NCT03985280: HIPAIN

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

Status unknown Phase 4 Last updated 13 June 2019

What this trial tests

Phase 4 trial testing Cooled radiofrequency in Hip Pain Chronic in 20 participants. Status unknown.

Timeline

21 June 2018

Primary endpoint
30 June 2020

30 July 2021

Quick facts

Lead sponsor	Jorge Orduña-Valls
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	21 June 2018
Primary completion	30 June 2020
Estimated completion	30 July 2021
Sites	1 location across Spain

Drugs / interventions tested

• Cooled radiofrequency
• Intraaticular steroids and local anesthetic injections — full drug profile →

Conditions studied

• Hip Pain Chronic — all drugs for Hip Pain Chronic →

Sponsor

Jorge Orduña-Valls — full company profile →

Who can join

18 and older, any sex, with Hip Pain Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.