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

Primary Purpose

Ulnar Nerve Entrapment at Elbow

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low-level laser therapy
Sham
Sponsored by
Gulsah Celik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulnar Nerve Entrapment at Elbow focused on measuring Low-lever laser therapy, Splint, Ulnar Nerve Entrapment at Elbow, Electroneuromyography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Antalya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Low-level laser therapy group

Sham group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
Electrophysiological Studies
In the electrophysiological evaluation, motor nerve conduction velocity in meter/second of the ulnar nerve at the elbow was measured.
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.
Electrophysiological Studies
In the electrophysiological evaluation sensory nerve conduction velocity in meter/second at the wrist was measured.
Electrophysiological Studies
In the electrophysiological evaluation sensory distal latency in millisecond recorded at the wrist and was measured.

Full Information

First Posted
October 7, 2023
Last Updated
October 13, 2023
Sponsor
Gulsah Celik
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1. Study Identification

Unique Protocol Identification Number
NCT06086210
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gulsah Celik

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Nerve Entrapment at Elbow
Keywords
Low-lever laser therapy, Splint, Ulnar Nerve Entrapment at Elbow, Electroneuromyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups with laser treatment and sham-controlled treatment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-level laser therapy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low-level laser therapy
Other Intervention Name(s)
Medical Italia PR999 4W
Intervention Description
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
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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).
Time Frame
Baseline, Days 15 and Months 3
Secondary Outcome Measure Information:
Title
Hand Grip Strength
Description
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.
Time Frame
Baseline, Days 15 and Months 3
Title
Provocative Tests
Description
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.
Time Frame
Baseline, Days 15 and Months 3
Title
QuickDASH score
Description
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.
Time Frame
Baseline, Days 15 and Months 3
Title
Electrophysiological Studies
Description
In the electrophysiological evaluation, motor nerve conduction velocity in meter/second of the ulnar nerve at the elbow was measured.
Time Frame
Baseline, Days 15 and Months 3
Title
Electrophysiological Studies
Description
In the electrophysiological evaluation ulnar distal latency in millisecond difference at distances measured by the centimeter method (inching) at the elbow was measured.
Time Frame
Baseline, Days 15 and Months 3
Title
Electrophysiological Studies
Description
In the electrophysiological evaluation sensory nerve conduction velocity in meter/second at the wrist was measured.
Time Frame
Baseline, Days 15 and Months 3
Title
Electrophysiological Studies
Description
In the electrophysiological evaluation sensory distal latency in millisecond recorded at the wrist and was measured.
Time Frame
Baseline, Days 15 and Months 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülşah Çelik, MD
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital
City
Antalya
State/Province
Muratpaşa
ZIP/Postal Code
55400
Country
Turkey

12. IPD Sharing Statement

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

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