory effect is through inhibition of Cyclooxygenase-2 enzyme and a decrease in Prostaglandin E2 levels, and its analgesic effect is by inhibiting nociceptive pathways in peripheral nerves, thus reducing pain. It has been shown to increase nerve regeneration and nerve conduction, reduce the effects of nerve compression, and may stimulate nerve healing thanks to its biophysical effect.

There is no sham-controlled study showing the effectiveness of low-level laser therapy in elbow ulnar neuropathy, the second most common entrapment neuropathy. The study was planned to investigate the effectiveness of low-level laser treatment on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

Eligibility criteria: Inclusion Criteria:

* Ulnar neuropathy at the elbow evidenced by electrophysiological evaluation
* Symptoms onset with more than 1 months

Exclusion Criteria:

* Presence of thenar, hypothenar or intrinsic muscle atrophy,
* Diabetes mellitus
* Hypothyroidism
* Receiving an electrophysiological diagnosis of carpal tunnel syndrome, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome
* Vascular disease
* Ulnar nerve injury or trauma,
* Malignancy,
* Having received treatment for ulnar neuropathy in the elbow within the last 3 months,
* Using nonsteroidal anti-inflammatory drugs (NSAI) regularly

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline, Days 15 and Months 3
Secondary outcomes:
measure: Hand Grip Strength
timeFrame: Baseline, Days 15 and Months 3
measure: Provocative Tests
timeFrame: Baseline, Days 15 and Months 3
measure: QuickDASH score
timeFrame: Baseline, Days 15 and Months 3
measure: Electrophysiological Studies
timeFrame: Baseline, Days 15 and Months 3
measure: Electrophysiological Studies
timeFrame: Baseline, Days 15 and Months 3
measure: Electrophysiological Studies
timeFrame: Baseline, Days 15 and Months 3
measure: Electrophysiological Studies
timeFrame: Baseline, Days 15 and Months 3
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
state: Muratpaşa
Study officials:
affiliation: Antalya Training and Research Hospital
name: Gülşah Çelik, MD
role: PRINCIPAL_INVESTIGATOR
References: