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

Ulnar Nerve Entrapment at Elbow Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06086210
• Other study ID #: AntalyaTRHCelik01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Nerve Compression Syndromes
• Ulnar Nerve Entrapment at Elbow
• Ulnar Neuropathies

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya	Muratpasa

Sponsors (1)

Lead Sponsor	Collaborator
Gulsah Celik

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	The patient's symptoms were filled in, with the VAS score increasing from 0 to 10. The end of a 10 cm line with 0 cm indicating no complaints (best) and the end with 10 cm indicating very severe complaints (worst).	Baseline, Days 15 and Months 3
Secondary	Hand Grip Strength	The hand is squeezed to grasp with maximum force, with the shoulder in adduction and neutral rotation, the elbow in 90° flexion, the forearm in midrotation and the wrist in neutral. Jamar hand dynamometer was used in measurements. Three measurements were written in kilograms (kg), with a one-minute rest between each measurement, and the average value was recorded.	Baseline, Days 15 and Months 3
Secondary	Provocative Tests	Tinel's test involves tapping the ulnar nerve in the medial epicondylar groove. In the elbow flexion test, the elbow is held in maximum flexion, the forearm is in supination, and the wrist is in full extension for 60 seconds. In the ulnar nerve compression test, the elbow is kept in 20° flexion and the forearm is kept in supination position. The examiner places his index and middle fingers over the cubital tunnel and applies pressure for 60 seconds. In all of these tests, if paresthesia or numbness occurs in the ulnar nerve distribution, the test is considered positive.	Baseline, Days 15 and Months 3
Secondary	QuickDASH score	Quick-DASH score, which quickly evaluates arm-shoulder-hand problems, consists of 11 questions. Functional evaluation of the patients' upper extremities and strains during daily living activities are questioned. The best score in total is determined as 0, and the lowest score is determined as 100.	Baseline, Days 15 and Months 3
Secondary	Electrophysiological Studies	In the electrophysiological evaluation, motor nerve conduction velocity in meter/second of the ulnar nerve at the elbow was measured.	Baseline, Days 15 and Months 3
Secondary	Electrophysiological Studies	In the electrophysiological evaluation ulnar distal latency in millisecond difference at distances measured by the centimeter method (inching) at the elbow was measured.	Baseline, Days 15 and Months 3
Secondary	Electrophysiological Studies	In the electrophysiological evaluation sensory nerve conduction velocity in meter/second at the wrist was measured.	Baseline, Days 15 and Months 3
Secondary	Electrophysiological Studies	In the electrophysiological evaluation sensory distal latency in millisecond recorded at the wrist and was measured.	Baseline, Days 15 and Months 3