Osteoarthritis, KneeUSPRFGENOAKNCT02915120
Ultrasound-Guided Pulsed Radiofrequency In The Treatment Of Patients With Osteoarthritis Knee (USPRFGENOAK)
A study testing Real Pulsed Radiofrequency in people with Osteoarthritis, Knee, run by Hospital Son Llatzer at 1 site in Spain.
Trial summary
The purpose of this study is to determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following a double diagnostic genicular nerve blocks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Real Pulsed Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2017to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Chronic knee pain with pain intensity of at least 4 out 10 on the VAS on most or all days for more than 3 months
- Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
- Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2
- Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.
Who cannot join
- The patients with secondary osteoarthritis of knees
- Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
- Previous radiofrequency ablation treatment for similar symptoms.
- Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
- Active systemic or local infections at the site of proposed needle and electrode placement.
- Coagulopathy or other bleeding disorder
Show all 10Show fewer
- Cognitive deficit.
- Unstable medical or psychiatric illness.
- Previous knee joint replacement surgery
- Patients missing two or more appointments consecutively were excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Son Llatzer University Hospital
Palma, Balear Islands, 07198
Javier Mata, MD, 0034871202133 ext. 1600, jmata@hsll.es
About this study
Official title: Ultrasound-Guided Pulsed Radiofrequency Of The Genicular Nerves In The Treatment Of Patients With Osteoarthritis Knee Pain: Randomized, Double-Blind, Placebo Controled Trial
The purpose of this study is to determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following a double diagnostic genicular nerve blocks.
Read the detailed description
Osteoarthritis of the knee (kOA) is one of the main causes of disability. Population-based studies revealed that symptomatic kOA is present in 20-30% of the elderly population aged >65 years, and its prevalence is increasing due in part to the aging of the population. The goals of management of patients with kOA are to control pain and to minimize disability. Evidence-based guidelines from National Institute of Health and Clinical Excellence (NICE) and Osteoarthritis Research International (OARSI) suggest that the treatment should be multidisciplinary. Optimal management requires a combination of non-pharmacological (changes in lifestyle, pacing of activities, weight reduction, regular aerobic, acupuncture, muscle strengthening and range of motion exercises) and pharmacological modalities (paracetamol) when additional treatment is required. Total knee arthroplasty (TKA) should be considered for patients with significant symptoms, and/or functional limitations associated with a reduced health-related quality of life, despite conservative therapy. However, there are some fragile patients who are at high risk during surgery and other patients who are not willing to undergo surgery. Because the number of patients will increase as the population ages, alternative approaches to alleviate their joint pain other than conventional treatments are necessary. Ultrasound-guided pulsed radiofrequency of the genicular has recently become a promising treatment option in the management of osteoarthritis related knee pain.
This study is a randomized, double-blind, placebo-controlled trial, parallel design. 142 out-patients with kOA will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: Ultrasound-Guided Sham Genicular Nerve Pulsed Radiofrequency without active treatment (Sham GENPRF) and Ultrasound-Guided Real Genicular Nerve Pulsed Radiofrequency (Real GENPRF). All patients will be examined before and 1, 3, 6 and 12 months after the treatment (sham or active).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Real Pulsed Radiofrequency, Sham Pulsed Radiofrequency
- Keywords
- Knee pain, osteoarthritis, genicular nerve, ultrasonography, pulsed radiofrequency
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Pulsed RadiofrequencyProcedure or surgery
Pulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the "silent" phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C.
Sham Pulsed RadiofrequencyProcedure or surgery
Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.
| Study group | Role | What they receive |
|---|---|---|
| Real Pulsed Radiofrequency | Active comparator | Before needle insertion, the patient's inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches will be identified under ultrasound guidance. RF needles and probes will be advanced to each of the target nerves under ultrasound guidance. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of < 0.5 mA to identify the nerve position, the current intensity (mA) will be reduced at < 0,2 mA. During the sensorial stimulation, the patients will be asked if they feel tingling, pain, or discomfort inside the knee. The RF probe will be maintained in place until one of those feelings is elicited. In order to avoid inactivating motor nerves, the nerve will be tested for the absence of fasciculation in the the lower extremity on stimulation of 0,5 mA at 2 Hz. Receives: Procedure: Real Pulsed Radiofrequency |
| Sham Pulsed Radiofrequency | Sham comparator | Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised. Receives: Procedure: Sham Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in visual analogue scale (VAS)
The VAS is a continuous scale made up of a 100-mm, unmarked, horizontal line, upon which the subject makes a hash mark depending on the amount of pain felt; a mark on the far left of the line indicates "no pain" (score of 0), and a mark to the far right qualifies as "pain as bad as it could be" or "unbearable pain" (score of 100).
Measured: baseline and the completion of treatment at 12 weeks
Secondary outcomes (15)
Change from Baseline in Goldberg Depression and Anxiety scales
This consists of two subscales (of nine questions for each scale): an anxiety scale (1-9) and a depression scale (10-18). The first questions for each scale (1-4 and 10-13) are preconditioned questions to determine whether the patient should attempt to answer the rest of the questions of the two subscales. Effectively, at least two questions must be answered affirmatively in the first scale (1-4) for the patient to continue; in the second scale, one answer is sufficient for questions 10-13 for the patient to continue with the rest of the questions. This study will use the Spanish version validated by Montón et al.
Measured: at 1 month
Change from Baseline in Goldberg Depression and Anxiety scales
This consists of two subscales (of nine questions for each scale): an anxiety scale (1-9) and a depression scale (10-18). The first questions for each scale (1-4 and 10-13) are preconditioned questions to determine whether the patient should attempt to answer the rest of the questions of the two subscales. Effectively, at least two questions must be answered affirmatively in the first scale (1-4) for the patient to continue; in the second scale, one answer is sufficient for questions 10-13 for the patient to continue with the rest of the questions. This study will use the Spanish version validated by Montón et al.
Measured: at 3 months
Change from Baseline in Goldberg Depression and Anxiety scales
This consists of two subscales (of nine questions for each scale): an anxiety scale (1-9) and a depression scale (10-18). The first questions for each scale (1-4 and 10-13) are preconditioned questions to determine whether the patient should attempt to answer the rest of the questions of the two subscales. Effectively, at least two questions must be answered affirmatively in the first scale (1-4) for the patient to continue; in the second scale, one answer is sufficient for questions 10-13 for the patient to continue with the rest of the questions. This study will use the Spanish version validated by Montón et al.
Measured: at 6 months
Change from Baseline in Goldberg Depression and Anxiety scales
This consists of two subscales (of nine questions for each scale): an anxiety scale (1-9) and a depression scale (10-18). The first questions for each scale (1-4 and 10-13) are preconditioned questions to determine whether the patient should attempt to answer the rest of the questions of the two subscales. Effectively, at least two questions must be answered affirmatively in the first scale (1-4) for the patient to continue; in the second scale, one answer is sufficient for questions 10-13 for the patient to continue with the rest of the questions. This study will use the Spanish version validated by Montón et al.
Measured: up to 1 year
Change from baseline in WOMAC index
The WOMAC scale is used to evaluate the condition of patients with OA of the knee and the hip and includes pain, stiffness, and physical functioning of the joints. This scale measures five items for pain (with a score range of 0-20), two for stiffness (score range of 0-8), and 17 for functional limitation (score range of 0-68). The physical functioning questions cover everyday activities. These scales will be used separately and will not be summed. Patients will respond orally to the five levels with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are left unanswered, the scale will be declared invalid. If the patient does not respond to one question, a mean will be taken from the results of the other questions. The range will be 0-98.
Measured: at 1 month
Change from baseline in WOMAC index
The WOMAC scale is used to evaluate the condition of patients with OA of the knee and the hip and includes pain, stiffness, and physical functioning of the joints. This scale measures five items for pain (with a score range of 0-20), two for stiffness (score range of 0-8), and 17 for functional limitation (score range of 0-68). The physical functioning questions cover everyday activities. These scales will be used separately and will not be summed. Patients will respond orally to the five levels with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are left unanswered, the scale will be declared invalid. If the patient does not respond to one question, a mean will be taken from the results of the other questions. The range will be 0-98.
Measured: at 3 months
Change from baseline in WOMAC index
The WOMAC scale is used to evaluate the condition of patients with OA of the knee and the hip and includes pain, stiffness, and physical functioning of the joints. This scale measures five items for pain (with a score range of 0-20), two for stiffness (score range of 0-8), and 17 for functional limitation (score range of 0-68). The physical functioning questions cover everyday activities. These scales will be used separately and will not be summed. Patients will respond orally to the five levels with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are left unanswered, the scale will be declared invalid. If the patient does not respond to one question, a mean will be taken from the results of the other questions. The range will be 0-98.
Measured: at 6 months
Change from baseline in WOMAC index
The WOMAC scale is used to evaluate the condition of patients with OA of the knee and the hip and includes pain, stiffness, and physical functioning of the joints. This scale measures five items for pain (with a score range of 0-20), two for stiffness (score range of 0-8), and 17 for functional limitation (score range of 0-68). The physical functioning questions cover everyday activities. These scales will be used separately and will not be summed. Patients will respond orally to the five levels with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are left unanswered, the scale will be declared invalid. If the patient does not respond to one question, a mean will be taken from the results of the other questions. The range will be 0-98.
Measured: up to 1 year
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
This questionnaire will have four questions developed according the EUROHIS (European Health Interview Survey) recommendations in order to harmonize the information regarding medicine use [31]. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ("Have you taken any pain medicine prescribed by your general practitioner?") as well as any medication not prescribed by their general practitioner ("Have you taken any pain medicine not prescribed by your general practitioner") and (2) whether or not their prescribed and non-prescribed pain medication use has increased or decreased.
Measured: at 1 month
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
This questionnaire will have four questions developed according the EUROHIS (European Health Interview Survey) recommendations in order to harmonize the information regarding medicine use [31]. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ("Have you taken any pain medicine prescribed by your general practitioner?") as well as any medication not prescribed by their general practitioner ("Have you taken any pain medicine not prescribed by your general practitioner") and (2) whether or not their prescribed and non-prescribed pain medication use has increased or decreased.
Measured: at 3 months
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
This questionnaire will have four questions developed according the EUROHIS (European Health Interview Survey) recommendations in order to harmonize the information regarding medicine use [31]. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ("Have you taken any pain medicine prescribed by your general practitioner?") as well as any medication not prescribed by their general practitioner ("Have you taken any pain medicine not prescribed by your general practitioner") and (2) whether or not their prescribed and non-prescribed pain medication use has increased or decreased.
Measured: at 6 months
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
This questionnaire will have four questions developed according the EUROHIS (European Health Interview Survey) recommendations in order to harmonize the information regarding medicine use [31]. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ("Have you taken any pain medicine prescribed by your general practitioner?") as well as any medication not prescribed by their general practitioner ("Have you taken any pain medicine not prescribed by your general practitioner") and (2) whether or not their prescribed and non-prescribed pain medication use has increased or decreased.
Measured: up to 1 year
Change from baseline in a visual analogue scale (VAS)
The VAS is a continuous scale made up of a 100-mm, unmarked, horizontal line, upon which the subject makes a hash mark depending on the amount of pain felt; a mark on the far left of the line indicates "no pain" (score of 0), and a mark to the far right qualifies as "pain as bad as it could be" or "unbearable pain" (score of 100).
Measured: at 1 month
Change from baseline in a visual analogue scale (VAS)
The VAS is a continuous scale made up of a 100-mm, unmarked, horizontal line, upon which the subject makes a hash mark depending on the amount of pain felt; a mark on the far left of the line indicates "no pain" (score of 0), and a mark to the far right qualifies as "pain as bad as it could be" or "unbearable pain" (score of 100).
Measured: at 6 months
Change from baseline in a visual analogue scale (VAS)
The VAS is a continuous scale made up of a 100-mm, unmarked, horizontal line, upon which the subject makes a hash mark depending on the amount of pain felt; a mark on the far left of the line indicates "no pain" (score of 0), and a mark to the far right qualifies as "pain as bad as it could be" or "unbearable pain" (score of 100).
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start27 Mar 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Mata, Hospital Son Llatzer
- Investigators
- Javier Mata, MD, Principal investigator, Son Llatzer University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915120
- Sponsor's protocol ID
- RFPGEN-001
- Acronym
- USPRFGENOAK
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2016
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No later than 3 years after the study will have ended a completely deidentified data set will deliver to an appropriate data archive for sharing purposes
Publications
Rubinstein SM, van Tulder M. A best-evidence review of diagnostic procedures for neck and low-back pain. Best Pract Res Clin Rheumatol. 2008 Jun;22(3):471-82. doi: 10.1016/j.berh.2007.12.003.
PubMed 18519100Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PubMed 21055873Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.
PubMed 24373908Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.
PubMed 23942592Kesikburun S, Yasar E, Uran A, Adiguzel E, Yilmaz B. Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Pain Physician. 2016 Jul;19(5):E751-9.
PubMed 27389118Vas L, Pai R, Khandagale N, Pattnaik M. Pulsed radiofrequency of the composite nerve supply to the knee joint as a new technique for relieving osteoarthritic pain: a preliminary report. Pain Physician. 2014 Nov-Dec;17(6):493-506.
PubMed 25415774Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
PubMed 21463469Cosman ER Jr, Dolensky JR, Hoffman RA. Factors that affect radiofrequency heat lesion size. Pain Med. 2014 Dec;15(12):2020-36. doi: 10.1111/pme.12566. Epub 2014 Oct 14.
PubMed 25312825Yasar E, Kesikburun S, Kilic C, Guzelkucuk U, Yazar F, Tan AK. Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. Pain Physician. 2015 Sep-Oct;18(5):E899-904.
PubMed 26431143Kvarstein G. A new target for radiofrequency neurotomy? Pain. 2011 Mar;152(3):465-466. doi: 10.1016/j.pain.2010.09.037. Epub 2010 Oct 18. No abstract available.
PubMed 20961686Lin ML, Lin MH, Fen JJ, Lin WT, Lin CW, Chen PQ. A comparison between pulsed radiofrequency and electro-acupuncture for relieving pain in patients with chronic low back pain. Acupunct Electrother Res. 2010;35(3-4):133-46. doi: 10.3727/036012910803860940.
PubMed 21319602Bhatia A, Peng P, Cohen SP. Radiofrequency Procedures to Relieve Chronic Knee Pain: An Evidence-Based Narrative Review. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):501-10. doi: 10.1097/AAP.0000000000000414.
PubMed 27281721Manzano D, Jimenez F, Blasi M. Ultrasound-guided pain interventions in the knee region. Techniques in Regional Anesthesia and Pain Management. 2013;17:131-9.
Franco CD, Buvanendran A, Petersohn JD, Menzies RD, Menzies LP. Innervation of the Anterior Capsule of the Human Knee: Implications for Radiofrequency Ablation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):363-8. doi: 10.1097/AAP.0000000000000269.
PubMed 26066383Mata J, Valenti P, Hernandez B, Mir B, Aguilar JL. Study protocol for a randomised controlled trial of ultrasound-guided pulsed radiofrequency of the genicular nerves in the treatment of patients with osteoarthritis knee pain. BMJ Open. 2017 Nov 3;7(11):e016377. doi: 10.1136/bmjopen-2017-016377.
PubMed 29102985
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Pulsed Radiofrequency Of The Genicular Nerves In The Treatment Of Patients With Osteoarthritis Knee Pain: Randomized, Double-Blind, Placebo Controled Trial
- ClinicalTrials.gov ID
- NCT02915120
- Acronym / sponsor ID
- USPRFGENOAK / RFPGEN-001
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee pain, osteoarthritis, genicular nerve, ultrasonography, pulsed radiofrequency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- 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 purpose of this study is to determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following a double diagnostic genicular nerve blocks.
Detailed description
Osteoarthritis of the knee (kOA) is one of the main causes of disability. Population-based studies revealed that symptomatic kOA is present in 20-30% of the elderly population aged >65 years, and its prevalence is increasing due in part to the aging of the population. The goals of management of patients with kOA are to control pain and to minimize disability. Evidence-based guidelines from National Institute of Health and Clinical Excellence (NICE) and Osteoarthritis Research International (OARSI) suggest that the treatment should be multidisciplinary. Optimal management requires a combination of non-pharmacological (changes in lifestyle, pacing of activities, weight reduction, regular aerobic, acupuncture, muscle strengthening and range of motion exercises) and pharmacological modalities (paracetamol) when additional treatment is required. Total knee arthroplasty (TKA) should be considered for patients with significant symptoms, and/or functional limitations associated with a reduced health-related quality of life, despite conservative therapy. However, there are some fragile patients who are at high risk during surgery and other patients who are not willing to undergo surgery. Because the number of patients will increase as the population ages, alternative approaches to alleviate their joint pain other than conventional treatments are necessary. Ultrasound-guided pulsed radiofrequency of the genicular has recently become a promising treatment option in the management of osteoarthritis related knee pain.
This study is a randomized, double-blind, placebo-controlled trial, parallel design. 142 out-patients with kOA will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: Ultrasound-Guided Sham Genicular Nerve Pulsed Radiofrequency without active treatment (Sham GENPRF) and Ultrasound-Guided Real Genicular Nerve Pulsed Radiofrequency (Real GENPRF). All patients will be examined before and 1, 3, 6 and 12 months after the treatment (sham or active).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Pulsed Radiofrequency | Active comparator | Procedure: Real Pulsed RadiofrequencyBefore needle insertion, the patient's inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches will be identified under ultrasound guidance. RF needles and probes will be advanced to each of the target nerves under ultrasound guidance. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of < 0.5 mA to identify the nerve position, the current intensity (mA) will be reduced at < 0,2 mA. During the sensorial stimulation, the patients will be asked if they feel tingling, pain, or discomfort inside the knee. The RF probe will be maintained in place until one of those feelings is elicited. In order to avoid inactivating motor nerves, the nerve will be tested for the absence of fasciculation in the the lower extremity on stimulation of 0,5 mA at 2 Hz. |
| Sham Pulsed Radiofrequency | Sham comparator | Procedure: Sham Pulsed RadiofrequencyControl patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic knee pain with pain intensity of at least 4 out 10 on the VAS on most or all days for more than 3 months
- Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
- Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2
- Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.
Key exclusion criteria (10 listed)
- The patients with secondary osteoarthritis of knees
- Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
- Previous radiofrequency ablation treatment for similar symptoms.
- Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
- Active systemic or local infections at the site of proposed needle and electrode placement.
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 |
|---|---|---|
| Real Pulsed RadiofrequencyPulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the "silent" phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C. | Procedure or surgery | Real Pulsed Radiofrequency |
| Sham Pulsed RadiofrequencyControl patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised. | Procedure or surgery | Sham Pulsed Radiofrequency |
Primary outcome
Changes from baseline in visual analogue scale (VAS)
Time frame: baseline and the completion of treatment at 12 weeks
The VAS is a continuous scale made up of a 100-mm, unmarked, horizontal line, upon which the subject makes a hash mark depending on the amount of pain felt; a mark on the far left of the line indicates "no pain" (score of 0), and a mark to the far right qualifies as "pain as bad as it could be" or "unbearable pain" (score of 100).
15 secondary outcomes
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: at 1 month
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: at 3 months
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: at 6 months
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: up to 1 year
Change from baseline in WOMAC index
Time frame: at 1 month
Change from baseline in WOMAC index
Time frame: at 3 months
Change from baseline in WOMAC index
Time frame: at 6 months
Change from baseline in WOMAC index
Time frame: up to 1 year
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
Time frame: at 1 month
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
Time frame: at 3 months
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
Time frame: at 6 months
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire Changes in baseline use of medication
Time frame: up to 1 year
Change from baseline in a visual analogue scale (VAS)
Time frame: at 1 month
Change from baseline in a visual analogue scale (VAS)
Time frame: at 6 months
Change from baseline in a visual analogue scale (VAS)
Time frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 18519100Rubinstein SM, van Tulder M. A best-evidence review of diagnostic procedures for neck and low-back pain. Best Pract Res Clin Rheumatol. 2008 Jun;22(3):471-82. doi: 10.1016/j.berh.2007.12.003.
- Background: PubMed 21055873Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
- Background: PubMed 24373908Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.
- Background: PubMed 23942592Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.
- Background: PubMed 27389118Kesikburun S, Yasar E, Uran A, Adiguzel E, Yilmaz B. Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Pain Physician. 2016 Jul;19(5):E751-9.
- Background: PubMed 25415774Vas L, Pai R, Khandagale N, Pattnaik M. Pulsed radiofrequency of the composite nerve supply to the knee joint as a new technique for relieving osteoarthritic pain: a preliminary report. Pain Physician. 2014 Nov-Dec;17(6):493-506.
- Background: PubMed 21463469Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
- Background: PubMed 25312825Cosman ER Jr, Dolensky JR, Hoffman RA. Factors that affect radiofrequency heat lesion size. Pain Med. 2014 Dec;15(12):2020-36. doi: 10.1111/pme.12566. Epub 2014 Oct 14.
- Background: PubMed 26431143Yasar E, Kesikburun S, Kilic C, Guzelkucuk U, Yazar F, Tan AK. Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. Pain Physician. 2015 Sep-Oct;18(5):E899-904.
- Background: PubMed 20961686Kvarstein G. A new target for radiofrequency neurotomy? Pain. 2011 Mar;152(3):465-466. doi: 10.1016/j.pain.2010.09.037. Epub 2010 Oct 18. No abstract available.
- Background: PubMed 21319602Lin ML, Lin MH, Fen JJ, Lin WT, Lin CW, Chen PQ. A comparison between pulsed radiofrequency and electro-acupuncture for relieving pain in patients with chronic low back pain. Acupunct Electrother Res. 2010;35(3-4):133-46. doi: 10.3727/036012910803860940.
- Background: PubMed 27281721Bhatia A, Peng P, Cohen SP. Radiofrequency Procedures to Relieve Chronic Knee Pain: An Evidence-Based Narrative Review. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):501-10. doi: 10.1097/AAP.0000000000000414.
- Individual participant dataSharing planned: Yes. No later than 3 years after the study will have ended a completely deidentified data set will deliver to an appropriate data archive for sharing purposes
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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.
Javier Mata, MD principal investigator
Son Llatzer University 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 Real Pulsed Radiofrequency in people with Osteoarthritis, Knee, run by Hospital Son Llatzer at 1 site in Spain.
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 4 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: looking for participants now, as of the sponsor's last update on 12 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 Spain. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Mata, MD (0034871201233 ext. 1600, jmata@hsll.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in visual analogue scale (VAS) (time frame: baseline and the completion of treatment at 12 weeks). 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 NCT02915120, which also lists 15 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 12 Nov 2024.