Osteo Arthritis KneeNCT03224637
Radiofrequency Neurotomy In Relieving Chronic Knee Pain
A study testing radiofrequency, Paracetamol (conventional) and Ketorolac Tromethamine (conventional) 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 70 years
- Conditions the study is for
- Osteo Arthritis Knee, Pain, Chronic
- What is being tested?
- radiofrequency, Paracetamol (conventional) and Ketorolac Tromethamine (conventional)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2014to Feb 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic arthritis according to the American College of Rheumatology criteria
- diagnosed radiologically patients in stage 3 and 4, according to the Kellgren-Lawrence classification
Who cannot join
- other causes of pain such as radiculopathy, neurological disorders, or intermittent claudication.
- patients receive intraarticular steroid or hyaluronic acids during previous three months.
- patients did previous knee surgery.
- Patients with general contraindication to the application of invasive intervention such as hemorrhage, coagulation disorder, systemic infection or local infection.
- patients with other connective tissue disease affecting the knee. And 6-psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis : A Single-blind Randomized Controlled 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.
Read the detailed description
Osteoarthritis (OA) is commonest chronic arthritis affecting patients usually aged above 45 years. OA decreased health-related quality of life and increased economic costs. Radiofrequency (RF), was used for the treatment of chronic pain unresponsive to conservative therapies. 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, Paracetamol (conventional), Ketorolac Tromethamine (conventional)
- 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 done in the three genicular nerves upper medial and upper lateral and lower medial
Paracetamol (conventional)Drug
Ketorolac Tromethamine (conventional)Drug
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency group | Active comparator | radiofrequency was done in the three genicular nerves upper medial and upper lateral and lower medial Receives: Procedure: radiofrequency |
| conventional group | Active comparator | the patients received conventional paracetamol and non steroidal antiinflammatory Receives: Drug: Paracetamol (conventional); Drug: Ketorolac Tromethamine (conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment by VAS scale
assessing pain by VAS scale
Measured: 6 months
Secondary outcomes (2)
patient satisfaction by Likert scale
Likert scale to assess patients satisfaction
Measured: 6 months
patient disability by Western Ontario McMaster Universities OA index
Western Ontario McMaster Universities OA index to assess disability
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startJul 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 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
- NCT03224637
- Sponsor's protocol ID
- IRB00009913
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El-Hakeim EH, Elawamy A, Kamel EZ, Goma SH, Gamal RM, Ghandour AM, Osman AM, Morsy KM. Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial. Pain Physician. 2018 Mar;21(2):169-177.
PubMed 29565947
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis : A Single-blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03224637
- Acronym / sponsor ID
- IRB00009913
- Conditions
- Osteo Arthritis Knee, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Jul 2017 (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.
Detailed description
Osteoarthritis (OA) is commonest chronic arthritis affecting patients usually aged above 45 years. OA decreased health-related quality of life and increased economic costs. Radiofrequency (RF), was used for the treatment of chronic pain unresponsive to conservative therapies. 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 (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency group | Active comparator | Procedure: radiofrequencyradiofrequency was done in the three genicular nerves upper medial and upper lateral and lower medial |
| conventional group | Active comparator | Drug: Paracetamol (conventional), Drug: Ketorolac Tromethamine (conventional)the patients received conventional paracetamol and non steroidal antiinflammatory |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic arthritis according to the American College of Rheumatology criteria
- diagnosed radiologically patients in stage 3 and 4, according to the Kellgren-Lawrence classification
Key exclusion criteria (5 listed)
- other causes of pain such as radiculopathy, neurological disorders, or intermittent claudication.
- patients receive intraarticular steroid or hyaluronic acids during previous three months.
- patients did previous knee surgery.
- Patients with general contraindication to the application of invasive intervention such as hemorrhage, coagulation disorder, systemic infection or local infection.
- patients with other connective tissue disease affecting the knee. And 6-psychiatric disorders.
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 done in the three genicular nerves upper medial and upper lateral and lower medial | Procedure or surgery | radiofrequency group |
| Paracetamol (conventional) | Drug | conventional group |
| Ketorolac Tromethamine (conventional) | Drug | conventional group |
Primary outcome
pain assessment by VAS scale
Time frame: 6 months
assessing pain by VAS scale
2 secondary outcomes
patient satisfaction by Likert scale
Time frame: 6 months
patient disability by Western Ontario McMaster Universities OA index
Time frame: 6 months
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 25 Jul 2017.
- Derived from this study: PubMed 29565947El-Hakeim EH, Elawamy A, Kamel EZ, Goma SH, Gamal RM, Ghandour AM, Osman AM, Morsy KM. Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial. Pain Physician. 2018 Mar;21(2):169-177.
- Individual participant dataSharing planned: Undecided
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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, Paracetamol (conventional) and Ketorolac Tromethamine (conventional) 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 2 inclusion and 5 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 25 Jul 2017. 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 assessment by VAS scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224637, which also lists 1 linked publication.
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 25 Jul 2017.