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

NCT06086210 | Completed

• 1 other identifier: AntalyaTRHCelik01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulnar Nerve Entrapment at Elbow

Keywords

Low-lever laser therapy; Splint; Ulnar Nerve Entrapment at Elbow; Electroneuromyography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Hand Grip Strength

  Baseline, Days 15 and Months 3

• Provocative Tests

  Baseline, Days 15 and Months 3

• QuickDASH score

  Baseline, Days 15 and Months 3

• Electrophysiological Studies

  Baseline, Days 15 and Months 3

• Electrophysiological Studies

  Baseline, Days 15 and Months 3

Study Arms (2)

Low-level laser therapy group

ACTIVE COMPARATOR

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.

Other: Low-level laser therapy

Sham group

SHAM COMPARATOR

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.

Other: Sham

Interventions

Low-level laser therapy 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.

Also known as: Medical Italia PR999 4W

Low-level laser therapy group

Sham 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.

Sham group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulsah Celik: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Muratpaşa, 55400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Interventions

Low-Level Light Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Gülşah Çelik, MD

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Since the light coming from the probe was visible in the laser applications used in both groups, the patients were not able to learn which group they were in, meaning they were blinded. All outcome measures were evaluated by another researcher who did not know which group the patients were in, thus ensuring that the study was double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups with laser treatment and sham-controlled treatment

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 17, 2023
• Study Start: October 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

TU (1)