Radiofrequency Versus Intraarticular Local Anesthestic and Steroids Injection for Chronic Hip Pain.
Unknown statusPhase 4NCT03985280
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Pilot, prospective, randomized study to compare the effectiveness of two techniques against chronic hip pain :cooled radiofrequency on sensory innervation of the hip and intra-articular infiltration of local anesthetic and corticoid. EudraCT protocol code. 2018-000269-36 Promoter / Principal Investigator. Jorge Orduña Valls Name of the person responsible for the monitoring: Nativity Well of the Rose. Design. Pilot, prospective, randomized study to compare the effectiveness of two techniques against chronic pain of hip: radiofrequency cooled on sensory innervation of the hip and intra-articular infiltration of local anesthetic and corticoid. Phase of the trial. Phase IV, efficacy evaluation with respect to standard treatment. Conditions to study. Percentage of subjects with VAS reduction greater than 50% compared to baseline at three months after application of the technique in the two treatment groups. Longer duration of the analgesic effect (defined as a reduction of the VAS greater than 50% basal) at six months from the application of the technique in patients with hip pain. Intervention. Application of radiofrequency cooled on nerve endings of the hip. The standard treatment Non-surgical consists of intra-articular injection of local anesthetic and corticoid. Main and secondary objective. Main goal: * Percentage of subjects with improvement in the two groups defined as VAS reduction greater than 50% with respect to the baseline after three months from the application of the technique. * Compare the persistence of the clinical effect in terms of pain reduction (quantified by a reduction of 50% in the VAS scale compared to the baseline) after six months after the application of the Radiofrequency cooled on sensitive nerve branches of the hip compared to intra-articular injection of local anesthetic and corticoid. Secondary objectives: * Compare the improvement of functional capacity of patients submitted to radiofrequency cooled compared to those treated by intra-a…
Study details
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of Two Techniques Against Hip Pain: Cooled Radiofrequency , Compared to Intraarticular Injection.
- Conditions
- Interventions
- Device: Cooled radiofrequency
- Drug: Intraaticular steroids and local anesthetic injections
- Sponsor
- Jorge Orduña-Valls
- Organization
- Hospital Clínico Universitario de Valencia
- Start date
- 2018-06-21
- Primary completion
- 2020-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient over 18 years old. * Chronic hip pain (more than 3 months) that has not responded to conservative treatment, therapy pharmacological, physiotherapy or TENS). * Mechanical pain in the affected limb with a VAS of at least 50 mm during the ambulation * Patients for whom it is possible to carry out all the scheduled visits of the study, with capacity for go in the established deadlines to the control visits. * Greater than 50% improvement in the VAS scale after the two anesthetic blocks made with anesthetics local of different duration (bupivacaine 0.25% and mepivacaine 2%) * Moderate to severe osteoarthrosis determined with grades Kellgren-Lawrence II, III, IV. * Stable doses of analgesics for at least 30 days before starting the study. * Patients who have performed the Oxford Hip Score and WOMAC test 3 months or less before the study. * Absence of allergy or adverse events known to any of the medications administered: local anesthetics of amide group and iodinated contrasts. -Negative pregnancy test (women of childbearing age) and commitment to guarantee contraception during the study Exclusion Criteria: * Signs of alarm or infection in the joint affects. * Signs of active infection, immunosuppression or active HIV. * Severe psychiatric diseases. * Patient with hip prosthesis. * Pain added to an unexplained weight loss of more than 5% 90 days or less before the beginning of the study. * Pain of root origin established in the affected limb, or neurodegenerative diseases of the Peripheral nervous system. * Patients with basic tumor pathology or who have had cancer in the five years prior to the inclusion. * Alterations of the coagulation or taking of anticoagulants / antiaggregants (except aspirin 150 or 300) mg / day) at the beginning of the study, which can not be suspended for basic pathology during an interval prudent for the realization of the technique. * Patient that has participated in a clinical study the previous 30 days in which they are performed interventions that may affect the results of the study. * Patient with a diagnosis of disorder due to substance abuse or alcoholism. * Patient who is in process for the award of a disability or degree of disability. * Pregnant or lactating patient. * Patient under treatment with opioids with doses greater than the equivalent to 90 milligrams of oral morphine / day.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03985280