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Clinical Trials/EUCTR2018-000269-36-ES
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

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.

Registry
who.int
Start Date
April 9, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
JORGE ORDUÑA VALLS

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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