Evaluation of the Efficacy of Low Level Laser Therapy in Ulnar Neuropathy at the Elbow

NCT ID: NCT06086210

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-10-01

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.

Conditions

Ulnar Nerve Entrapment at Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low-level laser therapy group

Low-level laser therapy was applied to the patients with the elbow at 45° flexion, creating a total of 5 areas by drawing 2 cm intervals 4 cm below the elbow and 6 cm above the elbow. The patients in the group used the elbow rest splint throughout the night during the treatment.

Group Type: ACTIVE_COMPARATOR

Low-level laser therapy

Intervention Type: OTHER

Low-level laser therapy was applied to each area for 1 minute, with a wavelength of 808 nm and a dose of 2j/cm2 for a total of 5 minutes,10j/cm2 in continuous mode. A total of 15 sessions were applied 5 days a week for 3 weeks.

Sham group

Sham group was applied with a laser probe by the elbow in 45° flexion, creating a total of 5 areas by drawing 2 cm intervals 4 cm below the elbow and 6 cm above the elbow. The patients in the group used the elbow rest splint throughout the night during the treatment.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

Sham therapy was applied to each area for 1 minute, with a wavelength of 0 nm and a dose of 0j/cm2 for a total of 5 minutes, 0j/cm2. A total of 15 sessions were applied 5 days a week for 3 weeks.

Interventions

Low-level laser therapy

Low-level laser therapy was applied to each area for 1 minute, with a wavelength of 808 nm and a dose of 2j/cm2 for a total of 5 minutes,10j/cm2 in continuous mode. A total of 15 sessions were applied 5 days a week for 3 weeks.

Intervention Type: OTHER

Sham

Sham therapy was applied to each area for 1 minute, with a wavelength of 0 nm and a dose of 0j/cm2 for a total of 5 minutes, 0j/cm2. A total of 15 sessions were applied 5 days a week for 3 weeks.

Intervention Type: OTHER

Other Intervention Names

Medical Italia PR999 4W

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulsah Celik

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gulsah Celik

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gülşah Çelik, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

Antalya Training and Research Hospital

Antalya, Muratpaşa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AntalyaTRHCelik01

Identifier Type: -

Identifier Source: org_study_id