- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188561
Comparative Study Between Intra Articular Injection of Hyaluronic Acid (HA) With Platelet Rich Plasma (PRP) Versus Genicular Nerve Thermal Radiation in Management of Pain in Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study the investigators to comparing between the effect of Intra articular injection of hyaluronic acid (HA) with platelet rich plasma (PRP) versus genicular nerve thermal radiation in management of pain in knee osteoarthritis.
Knee assessment and pain score recorded according to Visual Analogue Scale (VAS) after one week, one month, three months, six months following intraarticular injection and radiation.
All analgesics stopped and only (Arcoxia "etoricoxib" 60 mg, 90 mg) was taken after the procedure, total day dose and frequency will be reported, other analgesics taken by the patient is reported also.
Improvement of daily activities and clinical examination for the studied knees is observed.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11451
- Ahmed Abdalla Mohamed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild to moderate Knee osteoarthritis.
- Body mass index: 24 - 42 kg/m2
Exclusion Criteria:
- Coagulopathy.
- Acute local or systemic infections with knee effusion Previous knee surgery (relative Contraindication).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intraarticular injection Group
Patients included in the study had been received 2 ml hyaluronic acid with concentration of 22mg/ml .
Platelet rich plasma is arranged by withdrawing 10 ml of patient's personal venous blood, anticoagulant is added, and centrifuged by duo-spin method, at the rate of 3500 rpm for five minutes then injected twice with 2 weeks interval
|
Patients included in the study had been received 2 ml high molecular weight (1.476 x 106 average Daltons) hyaluronic acid with concentration of 22mg/ml (OPTIVISC UK hyaluronic acid for intra articular injection). Platelet rich plasma is arranged by withdrawing 10 ml of patient's personal venous blood, anticoagulant is added, and centrifuged by duo-spin method, at the rate of 3500 rpm for five minutes then injected twice with 2 weeks interval. 3 distinct layers are produced by the end of the centrifugation: plasma, buffy coat (platelet) and RBCs, about 3 - 3.5 ml of PRP is produced at the end with platelet concentration of 1.4 - 1.6 million/μl on average.
Other Names:
|
ACTIVE_COMPARATOR: Radiofrequency Group
Radiofrequency Generator is a four electrode pain management for interventional pain management procedures.
Patients had been placed in the supine position and their knee will be supported by a small pillow placed beneath the popliteal fossa.
Fluoroscopic images of knee joint had been obtained.
Possible locations of genicular nerves had been determined on the lateral, medial aspects of the lower end of the femoral bone and on the medial aspect of the tibia, under fluoroscopic guidance.
|
Thermal radiation is done by Neurotherm 2000 (Neurotherm NT 2000 Radiofrequency (RF) Generator is a four electrode pain management (RF) generator for interventional pain management procedures.
Neurotherm's newest system offers accurate independent controls of each electrode through the touch screen interface and output control knobs.),
Patients from the radiofrequency (RF) group had been placed in the supine position and their knee will be supported by a small pillow placed beneath the popliteal fossa.
Fluoroscopic images of knee joint had been obtained.
Possible locations of genicular nerves had been determined on the lateral, medial aspects of the lower end of the femoral bone and on the medial aspect of the tibia, under fluoroscopic guidance.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Measurment via Visual analogue score
Time Frame: Measured throuout 6 months follow up session
|
Visual analogue score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
A higher score indicates greater pain intensity was measured throuout 6 months follow up session
|
Measured throuout 6 months follow up session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic requirements Comparison
Time Frame: Throuout 6 months follow up session
|
Compairing between analgesia requirements in Rf group and IAI group
|
Throuout 6 months follow up session
|
Improvement of daily activities between 2 groups
Time Frame: Throuout 6 months follow up session
|
Compairing between analgesia requirements in Rf group and IAI group
|
Throuout 6 months follow up session
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32094/01/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Novartis PharmaceuticalsRecruitingSymptomatic Knee OsteoarthritisUnited States, Spain, Hungary, Argentina, Germany, Slovakia, Czechia, Belgium, Romania
-
University of BathUniversity of Oxford; 3D Metal Printing Ltd; Versus ArthritisRecruitingMedial Knee OsteoarthritisUnited Kingdom
-
Max Biocare Pty. Ltd.Completed
Clinical Trials on Intra articular injection Group
-
Istanbul UniversityRecruiting
-
Dalia Salah SaifUnknownRA - Rheumatoid ArthritisEgypt
-
St George's, University of LondonWellcome Trust; Rosetrees TrustUnknownRheumatoid Arthritis | Osteoarthritis, Knee | Psoriatic Arthritis | SpondyloarthritisUnited Kingdom
-
Sisli Hamidiye Etfal Training and Research HospitalCompleted
-
University Hospital TuebingenUnknownJuvenile Idiopathic ArthritisGermany
-
Fidia Farmaceutici s.p.a.UnknownKnee OsteoarthritisUnited States
-
LabrhaStatitecCompletedKnee OsteoarthritisFrance
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Bone Therapeutics S.ACompleted
-
Slocum Research & Education FoundationSlocum Center for Orthopedics & Sports MedicineUnknownAnkle Arthropathy | Ankle ArthritisUnited States