Knee OsteoarthritisNCT03613610
Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique
A study testing Radio-frequency ablation of genicular nerves in people with Knee Osteoarthritis, run by Alaa Fouli Gaber Ebrahim at 1 site in Egypt.
Trial summary
The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome: 1. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Radio-frequency ablation of genicular nerves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2018to Nov 2018
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).
Who cannot join
- 1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.
- 5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Needles Approach... A New Technique of Genicular Nerve Radio-frequency Ablation for Pain Relief in Advanced Knee Osteoarthritis
The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome:
- Pain intensity via the visual analogue score (VAS).
- Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure
Secondary outcome:
- Failure rate.
- Incidence of any complication.
- Total analgesic requirement during the period of follow up.
- Conditions
- Knee Osteoarthritis
- Being tested
- Radio-frequency ablation of genicular nerves
- Keywords
- Genicular nerve radio-frequency ablation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-frequency ablation of genicular nervesRadiation
Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Three needles group | Active comparator | Not described Receives: Radiation: Radio-frequency ablation of genicular nerves |
| Single needle group | Active comparator | Not described Receives: Radiation: Radio-frequency ablation of genicular nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
Pain intensity via the visual analogue score (VAS).
Measured: 6 months after the procedure
Oxford knee score
Follow up of pain and function via the Oxford knee score
Measured: 6 months after the procedure
Secondary outcomes (2)
Failure rate
Persistence of pain after the procedure
Measured: 6 months after the procedure
Incidence of complication
Any infection, heamatoma
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start26 Feb 2018
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Fouli Gaber Ebrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Fouli Gaber Ebrahim, Minia University
- Investigators
- Omyma Sh Mohamed, Ass. prof., Study director, Minia UniversityAnd El raheem Ma Mohamed, Lecturer, Study chair, Assist universitySarah Mo Omar, Lecturer, Study chair, Minia UniversityAlaa Fo Gaber, Resident, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613610
- Sponsor's protocol ID
- 60-2/2018
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Needles Approach... A New Technique of Genicular Nerve Radio-frequency Ablation for Pain Relief in Advanced Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03613610
- Acronym / sponsor ID
- 60-2/2018
- Conditions
- Knee Osteoarthritis
- Keywords
- Genicular nerve radio-frequency ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alaa Fouli Gaber EbrahimUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 3 Aug 2018 (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 study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome:
- Pain intensity via the visual analogue score (VAS).
- Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure
Secondary outcome:
- Failure rate.
- Incidence of any complication.
- Total analgesic requirement during the period of follow up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three needles group | Active comparator | Radiation: Radio-frequency ablation of genicular nerves |
| Single needle group | Active comparator | Radiation: Radio-frequency ablation of genicular nerves |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).
Key exclusion criteria (2 listed)
- 1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.
- 5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-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 |
|---|---|---|
| Radio-frequency ablation of genicular nervesAblation of the genicular nerves for pain relief in advanced knee osteoarthritis | Radiation | Single needle group, Three needles group |
Primary outcome
Visual analogue score
Time frame: 6 months after the procedure
Pain intensity via the visual analogue score (VAS).
Oxford knee score
Time frame: 6 months after the procedure
Follow up of pain and function via the Oxford knee score
2 secondary outcomes
Failure rate
Time frame: 6 months after the procedure
Incidence of complication
Time frame: 6 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Omyma Sh Mohamed, Ass. prof. study director
Minia University
And El raheem Ma Mohamed, Lecturer study chair
Assist university
Sarah Mo Omar, Lecturer study chair
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio-frequency ablation of genicular nerves in people with Knee Osteoarthritis, run by Alaa Fouli Gaber Ebrahim 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: status not confirmed, as of the sponsor's last update on 3 Aug 2018. 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?
Results are not available in the source record.
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 analogue score (time frame: 6 months after the procedure). 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 3 Aug 2018.