Randomized study to evaluate the efficacy of two techniques against chronic hip pain: radiofrequency over sensitive nerves of the hip, compared injection of steroids and local anestethic into the hip.

Phase 1

• Conditions: Chronic Hip Pain by Osteoarthrosis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-000269-36-ES
• Lead Sponsor: JORGE ORDUÑA VALLS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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

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.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified