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临床试验/EUCTR2018-000269-36-ES
EUCTR2018-000269-36-ES进行中(未招募)1 期

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 个研究点目标入组 20 人开始时间: 2018年4月9日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 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.
  • 11- Patient who is in process for the award of a disability or degree of disability.
  • 12- Pregnant or lactating patient.
  • 13- Patient under treatment with opioids with doses greater than the equivalent to 90 milligrams of oral morphine / day.

研究者

发起方
JORGE ORDUÑA VALLS

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