Osteo Arthritis KneeNCT03886142
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis
A study testing radiofrequency and platelet rich plasma injection in people with Osteo Arthritis Knee and Pain, Chronic, run by Assiut University at 1 site in Egypt.
Trial summary
Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee, Pain, Chronic
- What is being tested?
- radiofrequency and platelet rich plasma injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Sep 2018to 30 Nov 2019
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis knee
Who cannot join
- coaguloapthy
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Genicular Nerve Radiofrequency Ablation Versus Intra-Articular Platelet Rich Plasma in Chronic Knee Osteoarthritis; a Randomized Clinical Trial
Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.
- Conditions
- Osteo Arthritis Knee, Pain, Chronic
- Being tested
- radiofrequency, platelet rich plasma injection
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequencyProcedure or surgery
radiofrequency of the genicular nerves
platelet rich plasma injectionProcedure or surgery
intra articular injection of platelet rich plasma
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency | Active comparator | genicular nerves pulsed radiofrequency Receives: Procedure: radiofrequency |
| intra-articular platelet rich plasma | Active comparator | injection of platelet rich plasma in the affected joint Receives: Procedure: platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain visual analog scale
assessment of visual analog scale (VAS) VAS of zero means no pain, and 10 means sever pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start27 Sep 2018
- Primary completion30 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients with chronic knee osteoarthritis non res ponders to conventional medical treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886142
- Sponsor's protocol ID
- IRB00009923
- Status last verified
- Jan 2020
- First submitted
- 20 Mar 2019
- Last updated
- 18 Jan 2020
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Genicular Nerve Radiofrequency Ablation Versus Intra-Articular Platelet Rich Plasma in Chronic Knee Osteoarthritis; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03886142
- Acronym / sponsor ID
- IRB00009923
- Conditions
- Osteo Arthritis Knee, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 22 Mar 2019 (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.
Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- patients with chronic knee osteoarthritis non res ponders to conventional medical treatment
| Arm | Type | Receives |
|---|---|---|
| radiofrequency | Active comparator | Procedure: radiofrequencygenicular nerves pulsed radiofrequency |
| intra-articular platelet rich plasma | Active comparator | Procedure: platelet rich plasma injectioninjection of platelet rich plasma in the affected joint |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- osteoarthritis knee
Key exclusion criteria (2 listed)
- coaguloapthy
- patient refusal
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 |
|---|---|---|
| radiofrequencyradiofrequency of the genicular nerves | Procedure or surgery | radiofrequency |
| platelet rich plasma injectionintra articular injection of platelet rich plasma | Procedure or surgery | intra-articular platelet rich plasma |
Primary outcome
pain visual analog scale
Time frame: 12 months
assessment of visual analog scale (VAS) VAS of zero means no pain, and 10 means sever pain
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 18 Jan 2020.
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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 study testing radiofrequency and platelet rich plasma injection in people with Osteo Arthritis Knee and Pain, Chronic, run by Assiut 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 2 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 18 Jan 2020. 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.
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?
pain visual analog scale (time frame: 12 months). 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 18 Jan 2020.