Hip OsteoarthritisNCT06221709
Continuous Radiofrequency in Hip Osteoarthritis Pain: A Randomized Clinical Trial.
A study testing Conventional Radiofrequency (CRF group) in people with Hip Osteoarthritis and Hip Pain Chronic, run by University of Brasilia at 1 site in Brazil.
Trial summary
This will be a prospective, single-center, double-blinded, randomized study designed to compare the efficacy of the intraarticular injection of a corticosteroid and the Conventional Radiofrequency (CRF) of the anterior sensory branches to the hip in controlling pain and improving function related to hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Hip Pain Chronic
- What is being tested?
- Conventional Radiofrequency (CRF group)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2024to 30 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals ≥ 18 years of age, with symptomatic unilateral hip osteoarthritis, grades II and III according to the Kellgreen and Lawrance classification, hip pain for more than six months (medial, anterior, anterolateral, and/or lateral region) will be included.
Who cannot join
- Individuals with radiculopathy and ipsilateral irradiation, osteonecrosis of the femoral head, previous arthroplasty on the hip to be studied or surgical scar that could lead to changes in the anatomy of the hip, cases of high dislocation of the hip, pain exclusively in the posterior region, symptomatic ipsilateral knee osteoarthritis, intra-articular infiltration of corticosteroids or hyaluronic acid in the hip for less than six months, patients with neurological diseases, peripheral neuropathy or psychiatric diseases, use of a pacemaker or Prothrombin Activity Time (INR) > 3.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Rede Sarah Hospitais de Reabilitação
Brasília, Federal District, 70335901
Gilvan F Vaz, MD, +5561991527220, gilvanvaz@gmail.com
Joao M Montecchi, MD, 5511944471992, jmontecchi@gmail.com
About this study
Official title: Continuous Radiofrequency in Hip Osteoarthritis Pain: A Protocol of a Randomized Clinical Trial
This will be a prospective, single-center, double-blinded, randomized study designed to compare the efficacy of the intraarticular injection of a corticosteroid and the Conventional Radiofrequency (CRF) of the anterior sensory branches to the hip in controlling pain and improving function related to hip osteoarthritis.
Read the detailed description
Procedures will be performed in the surgical block of Hospital SARAH, Brasília unit, using an aseptic technique.
All participants will undergo sedation or general anesthesia using a laryngeal mask airway, according to the preference of the anesthetist in the room. The procedure will be performed with the participant positioned in dorsal decubitus, on a radiolucent table, with a small pillow below the knees to promote a slight flexion of 10 to 20 degrees of the hips, leading to relaxation of the joint capsule.
The surgeon will be positioned at the side of the surgical table, facing the affected hip, with the scoping device on the contralateral side, aligned at 90 degrees with the patient, allowing the visualization of anteroposterior images of the affected hip.
For the control group (IAI), a 22G spinal needle will be used, positioned in the anteroposterior direction towards the central portion of the femoral neck, which will be introduced until it trespasses the anterior hip capsule through tactile sensitivity. After verifying the correct positioning with the use of fluoroscopy and infusion of 3 milliliters (ml) of iodinated contrast diluted at 50% (Iomeron® 300, Patheon Italia S.p.A. Ferentino - Italy), an infiltration of 4 ml of 1% Ropivacaine (Ropi®, Cristália, Itapira - São Paulo, Brazil) and 80mg of methylprednisolone 40mg/ml (Predi-Medrol®, União Química, Brasília - Federal District, Brazil) will be performed, totalizing 6 ml of solution.
In the intervention group (IA + CRF), radiofrequency ablation will be performed with the aid of a 22-gauge cannula (Diros Technology Inc, Markham, Ontario, Canada), 10 or 15 cm long, with a 10-mm curved active tip, at a temperature of 90º for 90 seconds. The cannula will be introduced in the region just above the tip of the greater trochanter, lateral to a descending line originating in the anterior superior iliac spine (ASIS), and directed to the medial border of the patella (ASIS - patella). Its introduction will take place in the anteroposterior and lateromedial direction, to reach the region lateral to the anatomical reference known as the teardrop, with an angle of about 20 to 30 craniocaudal degrees about a transverse line on the axis of the thigh. The denervation of the articular branches of the Obturator Nerve (NO) will be performed in 2 cycles, at a temperature of 90 degrees for 90 seconds, starting lateral to the lateral edge of the obturator foramen and inferior to the teardrop, with subsequent repositioning of the cannula about 1 cm lateral to the first point. Both lesions will be preceded by motor stimulation at 2.5 volts (V) to exclude motor branches within the range of action of the active tip followed by the infusion of 2ml of 1% ropivacaine. Then, the cannula will be repositioned in a more cranial location, 2 to 3 cm lateral to the ASIS-patella line, parallel to the superolateral edge of the acetabular dome, to reach the sensory branches of the Femoral Nerve (NF), performing three cycles (from medial to lateral) at the 01, 12, and 11 o'clock positions. The most medial lesion will be preceded by motor stimulation at 2.5 V to exclude motor branches within the active tip's range of action. All three cycles will be followed by 2 ml of 1% ropivacaine infusion. After completion of radiofrequency ablation, IAI of the hip will follow as described for the control group above.
- Conditions
- Hip Osteoarthritis, Hip Pain Chronic
- Being tested
- Conventional Radiofrequency (CRF group), Intraarticular Infiltration ( Control group)
- Keywords
- denervation, Radiofrequency ablation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Radiofrequency (CRF group)Procedure or surgery
Also called Radioablation
Radiofrequency will be performed with a 22-gauge CRF cannula, 10/15 cm long, 10mm curved active tip, at 90º for 90 seconds, introduced in the anteroposterior and lateromedial directions, to reach the teardrop landmark. Denervation of the articular branches of the Obturator Nerve will be performed in 2 cycles, starting lateral to the lateral edge of the obturator foramen, followed by a point approximately 1cm lateral to the first point. Next, the cannula will be repositioned in a more cranial location, parallel to the superolateral edge of the acetabular dome, to reach the sensory branches of the Femoral Nerve, performing 3 cycles at the 01, 12, and 11 o'clock positions. All lesions will be preceded by motor stimulation at 2,5V and cycles will be followed by the infusion of 2ml of 1% ropivacaine. After concluding the procedure, hip intraarticular infiltration will be performed as described for the control group.
Intraarticular Infiltration ( Control group)Procedure or surgery
For the control group (IA), an epidural anesthesia needle (22G spinal needle) will be used, positioned anteroposteriorly towards the central portion of the femoral neck, which will be introduced until transfixion of the anterior hip capsule through tactile sensitivity. After checking the correct positioning with the use of fluoroscopy and infusion of 3 ml of 50% diluted iodinated contrast, an infusion of 4 ml of 1% Ropivacaine and 80mg of methylprednisolone 40mg/ml will be done.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | This group will be submitted to an intraarticular infiltration of corticosteroid + anesthetic. Receives: Procedure: Intraarticular Infiltration ( Control group) |
| CRF group | Experimental | This group will be submitted to radiofrequency for sensitive hip branches from the Femoral and Obturator nerves followed by an intraarticular infiltration of corticosteroid + anesthetic similar to the control group. Receives: Procedure: Conventional Radiofrequency (CRF group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (WOMAC)
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.
Measured: Baseline to 24 weeks ± 1 week.
Secondary outcomes (6)
Change in Pain Visual Analogue Scale
The pain visual analogue scale (VAS) is a unidimensional measure of pain intensity, in a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme, "no pain" (score 0) and " worst pain ever" (score 100).
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week
Pain Medication Intake
To evaluate pain medication we will use a scale ranging from 0 to 4 (0= no medication; 0 = no medication; 1= use of dipyrone or paracetamol; 2= use of NSAIDs; 3= use of opiate derivatives; 4= routinely scheduled opiate derivatives), considering the last 48 hours.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Isometric Peak Force
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Peak Force of hip flexors, abductors, adductors and extensors.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Average Force
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Average Force of hip flexors, abductors, adductors and extensors. We will also determine intra and inter-rater reliability for isometric force of hip flexors, abductors, adductors and extensors.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Global Satisfaction
To evaluate participant satisfaction, we will use 5 points Likert Scale, ranging from 0 to 4 (0= none _ no good at all, ineffective intervention; 1= poor _ some effect but unsatisfactory; 2= fair _ reasonable effect but could be better; 3= good _ satisfactory effect with occasional episodes of pain or stiffness; 4= excellent _ ideal response, virtually pain-free).
Measured: Time Frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week
Incidence of Adverse Effects
To examine the incidence of adverse effects, a questionnaire will be apply to investigate the occurrence of: Hematoma, paresthesia, weakness, worsening of pain, worsening of function or any other adverse effect that participants attribute to the procedure performed.
Measured: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Sarah Network of Rehabilitation Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221709
- Sponsor's protocol ID
- f3356f
- Status last verified
- Sep 2023
- First submitted
- 14 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identified data will be provided for peer revision in an Open database to allow verification of conclusions as well as inclusion in metanalysis studies.
Publications
Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
PubMed 17964352Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.
PubMed 27286675Pulik L, Romaniuk K, Jaskiewicz K, Wojtynski P, Legosz P, Maldyk P. An update on joint-specific outcome measures in total hip replacement. Reumatologia. 2020;58(2):107-115. doi: 10.5114/reum.2020.95366. Epub 2020 Apr 30.
PubMed 32476684Chye CL, Liang CL, Lu K, Chen YW, Liliang PC. Pulsed radiofrequency treatment of articular branches of femoral and obturator nerves for chronic hip pain. Clin Interv Aging. 2015 Mar 16;10:569-74. doi: 10.2147/CIA.S79961. eCollection 2015.
PubMed 25834413McCabe PS, Maricar N, Parkes MJ, Felson DT, O'Neill TW. The efficacy of intra-articular steroids in hip osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2016 Sep;24(9):1509-17. doi: 10.1016/j.joca.2016.04.018. Epub 2016 Apr 30.
PubMed 27143362Corbett KL, Losina E, Nti AA, Prokopetz JJ, Katz JN. Population-based rates of revision of primary total hip arthroplasty: a systematic review. PLoS One. 2010 Oct 20;5(10):e13520. doi: 10.1371/journal.pone.0013520.
PubMed 20976011Ajrawat P, Radomski L, Bhatia A, Peng P, Nath N, Gandhi R. Radiofrequency Procedures for the Treatment of Symptomatic Knee Osteoarthritis: A Systematic Review. Pain Med. 2020 Feb 1;21(2):333-348. doi: 10.1093/pm/pnz241.
PubMed 31578561Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.
PubMed 31407791Gofeld M, Restrepo-Garces CE, Theodore BR, Faclier G. Pulsed radiofrequency of suprascapular nerve for chronic shoulder pain: a randomized double-blind active placebo-controlled study. Pain Pract. 2013 Feb;13(2):96-103. doi: 10.1111/j.1533-2500.2012.00560.x. Epub 2012 May 4.
PubMed 22554345Kawaguchi M, Hashizume K, Iwata T, Furuya H. Percutaneous radiofrequency lesioning of sensory branches of the obturator and femoral nerves for the treatment of hip joint pain. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):576-81. doi: 10.1053/rapm.2001.26679.
PubMed 11707799Kumar P, Hoydonckx Y, Bhatia A. A Review of Current Denervation Techniques for Chronic Hip Pain: Anatomical and Technical Considerations. Curr Pain Headache Rep. 2019 May 1;23(6):38. doi: 10.1007/s11916-019-0775-z.
PubMed 31044316Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency Procedures to Relieve Chronic Hip Pain: An Evidence-Based Narrative Review. Reg Anesth Pain Med. 2018 Jan;43(1):72-83. doi: 10.1097/AAP.0000000000000694.
PubMed 29140960Rivera F, Mariconda C, Annaratone G. Percutaneous radiofrequency denervation in patients with contraindications for total hip arthroplasty. Orthopedics. 2012 Mar 7;35(3):e302-5. doi: 10.3928/01477447-20120222-19.
PubMed 22385437Vanaclocha-Vanaclocha V, Sáiz-Sapena N, Herrera JM, Rivera-Paz M, Verdú-López F, Renovell-Ferrer P, et al. Cronicon EC ORTHOPAEDICS Clinical Study Percutaneous Radiofrequency Denervation in the Treatment of Hip Pain Secondary to Osteoarthritis. n.d.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jeric K, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials DEVELOPMENT OF THE SPIRIT 2013 STATEMENT. vol. 158. 2013.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Radiofrequency in Hip Osteoarthritis Pain: A Protocol of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06221709
- Acronym / sponsor ID
- f3356f
- Conditions
- Hip Osteoarthritis, Hip Pain Chronic
- Keywords
- denervation, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Sarah Network of Rehabilitation Hospitals
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Jan 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.
This will be a prospective, single-center, double-blinded, randomized study designed to compare the efficacy of the intraarticular injection of a corticosteroid and the Conventional Radiofrequency (CRF) of the anterior sensory branches to the hip in controlling pain and improving function related to hip osteoarthritis.
Detailed description
Procedures will be performed in the surgical block of Hospital SARAH, Brasília unit, using an aseptic technique.
All participants will undergo sedation or general anesthesia using a laryngeal mask airway, according to the preference of the anesthetist in the room. The procedure will be performed with the participant positioned in dorsal decubitus, on a radiolucent table, with a small pillow below the knees to promote a slight flexion of 10 to 20 degrees of the hips, leading to relaxation of the joint capsule.
The surgeon will be positioned at the side of the surgical table, facing the affected hip, with the scoping device on the contralateral side, aligned at 90 degrees with the patient, allowing the visualization of anteroposterior images of the affected hip.
For the control group (IAI), a 22G spinal needle will be used, positioned in the anteroposterior direction towards the central portion of the femoral neck, which will be introduced until it trespasses the anterior hip capsule through tactile sensitivity. After verifying the correct positioning with the use of fluoroscopy and infusion of 3 milliliters (ml) of iodinated contrast diluted at 50% (Iomeron® 300, Patheon Italia S.p.A. Ferentino - Italy), an infiltration of 4 ml of 1% Ropivacaine (Ropi®, Cristália, Itapira - São Paulo, Brazil) and 80mg of methylprednisolone 40mg/ml (Predi-Medrol®, União Química, Brasília - Federal District, Brazil) will be performed, totalizing 6 ml of solution.
In the intervention group (IA + CRF), radiofrequency ablation will be performed with the aid of a 22-gauge cannula (Diros Technology Inc, Markham, Ontario, Canada), 10 or 15 cm long, with a 10-mm curved active tip, at a temperature of 90º for 90 seconds. The cannula will be introduced in the region just above the tip of the greater trochanter, lateral to a descending line originating in the anterior superior iliac spine (ASIS), and directed to the medial border of the patella (ASIS - patella). Its introduction will take place in the anteroposterior and lateromedial direction, to reach the region lateral to the anatomical reference known as the teardrop, with an angle of about 20 to 30 craniocaudal degrees about a transverse line on the axis of the thigh. The denervation of the articular branches of the Obturator Nerve (NO) will be performed in 2 cycles, at a temperature of 90 degrees for 90 seconds, starting lateral to the lateral edge of the obturator foramen and inferior to the teardrop, with subsequent repositioning of the cannula about 1 cm lateral to the first point. Both lesions will be preceded by motor stimulation at 2.5 volts (V) to exclude motor branches within the range of action of the active tip followed by the infusion of 2ml of 1% ropivacaine. Then, the cannula will be repositioned in a more cranial location, 2 to 3 cm lateral to the ASIS-patella line, parallel to the superolateral edge of the acetabular dome, to reach the sensory branches of the Femoral Nerve (NF), performing three cycles (from medial to lateral) at the 01, 12, and 11 o'clock positions. The most medial lesion will be preceded by motor stimulation at 2.5 V to exclude motor branches within the active tip's range of action. All three cycles will be followed by 2 ml of 1% ropivacaine infusion. After completion of radiofrequency ablation, IAI of the hip will follow as described for the control group above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Intraarticular Infiltration ( Control group)This group will be submitted to an intraarticular infiltration of corticosteroid + anesthetic. |
| CRF group | Experimental | Procedure: Conventional Radiofrequency (CRF group)This group will be submitted to radiofrequency for sensitive hip branches from the Femoral and Obturator nerves followed by an intraarticular infiltration of corticosteroid + anesthetic similar to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals ≥ 18 years of age, with symptomatic unilateral hip osteoarthritis, grades II and III according to the Kellgreen and Lawrance classification, hip pain for more than six months (medial, anterior, anterolateral, and/or lateral region) will be included.
Key exclusion criteria (1 listed)
- Individuals with radiculopathy and ipsilateral irradiation, osteonecrosis of the femoral head, previous arthroplasty on the hip to be studied or surgical scar that could lead to changes in the anatomy of the hip, cases of high dislocation of the hip, pain exclusively in the posterior region, symptomatic ipsilateral knee osteoarthritis, intra-articular infiltration of corticosteroids or hyaluronic acid in the hip for less than six months, patients with neurological diseases, peripheral neuropathy or psychiatric diseases, use of a pacemaker or Prothrombin Activity Time (INR) > 3.
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 |
|---|---|---|
| Conventional Radiofrequency (CRF group)Also: RadioablationRadiofrequency will be performed with a 22-gauge CRF cannula, 10/15 cm long, 10mm curved active tip, at 90º for 90 seconds, introduced in the anteroposterior and lateromedial directions, to reach the teardrop landmark. Denervation of the articular branches of the Obturator Nerve will be performed in 2 cycles, starting lateral to the lateral edge of the obturator foramen, followed by a point approximately 1cm lateral to the first point. Next, the cannula will be repositioned in a more cranial location, parallel to the superolateral edge of the acetabular dome, to reach the sensory branches of the Femoral Nerve, performing 3 cycles at the 01, 12, and 11 o'clock positions. All lesions will be preceded by motor stimulation at 2,5V and cycles will be followed by the infusion of 2ml of 1% ropivacaine. After concluding the procedure, hip intraarticular infiltration will be performed as described for the control group. | Procedure or surgery | CRF group |
| Intraarticular Infiltration ( Control group)For the control group (IA), an epidural anesthesia needle (22G spinal needle) will be used, positioned anteroposteriorly towards the central portion of the femoral neck, which will be introduced until transfixion of the anterior hip capsule through tactile sensitivity. After checking the correct positioning with the use of fluoroscopy and infusion of 3 ml of 50% diluted iodinated contrast, an infusion of 4 ml of 1% Ropivacaine and 80mg of methylprednisolone 40mg/ml will be done. | Procedure or surgery | Control Group |
Primary outcome
Quality of Life (WOMAC)
Time frame: Baseline to 24 weeks ± 1 week.
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.
6 secondary outcomes
Change in Pain Visual Analogue Scale
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week
Pain Medication Intake
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Isometric Peak Force
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Average Force
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Global Satisfaction
Time frame: Time Frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week
Incidence of Adverse Effects
Time frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
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 24 Jan 2024.
- Background: PubMed 17964352Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
- Background: PubMed 27286675Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.
- Background: PubMed 32476684Pulik L, Romaniuk K, Jaskiewicz K, Wojtynski P, Legosz P, Maldyk P. An update on joint-specific outcome measures in total hip replacement. Reumatologia. 2020;58(2):107-115. doi: 10.5114/reum.2020.95366. Epub 2020 Apr 30.
- Background: PubMed 25834413Chye CL, Liang CL, Lu K, Chen YW, Liliang PC. Pulsed radiofrequency treatment of articular branches of femoral and obturator nerves for chronic hip pain. Clin Interv Aging. 2015 Mar 16;10:569-74. doi: 10.2147/CIA.S79961. eCollection 2015.
- Background: PubMed 27143362McCabe PS, Maricar N, Parkes MJ, Felson DT, O'Neill TW. The efficacy of intra-articular steroids in hip osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2016 Sep;24(9):1509-17. doi: 10.1016/j.joca.2016.04.018. Epub 2016 Apr 30.
- Background: PubMed 20976011Corbett KL, Losina E, Nti AA, Prokopetz JJ, Katz JN. Population-based rates of revision of primary total hip arthroplasty: a systematic review. PLoS One. 2010 Oct 20;5(10):e13520. doi: 10.1371/journal.pone.0013520.
- Background: PubMed 31578561Ajrawat P, Radomski L, Bhatia A, Peng P, Nath N, Gandhi R. Radiofrequency Procedures for the Treatment of Symptomatic Knee Osteoarthritis: A Systematic Review. Pain Med. 2020 Feb 1;21(2):333-348. doi: 10.1093/pm/pnz241.
- Background: PubMed 31407791Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.
- Background: PubMed 22554345Gofeld M, Restrepo-Garces CE, Theodore BR, Faclier G. Pulsed radiofrequency of suprascapular nerve for chronic shoulder pain: a randomized double-blind active placebo-controlled study. Pain Pract. 2013 Feb;13(2):96-103. doi: 10.1111/j.1533-2500.2012.00560.x. Epub 2012 May 4.
- Background: PubMed 11707799Kawaguchi M, Hashizume K, Iwata T, Furuya H. Percutaneous radiofrequency lesioning of sensory branches of the obturator and femoral nerves for the treatment of hip joint pain. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):576-81. doi: 10.1053/rapm.2001.26679.
- Background: PubMed 31044316Kumar P, Hoydonckx Y, Bhatia A. A Review of Current Denervation Techniques for Chronic Hip Pain: Anatomical and Technical Considerations. Curr Pain Headache Rep. 2019 May 1;23(6):38. doi: 10.1007/s11916-019-0775-z.
- Background: PubMed 29140960Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency Procedures to Relieve Chronic Hip Pain: An Evidence-Based Narrative Review. Reg Anesth Pain Med. 2018 Jan;43(1):72-83. doi: 10.1097/AAP.0000000000000694.
- Individual participant dataSharing planned: Yes. Non-identified data will be provided for peer revision in an Open database to allow verification of conclusions as well as inclusion in metanalysis studies.
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Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Radiofrequency (CRF group) in people with Hip Osteoarthritis and Hip Pain Chronic, run by University of Brasilia at 1 site in Brazil.
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 1 inclusion and 1 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 24 Jan 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 Brazil. 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?
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 Gilvan F Vaz, MD (5561991527220, gilvanvaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (WOMAC) (time frame: Baseline to 24 weeks ± 1 week.). 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 NCT06221709, which also lists 30 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 24 Jan 2024.