Chronic Hip Pain by Osteoarthrosis
Conditions
Interventions
Trade Name: TRIGON DEPOT
Product Name: triamcinolone acetonide
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS Number: 76-25-5
Concentration unit:
Sponsors
JORGE ORDUÑA VALLS
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 638/5000 - To compare the improvement of the functional capacity of patients subjected to radiofrequency cooled compared to those treated by intra-articular injection of local anesthetic and corticosteroid measured by the WOMAC and Oxford Hip score scales. -Compare the duration of the clinical improvement in terms of pain reduction quantified by the VAS scale (visual analog scale) a year after the application of both techniques. - To compare the improvement of the quality of life of patients subjected to cooled radiofrequency compared to those treated by intra-articular injection of local anesthetic and corticosteroid as measured by the SF 36 scale.;Primary end point(s): a)-Improvement more than 50% in VAS score in patients under treatment with Intraarticular injection or cooled radiofrequency b)-Duration of the clinical effect in terms of pain reduction (quantified by a 50% reduction in the VAS scale with respect to the baseline level) ;Timepoint(s) of evaluation of this end point: a)-3 months b)-6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Compare the improvement of the functional capacity of patients subjected to radiofrequency cooled compared to those treated by intra-articular injection of local anesthetic and corticosteroid measured by the WOMAC and Oxford Hip score scales. -Compare the duration of the clinical improvement in terms of pain reduction quantified by the VAS scale (visual analog scale) a year after the application of both techniques. - To compare the improvement of the quality of life of patients subjected to cooled radiofrequency compared to those treated by intra-articular injection of local anesthetic and corticosteroid as measured by the SF 36 scale.;Timepoint(s) of evaluation of this end point: -One month from treatments day. -Thee months from treatments day. -Six Months from treatments day. -12 Months from treatments day. -24 Months from treatments day. | — |
Countries
Spain
Contacts
Public ContactJORGE ORDUNA
INCLIVA
Outcome results
None listed