Osteoarthritis Knees BothOsteoarthritisNCT03891680
Intra Articular Botox Injection in Treatment of Osteoarthritis
A study testing Botox Injectable Product and Radiofrequancy in people with Osteoarthritis Knees Both, run by Assiut University at 1 site in Egypt.
Trial summary
Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Osteoarthritis Knees Both
- What is being tested?
- Botox Injectable Product and Radiofrequancy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2019to 1 May 2020
- 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
Who cannot join
- coagulopathy Organ failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis
Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided
Read the detailed description
Compared the short and long term effects of sonography guided intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided
- Conditions
- Osteoarthritis Knees Both
- Being tested
- Botox Injectable Product, Radiofrequancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox Injectable ProductDrug
Intra articular Botox injection
RadiofrequancyDevice
Genicular nerves radiofrequancy
| Study group | Role | What they receive |
|---|---|---|
| Botox injection | Experimental | Not described Receives: Drug: Botox Injectable Product |
| Genicular Radio frequency | Active comparator | Not described Receives: Device: Radiofrequancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analog scale
0-10 Visual analog scale( less than 3 no pain 3-5 in pain, more than 5 sever pain
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 posted27 Mar 2019
- Study start20 Oct 2019
- Primary completion30 Mar 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Knees BothStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
- Investigators
- Abdallah Allam, Study chair, Physical medicine Tanta universityRasha Gaber, Study chair, Biochemistry Tanta universityKe Vin, Study chair, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891680
- Sponsor's protocol ID
- Botox in osteoarthritis
- Acronym
- Osteoarthritis
- Status last verified
- Dec 2022
- First submitted
- 23 Mar 2019
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03891680
- Acronym / sponsor ID
- Osteoarthritis / Botox in osteoarthritis
- Conditions
- Osteoarthritis Knees Both
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 27 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.
Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided
Detailed description
Compared the short and long term effects of sonography guided intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox injection | Experimental | Drug: Botox Injectable Product |
| Genicular Radio frequency | Active comparator | Device: Radiofrequancy |
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
Key exclusion criteria (1 listed)
- coagulopathy Organ failure
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 |
|---|---|---|
| Botox Injectable ProductIntra articular Botox injection | Drug | Botox injection |
| RadiofrequancyGenicular nerves radiofrequancy | Device | Genicular Radio frequency |
Primary outcome
Pain visual analog scale
Time frame: 6 months
0-10 Visual analog scale( less than 3 no pain 3-5 in pain, more than 5 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 29 Dec 2022.
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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.
Abdallah Allam study chair
Physical medicine Tanta university
Rasha Gaber study chair
Biochemistry Tanta university
Ke Vin study chair
Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox Injectable Product and Radiofrequancy in people with Osteoarthritis Knees Both, 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 1 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 29 Dec 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.
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: 6 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 29 Dec 2022.