Transcutaneous Pulsed Radiofrequency Application Plus Genicular Nerve Block Versus Intraarticular Hyaluronic Acid Injection for Management of Chronic Pain in Knee Osteoarthritis.
A Comparative Study Between Transcutaneous Pulsed Radiofrequency Application Plus Genicular Nerve Block Versus Intra-Articular Hyaluronic Acid Injection for Management of Chronic Pain in Knee Osteo-arthritis: A Prospective Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total knee arthroplasty is commonly used as a surgical option for the treatment of symptomatic knee osteoarthritis to relieve pain and improve function, although it is associated with increased perioperative morbidity and mortality, particularly in older patients with co morbidities. Despite high success rates after total knee arthroplasty , a significant number of patients report suffering from postoperative pain, which can be worse than reported preoperative pain.
As an alternative approach, radiofrequency treatment modalities on the knee joint have been used to reduce knee pain due to osteoarthritis. Genicular nerve block (GNB) is a recently developed therapeutic option for knee osteoarthritis. that targets the three sensory nerves of the knee: superior lateral, superior medial and inferior medial genicular nerve, to inhibit pain transmission to the central nervous system.
Early osteoarthritis. treatment combines non pharmacological techniques with oral pharmacological therapies, intraarticular injections (IAI) of hyaluronic acid (HA), corticosteroid with local anesthetic or platelet-rich plasma (PRP) are used in progressive or very symptomatic stage. Intraarticular injections (IAI) is considered one of first-line treatments in recent studies as it is effective in decreasing pain and safer than oral pharmacological therapies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ElGharbia
-
Tanta, ElGharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged above 40 years.
- Both sexes
- American Society of Anesthesiologists (ASA)physical status I and II.
- Patients radiologically proven symptomatic knee joint osteoarthritis not responding to medical treatment.
- Patients with knee pain of moderate or greater intensity on most or all days for ≥ 3 months, showing significant radiological osteoarthritis (Kellgren-Lawrence grade 1 to 3).
Radiological severity was assessed using the Kellgrenand Lawrence global scale as follow: Grade 0; means absence of radiological finding; grade 1: suspected narrowing of joint space; grade 2 refers to osteophytes and possible narrowing; grade 3 is defined as multiple os-teophytes, definite narrowing of joint space and grade 4 comprises large osteophytes, marked narrowing of joint space.
Exclusion Criteria:
- Patient refusal.
- Patients who show improvement on medical treatment, patients on an oral, topical, or intra-articular steroid during the 4 weeks before the study; patients with an oral, topical, or suppository non-steroidal anti-inflammatory drugs within 2 weeks before the study.
- Patients having secondary knee osteoarthritis.
- Patients with severe osteoarthritis.(K/L grade >3) in a location other than the knee joint.
- Patients with rheumatoid arthritis.
- Patients with joint replacement surgery in either knee and/or a hip.
- Patients with meniscal tear, ligament injury, bursitis, and popliteal cyst and blood investigations suggestive of any infection.
- Morbid obese patients (body mass index (BMI) of >40 kg/m2)
- Infection at site of injection.
- Bleeding diathesis and coagulopathy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyaluronic Acid group
Patients underwent intra-articular hyaluronic acid injection.
|
Patients underwent intra-articular hyaluronic acid injection.
|
|
Experimental: Transcutaneous pulsed radiofrequency group
Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block.
|
Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 3 month after injection
|
Assessment of pain severity by visual analog scale (VAS) at the baseline (before injection), 1month and 3month, intervals after injection. The visual analog scale (VAS) score it has 10-cm scale that represents a continuum between "0 = no pain" and "10 = worst pain." |
3 month after injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional status
Time Frame: 3 month after injection
|
Functional status and daily activity via the western ontario and mcmaster universities osteoartheritis index (WOMAC) score before one month and three monthes after injection. The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations. |
3 month after injection
|
|
Daily activity
Time Frame: 3 month after injection
|
Daily activity via the western ontario and mcmaster universities osteoartheritis index (WOMAC) score before one month and three monthes after injection. The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations. |
3 month after injection
|
|
Analgesic requirement
Time Frame: 3 month after injection
|
Analgesic requirement (Dose and frequency of oral acetaminophen intake) for post injection pain if visual analogue scale (VAS) more than 3. Visual Analogue Scale (VAS) used as an effective tool to detect intensity of pain was recorded;"0" represents no pain,"10" worst pain, "1-3" mild pain,"4-6 " moderate pain and" 7-10 " severe pain |
3 month after injection
|
|
Adverse events
Time Frame: 3 month after injection
|
Adverse events were recorded such as toxicity of local anesthetic drug occur, the research was stopped and was cleared to ehtical committees.
|
3 month after injection
|
Collaborators and Investigators
Sponsor
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
- 36264MS262/7/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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