Genicular Nerve and Intra-articular Radiofrequency Versus Platelet Rich Plasma Injection for Knee Osteoarthritis
Primary Purpose
Chronic Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed radiofrequency (P-RF)
Platelet rich plasma (PRP)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients experienced unilateral lesion with a history of chronic (≥4 months)
- Pain or swelling of the knee and imaging findings (radiography or magnetic resonance imaging [MRI]) of degenerative changes of the joint
- Patients shall to be clinically unresponsive to conservative treatment modalities
Exclusion Criteria:
- Diabetes
- Rheumatic diseases
- Coagulopathies
- Severe cardiovascular diseases
- Infections
- Immunosuppression
- Patients receiving anticoagulants
- Use of non-steroidal anti-inflammatory drugs in the 5 days before blood donation
- Hemoglobin concentration less than 10 g/dl
- Platelet count less than 150,000/cubic mm.
Sites / Locations
- Mansoura University, Emergency Hospital, Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Pulsed radiofrequency (P-RF)
Platelet rich plasma (PRP)
Arm Description
Patients will receive both intra articular RF and genicular nerve RF ablation
Patients will receive intra-articular platelet rich plasma (PRP)
Outcomes
Primary Outcome Measures
Pain score
The intensity of pain at rest will be measured with a 10-cm visual analogue scale (VAS-pain). (VAS) identifying 0 as no pain and 10 as worst imaginable pain.
Secondary Outcome Measures
Knee function
Subjective knee functionality will be evaluated using the Western Ontario and McMaster's Universities Osteoarthritis (WOMAC) Index.WOMAC Index assesses disability in three subscales, including pain, severity of physical function and joint stiffness. This scale consists of 24 items: five items for pain assessment, two items for assessment of the severity of joint stiffness and 17 items for assessment of physical function. The patient answers the questions and then receives a cumulative score in each of the 3 areas (pain, 0-20; stiffness, 0-8; physical function, 0-68). Higher scores are representative of greater pain and stiffness as well as worsened physical capability.
Patient satisfaction
Patient satisfaction when it comes to perceived improvement in symptoms after the treatment will evaluated using the Patient Global Impression Scale of Improvement (PGI-I) where; Very much better = 1, Much better = 2, A little better= 3, No change =4, A little worse=5, Much worse=6, Very much worse =7,
Full Information
NCT ID
NCT03379883
First Posted
December 15, 2017
Last Updated
December 15, 2017
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT03379883
Brief Title
Genicular Nerve and Intra-articular Radiofrequency Versus Platelet Rich Plasma Injection for Knee Osteoarthritis
Official Title
Combined Ultrasound Guided Genicular Nerve and Intra-articular Pulsed Radiofrequency Versus Intra-articular Platelet Rich Plasma Injection for Chronic Knee Osteoarthritis; A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The social impact of degenerative diseases such as articular cartilage pathology and osteoarthritis (OA) is steadily increasing, because of the continued rise in the mean age of the active population. A variety of noninvasive solutions have been proposed for pain treatment, improvement in function and disability, and ultimately, modification of the course of severe cartilage lesions and OA, with variable success rates. Intra articular and genicular nerves radiofrequency (RF) is a minimally invasive technique that usually aims at the neuropathic pain. One important mechanism for the chronic pain mediated by OA is peripheral sensitization, which increases the transmission of pain signals. Through conduction block in pain-transmitting nerve fibers by thermal damage, RF could ease pain without destroying the antennal nerve. The role of growth factors (GFs) in chondral repair is now widely investigated in vitro and in vivo.
Platelet-rich plasma (PRP) is a simple, low cost, and minimally invasive method that allows one to obtain from the blood a natural concentrate of autologous GFs.
Detailed Description
The aim of this study is to compare the efficacy of intra articular Platelet Rich Plasma (PRP) injection versus combined ultrasound guided intra articular and genicular nerve pulsed radiofrequency on chronic knee pain in patients with knee osteoarthritis.
The regeneration capacity of cartilage is limited because of its isolation from systemic regulation and its lack of vessels and nerve supply. Osteoarthritis (OA) has a major impact on functioning and independence and ranks among the top 10 causes of disability worldwide
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Knee Osteoarthritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Single blind (investigator) study
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulsed radiofrequency (P-RF)
Arm Type
Placebo Comparator
Arm Description
Patients will receive both intra articular RF and genicular nerve RF ablation
Arm Title
Platelet rich plasma (PRP)
Arm Type
Experimental
Arm Description
Patients will receive intra-articular platelet rich plasma (PRP)
Intervention Type
Procedure
Intervention Name(s)
Pulsed radiofrequency (P-RF)
Intervention Description
Intra articular RF
Insertion of the RF cannula within the joint. The recommended parameters are a pulse width of 20 msec and a rate of 2 Hz at 42°C for 10min.
Genicular nerve RF ablation.
The RF probe will be placed. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of < 0.6 V
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma (PRP)
Intervention Description
Under ultrasound guidance while the patients in a sitting position. In total, 3 to 8 mL of PRP will be injected via the inta-articular route
Primary Outcome Measure Information:
Title
Pain score
Description
The intensity of pain at rest will be measured with a 10-cm visual analogue scale (VAS-pain). (VAS) identifying 0 as no pain and 10 as worst imaginable pain.
Time Frame
For 6 months after intervention
Secondary Outcome Measure Information:
Title
Knee function
Description
Subjective knee functionality will be evaluated using the Western Ontario and McMaster's Universities Osteoarthritis (WOMAC) Index.WOMAC Index assesses disability in three subscales, including pain, severity of physical function and joint stiffness. This scale consists of 24 items: five items for pain assessment, two items for assessment of the severity of joint stiffness and 17 items for assessment of physical function. The patient answers the questions and then receives a cumulative score in each of the 3 areas (pain, 0-20; stiffness, 0-8; physical function, 0-68). Higher scores are representative of greater pain and stiffness as well as worsened physical capability.
Time Frame
For 6 months after intervention
Title
Patient satisfaction
Description
Patient satisfaction when it comes to perceived improvement in symptoms after the treatment will evaluated using the Patient Global Impression Scale of Improvement (PGI-I) where; Very much better = 1, Much better = 2, A little better= 3, No change =4, A little worse=5, Much worse=6, Very much worse =7,
Time Frame
For 6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients experienced unilateral lesion with a history of chronic (≥4 months)
Pain or swelling of the knee and imaging findings (radiography or magnetic resonance imaging [MRI]) of degenerative changes of the joint
Patients shall to be clinically unresponsive to conservative treatment modalities
Exclusion Criteria:
Diabetes
Rheumatic diseases
Coagulopathies
Severe cardiovascular diseases
Infections
Immunosuppression
Patients receiving anticoagulants
Use of non-steroidal anti-inflammatory drugs in the 5 days before blood donation
Hemoglobin concentration less than 10 g/dl
Platelet count less than 150,000/cubic mm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Sultan, MD
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doaa G Diab, MD
Organizational Affiliation
Assistant Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University, Emergency Hospital, Intensive Care Unit
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Genicular Nerve and Intra-articular Radiofrequency Versus Platelet Rich Plasma Injection for Knee Osteoarthritis
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