Osteoarthritis, KneeNCT05700253
Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients
A study testing Cooled Radiofrequency Ablation and Hyaluronic Acid Injection in people with Osteoarthritis, Knee and Pain, run by Changi General Hospital at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to compare two different pain relief techniques (cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injection) for patients with knee osteoarthritis (OA) over a period of 6 months. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- Cooled Radiofrequency Ablation and Hyaluronic Acid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2023to Sep 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- Chronic knee pain for longer than 3 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
- Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs] etc.)
- Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
- Pain on VAS ≥ 6 on an 11-point scale for the index knee
Show all 12Show fewer
- Radiologic confirmation of arthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
- An intra-articular HA injection is indicated as an appropriate treatment option
- WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale
- Agree to see one physician (study physician) for knee pain during the study period
- Willing to delay any surgical intervention for the index knee for the period of the study follow up
- Willing to comply with the requirements of this protocol for the full duration of the study
Who cannot join
- Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
- Evidence of neuropathic pain secondary to other causes (e.g., sciatica), apart from OA knee, affecting the index knee
- Previous or pending lower limb amputation
- Intra-articular steroid or PRP injection or Radiofrequency lesioning into the index knee within 180 days from randomization
- Hyaluronic acid injection, PRP injection, stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
- Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
Show all 24Show fewer
- Clinically significant ligamentous laxity of the index knee
- Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations
- Body mass index (BMI) > 45 kg/m2 or < 18 kg/m2
- Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns
- Pending or active compensation claim, litigation, or disability remuneration (secondary gain)
- Pregnant, nursing or intent of becoming pregnant during the study period
- Chronic pain associated with significant psychosocial dysfunction
- Patients with known psychiatric history including severe mental health issues.
- Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry)
- Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
- History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is not correctable
- Identifiable anatomical variability that would materially alter the procedure as described in the protocol
- Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse
- Current prescribed opioid medications greater than 60 milligrams morphine equivalent daily opioid dose
- Uncontrolled immunosuppression (e.g., AIDS, cancer, diabetes, etc.)
- Subject currently implanted with pacemaker, stimulator or defibrillator
- Participating in another clinical trial/investigation within 30 days prior to signing informed consent
- Subject unwilling or unable to comply with follow up schedule or protocol requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Pain Outcomes of Cooled Radiofrequency Ablation and Hyaluronic Acid Therapies for Chronic Osteoarthritis Knee Patients
The goal of this clinical trial is to compare two different pain relief techniques (cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injection) for patients with knee osteoarthritis (OA) over a period of 6 months. The main questions it aims to answer are:
- the extent of reduction of pain score and the proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment in the two treatment groups.
- the safety of the two treatment modalities.
Participants will undergo a nerve block test to determine if they would experience pain relief from blocking of nerve signals. Responders will be randomised to receive one of the two treatments for their knee pain. Researchers will compare the pain intensity of CRFA and HA injection groups at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment using validated questionnaires.
Read the detailed description
This study will be a single-centred, open-label, prospective randomized controlled study to compare the extent of OA-related knee pain relief between subjects who undergo radiofrequency lesioning (COOLIEF* CRFA; Avanos Medical) of the genicular nerves and subjects who receive a single intra-articular HA injection (Synvisc-One [Hylan G-F 20]; Sanofi). Study subjects will receive CRFA or HA injection in a 1:1 randomization scheme, with post-treatment data collection at 2 weeks, 1 month, 3 months and 6 months. Six months was chosen as the duration of follow-up as that is the expected duration of medical improvement following HA injection for chronic knee pain. Knee pain, function, overall subject impressions of treatment, quality of life, pain medication use, and adverse events will be compared among the treatment cohorts. The study is open-label as blinding is not possible due to the differences in administration of injection and CRFA, hence both the patient and the investigator will be aware of the treatment type.
The primary endpoints will be the extent of reduction of pain score measured via 11-point visual analogue scale (VAS). Secondary outcomes will include proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment, patients' overall knee pain score as measured via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjects' perception of treatment effect as measured via Knee injury and Osteoarthritis Outcome Score (KOOS), patients' perception of treatment effect via Global Perceived Effect (GPE) score and health related quality of life via EuroQol-5 Dimensions 5 Level (EQ-5D-5L). Assessments of these study endpoints will be made at baseline, 2 weeks, 1 month, 3 months and 6 months following treatment.
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- Cooled Radiofrequency Ablation, Hyaluronic Acid Injection
- Keywords
- cooled radiofrequency ablation, hyaluronic acid injection
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled Radiofrequency AblationDevice
Image-guided genicular nerve ablation will be performed with the Coolief System (COOLIEF* CRFA; Avanos Medical).
Hyaluronic Acid InjectionDevice
Synvisc-One ([Hylan G-F 20]; Sanofi) will be administered as a single intra-articular dose (6 mL).
| Study group | Role | What they receive |
|---|---|---|
| Cooled Radiofrequency Ablation | Experimental | Relieves pain by blocking pain signals via the deactivation of nerve structures using radiofrequency energy. Receives: Device: Cooled Radiofrequency Ablation |
| Hyaluronic Acid Injection | Active comparator | Injection of hyaluronic acid into the affected knee provides lubrication and shock absorption. Receives: Device: Hyaluronic Acid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of reduction of pain score
11-point Visual Analogue Scale
Measured: 6 months
Secondary outcomes (5)
Proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment.
11-point Visual Analogue Scale
Measured: 6 months
Overall knee pain score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 6 months
Opinion of knee injury and treatment outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 6 months
Perception of treatment effect
Global Perceived Effect (GPE) score
Measured: 6 months
Health related quality of life
EuroQol-5 Dimensions 5 Level (EQ-5D-5L)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prit Anand Singh, Changi General Hospital
- Investigators
- Prit Anand Singh, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700253
- Sponsor's protocol ID
- Osteoarthritis01
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu L, Li Y, Si H, Zeng Y, Li M, Liu Y, Shen B. Radiofrequency Ablation in Cooled Monopolar or Conventional Bipolar Modality Yields More Beneficial Short-Term Clinical Outcomes Versus Other Treatments for Knee Osteoarthritis: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Arthroscopy. 2022 Jul;38(7):2287-2302. doi: 10.1016/j.arthro.2022.01.048. Epub 2022 Feb 12.
PubMed 35157969Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, and Outcomes. J Knee Surg. 2019 Jan;32(1):65-71. doi: 10.1055/s-0038-1675418. Epub 2018 Nov 5.
PubMed 30396206Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree MJ, Badiola I, Lyman J. Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection. BMC Musculoskelet Disord. 2020 Jun 9;21(1):363. doi: 10.1186/s12891-020-03380-5.
PubMed 32517739Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree M, Badiola I, Lyman J. Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation. J Bone Joint Surg Am. 2020 Sep 2;102(17):1501-1510. doi: 10.2106/JBJS.19.00935.
PubMed 32898379Lyman J, Khalouf F, Zora K, DePalma M, Loudermilk E, Guiguis M, Beall D, Kohan L, Chen AF. Cooled radiofrequency ablation of genicular nerves provides 24-Month durability in the management of osteoarthritic knee pain: Outcomes from a prospective, multicenter, randomized trial. Pain Pract. 2022 Jul;22(6):571-581. doi: 10.1111/papr.13139. Epub 2022 Jun 29.
PubMed 35716058
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pain Outcomes of Cooled Radiofrequency Ablation and Hyaluronic Acid Therapies for Chronic Osteoarthritis Knee Patients
- ClinicalTrials.gov ID
- NCT05700253
- Acronym / sponsor ID
- Osteoarthritis01
- Conditions
- Osteoarthritis, Knee, Pain
- Keywords
- cooled radiofrequency ablation, hyaluronic acid injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Jan 2023 (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 goal of this clinical trial is to compare two different pain relief techniques (cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injection) for patients with knee osteoarthritis (OA) over a period of 6 months. The main questions it aims to answer are:
- the extent of reduction of pain score and the proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment in the two treatment groups.
- the safety of the two treatment modalities.
Participants will undergo a nerve block test to determine if they would experience pain relief from blocking of nerve signals. Responders will be randomised to receive one of the two treatments for their knee pain. Researchers will compare the pain intensity of CRFA and HA injection groups at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment using validated questionnaires.
Detailed description
This study will be a single-centred, open-label, prospective randomized controlled study to compare the extent of OA-related knee pain relief between subjects who undergo radiofrequency lesioning (COOLIEF* CRFA; Avanos Medical) of the genicular nerves and subjects who receive a single intra-articular HA injection (Synvisc-One [Hylan G-F 20]; Sanofi). Study subjects will receive CRFA or HA injection in a 1:1 randomization scheme, with post-treatment data collection at 2 weeks, 1 month, 3 months and 6 months. Six months was chosen as the duration of follow-up as that is the expected duration of medical improvement following HA injection for chronic knee pain. Knee pain, function, overall subject impressions of treatment, quality of life, pain medication use, and adverse events will be compared among the treatment cohorts. The study is open-label as blinding is not possible due to the differences in administration of injection and CRFA, hence both the patient and the investigator will be aware of the treatment type.
The primary endpoints will be the extent of reduction of pain score measured via 11-point visual analogue scale (VAS). Secondary outcomes will include proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment, patients' overall knee pain score as measured via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjects' perception of treatment effect as measured via Knee injury and Osteoarthritis Outcome Score (KOOS), patients' perception of treatment effect via Global Perceived Effect (GPE) score and health related quality of life via EuroQol-5 Dimensions 5 Level (EQ-5D-5L). Assessments of these study endpoints will be made at baseline, 2 weeks, 1 month, 3 months and 6 months following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooled Radiofrequency Ablation | Experimental | Device: Cooled Radiofrequency AblationRelieves pain by blocking pain signals via the deactivation of nerve structures using radiofrequency energy. |
| Hyaluronic Acid Injection | Active comparator | Device: Hyaluronic Acid InjectionInjection of hyaluronic acid into the affected knee provides lubrication and shock absorption. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 21 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- Chronic knee pain for longer than 3 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
- Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs] etc.)
- Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
Key exclusion criteria (24 listed)
- Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
- Evidence of neuropathic pain secondary to other causes (e.g., sciatica), apart from OA knee, affecting the index knee
- Previous or pending lower limb amputation
- Intra-articular steroid or PRP injection or Radiofrequency lesioning into the index knee within 180 days from randomization
- Hyaluronic acid injection, PRP injection, stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
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 |
|---|---|---|
| Cooled Radiofrequency AblationImage-guided genicular nerve ablation will be performed with the Coolief System (COOLIEF* CRFA; Avanos Medical). | Device | Cooled Radiofrequency Ablation |
| Hyaluronic Acid InjectionSynvisc-One ([Hylan G-F 20]; Sanofi) will be administered as a single intra-articular dose (6 mL). | Device | Hyaluronic Acid Injection |
Primary outcome
Extent of reduction of pain score
Time frame: 6 months
11-point Visual Analogue Scale
5 secondary outcomes
Proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment.
Time frame: 6 months
Overall knee pain score
Time frame: 6 months
Opinion of knee injury and treatment outcomes
Time frame: 6 months
Perception of treatment effect
Time frame: 6 months
Health related quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 35157969Wu L, Li Y, Si H, Zeng Y, Li M, Liu Y, Shen B. Radiofrequency Ablation in Cooled Monopolar or Conventional Bipolar Modality Yields More Beneficial Short-Term Clinical Outcomes Versus Other Treatments for Knee Osteoarthritis: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Arthroscopy. 2022 Jul;38(7):2287-2302. doi: 10.1016/j.arthro.2022.01.048. Epub 2022 Feb 12.
- Background: PubMed 30396206Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, and Outcomes. J Knee Surg. 2019 Jan;32(1):65-71. doi: 10.1055/s-0038-1675418. Epub 2018 Nov 5.
- Background: PubMed 32517739Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree MJ, Badiola I, Lyman J. Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection. BMC Musculoskelet Disord. 2020 Jun 9;21(1):363. doi: 10.1186/s12891-020-03380-5.
- Background: PubMed 32898379Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree M, Badiola I, Lyman J. Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation. J Bone Joint Surg Am. 2020 Sep 2;102(17):1501-1510. doi: 10.2106/JBJS.19.00935.
- Background: PubMed 35716058Lyman J, Khalouf F, Zora K, DePalma M, Loudermilk E, Guiguis M, Beall D, Kohan L, Chen AF. Cooled radiofrequency ablation of genicular nerves provides 24-Month durability in the management of osteoarthritic knee pain: Outcomes from a prospective, multicenter, randomized trial. Pain Pract. 2022 Jul;22(6):571-581. doi: 10.1111/papr.13139. Epub 2022 Jun 29.
- Avanos Coolief SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Prit Anand Singh principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooled Radiofrequency Ablation and Hyaluronic Acid Injection in people with Osteoarthritis, Knee and Pain, run by Changi General Hospital at 1 site in Singapore.
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 12 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seok Hwee Koo, PhD (+6568504929, seok_hwee_koo@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of reduction of pain score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700253, which also lists 5 linked publications.
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 26 Jan 2023.