Continuous Radiofrequency in Hip Osteoarthritis Pain: A Randomized Clinical Trial.

Launched by UNIVERSITY OF BRASILIA · Jan 14, 2024

Nctid: NCT06221709

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D010003", "term"=>"Osteoarthritis"}, {"id"=>"D015207", "term"=>"Osteoarthritis, Hip"}], "ancestors"=>[{"id"=>"D001168", "term"=>"Arthritis"}, {"id"=>"D007592", "term"=>"Joint Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M17912", "name"=>"Osteoarthritis, Hip", "asFound"=>"Hip Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M11749", "name"=>"Methylprednisolone", "relevance"=>"LOW"}, {"id"=>"M1833", "name"=>"Methylprednisolone Acetate", "relevance"=>"LOW"}, {"id"=>"M11750", "name"=>"Methylprednisolone Hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M14120", "name"=>"Prednisolone", "relevance"=>"LOW"}, {"id"=>"M229449", "name"=>"Prednisolone acetate", "relevance"=>"LOW"}, {"id"=>"M211887", "name"=>"Prednisolone hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M248881", "name"=>"Prednisolone phosphate", "relevance"=>"LOW"}, {"id"=>"M1700", "name"=>"Ropivacaine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"All participants will be blinded to which group they will be allocated, as well as data assessors, who will not have contact with participants on the day of the procedure. In order to avoid differentiating the number of perforations needed to perform each procedure, all patients will receive the same bandage (Opsite®) in the anterior region of the hip, with instruction to remove it only the day after the procedure."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>70}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-09", "completionDateStruct"=>{"date"=>"2027-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-14", "studyFirstSubmitDate"=>"2024-01-14", "studyFirstSubmitQcDate"=>"2024-01-14", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Quality of Life (WOMAC)", "timeFrame"=>"Baseline to 24 weeks ± 1 week.", "description"=>"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."}], "secondaryOutcomes"=>[{"measure"=>"Change in Pain Visual Analogue Scale", "timeFrame"=>"Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week", "description"=>"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)."}, {"measure"=>"Pain Medication Intake", "timeFrame"=>"Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.", "description"=>"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."}, {"measure"=>"Change in Hip muscles Isometric Peak Force", "timeFrame"=>"Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.", "description"=>"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."}, {"measure"=>"Change in Hip muscles Average Force", "timeFrame"=>"Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.", "description"=>"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."}, {"measure"=>"Change in Global Satisfaction", "timeFrame"=>"Time Frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week", "description"=>"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)."}, {"measure"=>"Incidence of Adverse Effects", "timeFrame"=>"1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.", "description"=>"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."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["denervation", "Radiofrequency ablation"], "conditions"=>["Hip Osteoarthritis", "Hip Pain Chronic"]}, "referencesModule"=>{"references"=>[{"pmid"=>"17964352", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"27286675", "type"=>"BACKGROUND", "citation"=>"Singh 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."}, {"pmid"=>"32476684", "type"=>"BACKGROUND", "citation"=>"Pulik 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."}, {"pmid"=>"25834413", "type"=>"BACKGROUND", "citation"=>"Chye CL, Liang CL, Lu K, Chen YW, Liliang PC. Pulsed radiofrequency treatment of articular branches of femoral and obturator nerves for chronic hip pain. 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Reg Anesth Pain Med. 2001 Nov-Dec;26(6):576-81. doi: 10.1053/rapm.2001.26679."}, {"pmid"=>"31044316", "type"=>"BACKGROUND", "citation"=>"Kumar 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. Erratum In: Curr Pain Headache Rep. 2019 May 28;23(6):45. doi: 10.1007/s11916-019-0807-8."}, {"pmid"=>"29140960", "type"=>"BACKGROUND", "citation"=>"Bhatia 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."}, {"pmid"=>"22385437", "type"=>"BACKGROUND", "citation"=>"Rivera F, Mariconda C, Annaratone G. Percutaneous radiofrequency denervation in patients with contraindications for total hip arthroplasty. 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PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015."}, {"pmid"=>"29071305", "type"=>"BACKGROUND", "citation"=>"Chamorro C, Armijo-Olivo S, De la Fuente C, Fuentes J, Javier Chirosa L. Absolute Reliability and Concurrent Validity of Hand Held Dynamometry and Isokinetic Dynamometry in the Hip, Knee and Ankle Joint: Systematic Review and Meta-analysis. Open Med (Wars). 2017 Oct 17;12:359-375. doi: 10.1515/med-2017-0052. eCollection 2017."}, {"pmid"=>"9463853", "type"=>"BACKGROUND", "citation"=>"Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e."}, {"pmid"=>"30045597", "type"=>"BACKGROUND", "citation"=>"Tinnirello A, Todeschini M, Pezzola D, Barbieri S. Pulsed Radiofrequency Application on Femoral and Obturator Nerves for Hip Joint Pain: Retrospective Analysis with 12-Month Follow-up Results. Pain Physician. 2018 Jul;21(4):407-414."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"Procedures will be performed in the surgical block of Hospital SARAH, Brasília unit, using an aseptic technique.\n\nAll 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.\n\nThe 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.\n\nFor 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.\n\nIn 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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."}, "identificationModule"=>{"nctId"=>"NCT06221709", "briefTitle"=>"Continuous Radiofrequency in Hip Osteoarthritis Pain: A Randomized Clinical Trial.", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Brasilia"}, "officialTitle"=>"Continuous Radiofrequency in Hip Osteoarthritis Pain: A Protocol of a Randomized Clinical Trial", "orgStudyIdInfo"=>{"id"=>"f3356f"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Control Group", "description"=>"This group will be submitted to an intraarticular infiltration of corticosteroid + anesthetic.", "interventionNames"=>["Procedure: Intraarticular Infiltration ( Control group)"]}, {"type"=>"EXPERIMENTAL", "label"=>"CRF group", "description"=>"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.", "interventionNames"=>["Procedure: Conventional Radiofrequency (CRF group)"]}], "interventions"=>[{"name"=>"Conventional Radiofrequency (CRF group)", "type"=>"PROCEDURE", "otherNames"=>["Radioablation"], "description"=>"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.", "armGroupLabels"=>["CRF group"]}, {"name"=>"Intraarticular Infiltration ( Control group)", "type"=>"PROCEDURE", "description"=>"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.", "armGroupLabels"=>["Control Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"70335901", "city"=>"Brasília", "state"=>"Distrito Federal", "status"=>"RECRUITING", "country"=>"Brazil", "contacts"=>[{"name"=>"Gilvan F Vaz, MD", "role"=>"CONTACT", "email"=>"gilvanvaz@gmail.com", "phone"=>"+5561991527220"}, {"name"=>"Joao M Montecchi, MD", "role"=>"CONTACT", "email"=>"jmontecchi@gmail.com", "phone"=>"5511944471992"}, {"name"=>"João S Durigan, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Rede Sarah Hospitais de Reabilitação", "geoPoint"=>{"lat"=>-15.77972, "lon"=>-47.92972}}], "centralContacts"=>[{"name"=>"Gilvan F Vaz, MD", "role"=>"CONTACT", "email"=>"gilvanvaz@gmail.com", "phone"=>"5561991527220"}, {"name"=>"João M Montecchi, MD", "role"=>"CONTACT", "email"=>"jmontecchi@gmail.com", "phone"=>"+5511944471992"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "CSR"], "timeFrame"=>"Data will be available at the moment of publication of the final paper.", "ipdSharing"=>"YES", "description"=>"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.", "accessCriteria"=>"Open access."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Brasilia", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Sarah Network of Rehabilitation Hospitals", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}