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The project will evaluate the effectiveness of Cryoneurolysis versus radiofrequency procedures in adult patients who are resistant to traditional treatment for knee pain. They are a drug-free pain management procedure.
The main approach to OA management is pain control. Cryoneurolysis versus radiofrequency in decreasing knee pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I will be treated with Cryoneurolysis | Experimental | Cryoneurolysis freezes nerves |
|
| Group II will be treated with pulsed radiofrequency (RF) | Experimental | radiofrequency (RF) uses electric pulses |
|
| Group III will be treated with cooled radiofrequency (RF) | Experimental | uses cooled radiofrequency energy to deactivate pain-causing nerves |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoneurolysis | Device | Cryoneurolysis freezes nerves |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual analogue scale after intervention | Decrement (clinical improvement) in visual analogue scale (VAS) immediately after intervention. The participant's knee discomfort was measured using a VAS. Participants were asked to score their level of pain on a 100-mm horizontal line, ranging from 0 to 100. | immediately after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aliaa Mamdouh Abdelaziz Farag, MD | Contact | +201069468486 | aliaa.mamdouh@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Tanta University | Recruiting | Tanta | Egypt |
Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Results will be published by the investigators in academic journal.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
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This is a prospective, randomised study. The closed envelop randomization method will be used for the randomization of the patients who will be also blinded to group allocation.
| pulsed radiofrequency (RF) |
| Device |
radiofrequency (RF) uses electric pulses |
|
| cooled radiofrequency | Device | uses cooled radiofrequency energy to deactivate pain-causing nerves |
|
| D012216 |
| Rheumatic Diseases |
| D012046 | Rehabilitation |