Ulnar Nerve Entrapment at ElbowNCT06086210
Evaluation of the Efficacy of Low Level Laser Therapy in Ulnar Neuropathy at the Elbow
A study testing Low-level laser therapy in people with Ulnar Nerve Entrapment at Elbow, run by Gulsah Celik at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulnar Nerve Entrapment at Elbow
- What is being tested?
- Low-level laser therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ulnar neuropathy at the elbow evidenced by electrophysiological evaluation
- Symptoms onset with more than 1 months
Who cannot join
- 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,
Show all 9Show fewer
- Malignancy,
- Having received treatment for ulnar neuropathy in the elbow within the last 3 months,
- Using nonsteroidal anti-inflammatory drugs (NSAI) regularly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Muratpaşa, 55400
About this study
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
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.
Read the 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
- Being tested
- Low-level laser therapy, Sham
- Keywords
- Low-lever laser therapy, Splint, Ulnar Nerve Entrapment at Elbow, Electroneuromyography
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyOther
Also called Medical Italia PR999 4W
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.
ShamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Days 15 and Months 3
Secondary outcomes (7)
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.
Measured: Baseline, Days 15 and Months 3
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.
Measured: Baseline, Days 15 and Months 3
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.
Measured: Baseline, Days 15 and Months 3
Electrophysiological Studies
In the electrophysiological evaluation, motor nerve conduction velocity in meter/second of the ulnar nerve at the elbow was measured.
Measured: Baseline, Days 15 and Months 3
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.
Measured: Baseline, Days 15 and Months 3
Electrophysiological Studies
In the electrophysiological evaluation sensory nerve conduction velocity in meter/second at the wrist was measured.
Measured: Baseline, Days 15 and Months 3
Electrophysiological Studies
In the electrophysiological evaluation sensory distal latency in millisecond recorded at the wrist and was measured.
Measured: Baseline, Days 15 and Months 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Oct 2022
- Primary completion1 May 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar Nerve Entrapment at ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with laser treatment and sham-controlled treatment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsah Celik
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gulsah Celik, Antalya Training and Research Hospital
- Investigators
- Gülşah Çelik, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086210
- Sponsor's protocol ID
- AntalyaTRHCelik01
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06086210
- Acronym / sponsor ID
- AntalyaTRHCelik01
- Conditions
- Ulnar Nerve Entrapment at Elbow
- Keywords
- Low-lever laser therapy, Splint, Ulnar Nerve Entrapment at Elbow, Electroneuromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Gulsah CelikOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with laser treatment and sham-controlled treatment
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy group | Active comparator | Other: Low-level laser therapyLow-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 | Sham comparator | Other: ShamSham 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ulnar neuropathy at the elbow evidenced by electrophysiological evaluation
- Symptoms onset with more than 1 months
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level laser therapyAlso: Medical Italia PR999 4WLow-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. | Other | Low-level laser therapy group |
| ShamSham 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. | Other | Sham group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, Days 15 and Months 3
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).
7 secondary outcomes
Hand Grip Strength
Time frame: Baseline, Days 15 and Months 3
Provocative Tests
Time frame: Baseline, Days 15 and Months 3
QuickDASH score
Time frame: Baseline, Days 15 and Months 3
Electrophysiological Studies
Time frame: Baseline, Days 15 and Months 3
Electrophysiological Studies
Time frame: Baseline, Days 15 and Months 3
Electrophysiological Studies
Time frame: Baseline, Days 15 and Months 3
Electrophysiological Studies
Time frame: Baseline, Days 15 and Months 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülşah Çelik, MD principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy in people with Ulnar Nerve Entrapment at Elbow, run by Gulsah Celik at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline, Days 15 and Months 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.