Ulnar Neuropathy at ElbowPhase 2/3NCT05567081
Efficacy of Ultrasound-Guided PRP Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow
A Phase 2/3 study testing Triamcinolone Acetonide 40mg/mL and PRP in people with Ulnar Neuropathy at Elbow, run by Tanta University at 1 site in Egypt.
Trial summary
This study was be performed on 60 patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography selected from Physical medicine, Rheumatology \& Rehabilitation Department, Faculty of Medicine, Tanta University. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ulnar Neuropathy at Elbow
- What is being tested?
- Triamcinolone Acetonide 40mg/mL and PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 11 Jul 2022
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography.
Who cannot join
- Patients with severe ulnar neuropathy at elbow according to Gu's classification. 15
- Brachial plexopathy, peripheral neuropathy, and cervical radiculopathy.
- History of recent elbow trauma or operation.
- Malignant neoplasm.
- Pregnancy.
- Bleeding Disorders.
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- Factors affecting nerve healing process e.g., tobacco use and systemic corticosteroid administration.
- Contraindications for PRP injection:
- Significant renal or hepatic dysfunction.
- Critical thrombocytopenia.
- Hemodynamic instability.
- Septicemia.
- Local infection at the site of the procedure.
- Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks.
- Local injection at the suspected treatment site within the last month.
- Recent fever or illness.
- Hemoglobin level <10 g/dL.
- Platelet dysfunction disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study
This study was be performed on 60 patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography selected from Physical medicine, Rheumatology \& Rehabilitation Department, Faculty of Medicine, Tanta University.
Patients were be randomly divided into 2 groups:
Group I: will undergo a single ultrasound-guided deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve. PRP will be prepared by PRP method.
Group II: will undergo a single ultrasound-guided deep perineural injection with 1ml corticosteroid (triamcinolone acetonide, 40mg/mL) mixed with 1ml lidocaine hydrochloride.
- Conditions
- Ulnar Neuropathy at Elbow
- Being tested
- Triamcinolone Acetonide 40mg/mL, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide 40mg/mLDrug
Also called Epirelefan 40 mg
Deep perineural injection with 1cm corticosteroid mixed with 1ml lidocaine hydrochloride.
PRPDrug
Deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | 3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve. Receives: Drug: PRP |
| Corticosteroid group | Experimental | Triamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve. Receives: Drug: Triamcinolone Acetonide 40mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ultrasound cross sectional area of ulnar nerve at elbow after injection
Measured: 1, and 3 months after injection
Change in nerve conduction parameters of ulnar nerve at elbow after injection
Change in ulnar nerve conduction velocity and CMAP across elbow.
Measured: 1 and 3 months after injection
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jun 2021
- Primary completion21 Apr 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar Neuropathy at ElbowStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajar Anwer Elnagar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567081
- Sponsor's protocol ID
- 34743/6/21
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study
- ClinicalTrials.gov ID
- NCT05567081
- Acronym / sponsor ID
- 34743/6/21
- Conditions
- Ulnar Neuropathy at Elbow
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 5 Oct 2022 (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.
This study was be performed on 60 patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography selected from Physical medicine, Rheumatology \& Rehabilitation Department, Faculty of Medicine, Tanta University.
Patients were be randomly divided into 2 groups:
Group I: will undergo a single ultrasound-guided deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve. PRP will be prepared by PRP method.
Group II: will undergo a single ultrasound-guided deep perineural injection with 1ml corticosteroid (triamcinolone acetonide, 40mg/mL) mixed with 1ml lidocaine hydrochloride.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Drug: PRP3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve. |
| Corticosteroid group | Experimental | Drug: Triamcinolone Acetonide 40mg/mLTriamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography.
Key exclusion criteria (18 listed)
- Patients with severe ulnar neuropathy at elbow according to Gu's classification. 15
- Brachial plexopathy, peripheral neuropathy, and cervical radiculopathy.
- History of recent elbow trauma or operation.
- Malignant neoplasm.
- Pregnancy.
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 |
|---|---|---|
| Triamcinolone Acetonide 40mg/mLAlso: Epirelefan 40 mgDeep perineural injection with 1cm corticosteroid mixed with 1ml lidocaine hydrochloride. | Drug | Corticosteroid group |
| PRPDeep perineural injection with 3ml PRP at the thickest part of the ulnar nerve. | Drug | PRP group |
Primary outcome
Change in ultrasound cross sectional area of ulnar nerve at elbow after injection
Time frame: 1, and 3 months after injection
Change in nerve conduction parameters of ulnar nerve at elbow after injection
Time frame: 1 and 3 months after injection
Change in ulnar nerve conduction velocity and CMAP across elbow.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 month after injection
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 5 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triamcinolone Acetonide 40mg/mL and PRP in people with Ulnar Neuropathy at Elbow, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 18 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 5 Oct 2022. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in ultrasound cross sectional area of ulnar nerve at elbow after injection (time frame: 1, and 3 months after injection). The study lists 2 primary outcomes in all. 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 5 Oct 2022.