TranscutaneousNCT06710782
Transcutaneous Pulsed Radiofrequency Application Plus Genicular Nerve Block Versus Intraarticular Hyaluronic Acid Injection for Management of Chronic Pain in Knee Osteoarthritis.
A study testing Hyaluronic acid and Transcutaneous pulsed radiofrequency in people with Transcutaneous and Pulsed Radiofrequency, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the present study is to compare the analgesic efficacy of combined transcutaneous pulsed radiofrequency plus genicular nerve block with bupivacaine plus corticosteroid versus intraarticular Hyaluronic acid injections, in terms of clinical and functional parameters, in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Transcutaneous, Pulsed Radiofrequency, Genicular Nerve Block
- What is being tested?
- Hyaluronic acid and Transcutaneous pulsed radiofrequency
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Jul 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
The aim of the present study is to compare the analgesic efficacy of combined transcutaneous pulsed radiofrequency plus genicular nerve block with bupivacaine plus corticosteroid versus intraarticular Hyaluronic acid injections, in terms of clinical and functional parameters, in patients with knee osteoarthritis.
Read the 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.
- Conditions
- Transcutaneous, Pulsed Radiofrequency, Genicular Nerve Block, Intraarticular, Hyaluronic Acid, Chronic Pain
- Being tested
- Hyaluronic acid, Transcutaneous pulsed radiofrequency
- Medical subject headings
- Chronic Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
Patients underwent intra-articular hyaluronic acid injection.
Transcutaneous pulsed radiofrequencyDevice
Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid group | Experimental | Patients underwent intra-articular hyaluronic acid injection. Receives: Drug: Hyaluronic acid |
| Transcutaneous pulsed radiofrequency group | Experimental | Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block. Receives: Device: Transcutaneous pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
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."
Measured: 3 month after injection
Secondary outcomes (4)
Functional status
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.
Measured: 3 month after injection
Daily activity
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.
Measured: 3 month after injection
Analgesic requirement
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
Measured: 3 month after injection
Adverse events
Adverse events were recorded such as toxicity of local anesthetic drug occur, the research was stopped and was cleared to ehtical committees.
Measured: 3 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Aug 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TranscutaneousStudies of the same condition, open and under way.
- More trials run by Tanta 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hashem Mohammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710782
- Sponsor's protocol ID
- 36264MS262/7/23
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06710782
- Acronym / sponsor ID
- 36264MS262/7/23
- Conditions
- Transcutaneous, Pulsed Radiofrequency, Genicular Nerve Block, Intraarticular, Hyaluronic Acid, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 Nov 2024 (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.
The aim of the present study is to compare the analgesic efficacy of combined transcutaneous pulsed radiofrequency plus genicular nerve block with bupivacaine plus corticosteroid versus intraarticular Hyaluronic acid injections, in terms of clinical and functional parameters, in patients with knee osteoarthritis.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid group | Experimental | Drug: Hyaluronic acidPatients underwent intra-articular hyaluronic acid injection. |
| Transcutaneous pulsed radiofrequency group | Experimental | Device: Transcutaneous pulsed radiofrequencyPatients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Hyaluronic acidPatients underwent intra-articular hyaluronic acid injection. | Drug | Hyaluronic Acid group |
| Transcutaneous pulsed radiofrequencyPatients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block. | Device | Transcutaneous pulsed radiofrequency group |
Primary outcome
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."
4 secondary outcomes
Functional status
Time frame: 3 month after injection
Daily activity
Time frame: 3 month after injection
Analgesic requirement
Time frame: 3 month after injection
Adverse events
Time frame: 3 month after injection
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 Nov 2024.
- Individual participant dataSharing planned: Yes. The data was available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid and Transcutaneous pulsed radiofrequency in people with Transcutaneous and Pulsed Radiofrequency, run by Tanta 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 6 inclusion and 10 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 Nov 2024. 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?
Degree of pain (time frame: 3 month after injection). 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 Nov 2024.