Hip Pain Chronic Clinical Trial
Official title:
Randomized Clinical Trial to Evaluate the Efficacy of Two Techniques Against Hip Pain: Cooled Radiofrequency , Compared to Intraarticular Injection.
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
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.
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.
;
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