EUCTR2018-000269-36-ES
Active, not recruiting
Phase 1
Randomized clinical trial to evaluate the efficacy of two techniques against chronic hip pain: cooled radiofrequency over sensitive nerves of the hip, compared to intraarticular injection of steroids and local anestethic under fluoroscopic guidance on the hip. - Randomized trial: radiofrequency versus intraarticular local anesthestic and steroids.
JORGE ORDUÑA VALLS0 sites20 target enrollmentApril 9, 2018
ConditionsChronic Hip Pain by OsteoarthrosisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsTRIGON DEPOT
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Hip Pain by Osteoarthrosis
- Sponsor
- JORGE ORDUÑA VALLS
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\- Patient over 18 years old.
- •2\- Chronic hip pain (more than 3 months) that has not responded to conservative treatment, pharmacological therapy, physiotherapy or TENS).
- •3\- Mechanical pain in the affected limb with a VAS of at least 50 mm during ambulation.
- •4\- Patients for whom it is possible to carry out all the scheduled visits of the study, with the capacity to attend within the established deadlines for the control visits.
- •5\- Greater than 50% improvement in the VAS scale after the two anesthetic blocks performed with local anesthetics of different duration (levobupivacaine 0\.25% and mepivacaine 2%)
- •6\- Moderate to severe osteoarthrosis determined with degrees Kellgren\-Lawrence II, III, IV.
- •7\- Stable doses of analgesics at least 30 days before starting the study.
- •8\- Patients who have performed the Oxford Hip Score and WOMAC test 3 months or less before the study.
- •9\- Absence of allergy or adverse events known to any of the medications administered: local anesthetics of amide group and iodinated contrasts.
- •10\-Negative pregnancy test (women of childbearing age) and commitment to guarantee contraception during the study
Exclusion Criteria
- •1\- Signs of alarm or infection in the joint affects.
- •2\- Signs of active infection, immunosuppression or active HIV.
- •3\- Severe psychiatric illnesses.
- •4\-Patient carrier of hip prosthesis.
- •5\- Pain added to an unexplained weight loss of more than 5% 90 days or less before the start of the study.
- •6\- Pain of root origin established in the affected limb, or neurodegenerative diseases of the peripheral nervous system.
- •7\- Patients with basic tumor pathology or who have had cancer in the five years prior to inclusion.
- •8\- 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 a prudent interval for the realization of the technique.
- •9\- Patient who has participated in a clinical study for the previous 30 days in which interventions are performed that may affect the results of the study.
- •10\- Patient with a diagnosis of disorder due to substance abuse or alcoholism.
Outcomes
Primary Outcomes
Not specified
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