Radiofrequency Versus Intraarticular Local Anesthestic and Steroids Injection for Chronic Hip Pain.

Summary

Pilot, prospective, randomized study to compare the effectiveness of two techniques against chronic hip pain :cooled radiofrequency on sensory innervation of the hip and intra-articular infiltration of local anesthetic and corticoid.

EudraCT protocol code. 2018-000269-36

Promoter / Principal Investigator. Jorge Orduña Valls

Name of the person responsible for the monitoring:

Nativity Well of the Rose.

Design. Pilot, prospective, randomized study to compare the effectiveness of two techniques against chronic pain of hip: radiofrequency cooled on sensory innervation of the hip and intra-articular infiltration of local anesthetic and corticoid.

Phase of the trial. Phase IV, efficacy evaluation with respect to standard treatment.

Conditions to study. Percentage of subjects with VAS reduction greater than 50% compared to baseline at three months after application of the technique in the two treatment groups.

Longer duration of the analgesic effect (defined as a reduction of the VAS greater than 50% basal) at six months from the application of the technique in patients with hip pain.

Intervention. Application of radiofrequency cooled on nerve endings of the hip. The standard treatment Non-surgical consists of intra-articular injection of local anesthetic and corticoid.

Main and secondary objective.

Main goal:

* Percentage of subjects with improvement in the two groups defined as VAS reduction greater than 50% with respect to the baseline after three months from the application of the technique.
* Compare the persistence of the clinical effect in terms of pain reduction (quantified by a reduction of 50% in the VAS scale compared to the baseline) after six months after the application of the Radiofrequency cooled on sensitive nerve branches of the hip compared to intra-articular injection of local anesthetic and corticoid.

Secondary objectives:

* Compare the improvement of functional capacity of patients submitted 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 scale VAS (analog visual scale) per year after the application of both techniques.
* To compare the improvement of the quality of life of patients subjected to radiofrequency cooled with respect to those treated by intra-articular injection of local anesthetic and corticosteroid measured by the SF 36 scale.

Main valuation variable.

Main variable:

The evaluation of pain by means of the Visual analogic scale (VAS) A significant reduction in pain will be considered when VAS decreases by\> 50% of the baseline value.

Secondary variables:

* Functional improvement valued by the scales: Oxford Hip score, WOMAC
* Better of the quality of life valued by the SF 36 scale
* The duration of the clinical effect by means of the duration of improvement of the VAS scale.

Population under study and total number of patients. Adult patients with chronic hip pain greater than three months who has not responded to treatment conservative and that is not subsidiary of surgery either by the evolutionary stage or by contraindications related to morbidity terms.

Period of follow-up. The duration of the intervention is 12 months from randomization. After the scheduled interventions, patients will be scheduled for monthly follow-up, three, six and twelve months after the procedure

Conditions

• Hip Pain Chronic

Interventions

DEVICE

Cooled radiofrequency

Under guidance of combined X-ray and ultrasound the nerves will be located . After local anesthetic aplication cooled RF needle will be apply in the objective position. Cooled RF will be performed for 2:30 minutes at 60 º C degrees.

DRUG

Intraaticular steroids and local anesthetic injections

Intraaticular steroids and local anesthetic injections

Sponsors & Collaborators

• Jorge Orduña-Valls

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-21

Primary Completion

2020-06-30

Completion

2021-07-30

Countries

• Spain

Study Locations