Hip Pain ChronicPhase 4HIPAINNCT03985280
Radiofrequency Versus Intraarticular Local Anesthestic and Steroids Injection for Chronic Hip Pain.
A Phase 4 study testing Cooled radiofrequency and Intraaticular steroids and local anesthetic injections in people with Hip Pain Chronic, run by Jorge Orduña-Valls at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Pain Chronic
- What is being tested?
- Cooled radiofrequency and Intraaticular steroids and local anesthetic injections
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jun 2018to 30 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old.
- Chronic hip pain (more than 3 months) that has not responded to conservative treatment, therapy pharmacological, physiotherapy or TENS).
- Mechanical pain in the affected limb with a VAS of at least 50 mm during the ambulation
- Patients for whom it is possible to carry out all the scheduled visits of the study, with capacity for go in the established deadlines to the control visits.
- Greater than 50% improvement in the VAS scale after the two anesthetic blocks made with anesthetics local of different duration (bupivacaine 0.25% and mepivacaine 2%)
- Moderate to severe osteoarthrosis determined with grades Kellgren-Lawrence II, III, IV.
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- Stable doses of analgesics for at least 30 days before starting the study.
- Patients who have performed the Oxford Hip Score and WOMAC test 3 months or less before the study.
- Absence of allergy or adverse events known to any of the medications administered:
- local anesthetics of amide group and iodinated contrasts.
- -Negative pregnancy test (women of childbearing age) and commitment to guarantee contraception during the study
Who cannot join
- Signs of alarm or infection in the joint affects.
- Signs of active infection, immunosuppression or active HIV.
- Severe psychiatric diseases.
- Patient with hip prosthesis.
- Pain added to an unexplained weight loss of more than 5% 90 days or less before the beginning of the study.
- Pain of root origin established in the affected limb, or neurodegenerative diseases of the Peripheral nervous system.
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- Patients with basic tumor pathology or who have had cancer in the five years prior to the inclusion.
- 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 an interval prudent for the realization of the technique.
- Patient that has participated in a clinical study the previous 30 days in which they are performed interventions that may affect the results of the study.
- Patient with a diagnosis of disorder due to substance abuse or alcoholism.
- Patient who is in process for the award of a disability or degree of disability.
- Pregnant or lactating patient.
- Patient under treatment with opioids with doses greater than the equivalent to 90 milligrams of oral morphine / day.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital clinico universitario de Valencia
Valencia, Valencia, 46010
Jorge Orduña, MD, 00346664422436, dr.orduna.dolor@gmail.com
About this study
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
Read more
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
Read the detailed 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.
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.
- Conditions
- Hip Pain Chronic
- Being tested
- Cooled radiofrequency, Intraaticular steroids and local anesthetic injections
- Keywords
- Cooled radiofrequency, Radiofrequency, Hip pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled radiofrequencyDevice
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.
Intraaticular steroids and local anesthetic injectionsDrug
Intraaticular steroids and local anesthetic injections
| Study group | Role | What they receive |
|---|---|---|
| Cooled radiofrequency | Experimental | The procedure will be performed under regimen of major ambulatory surgery, it will be done under guidance of combined X-ray and ultrasound. . The nerves will be located b, after applying AL (Lidocaine 1%), a RF needle will be placed in the objective position.After verifying the positive sensitive and negative motor responses the cooled radiofrequency will proceed (previous application of local anesthesia (lidocaine 2%)). Cooled RF will be performed for 2:30 minutes at 60 degrees. Receives: Device: Cooled radiofrequency |
| Intraarticular local anesthetic and steroids injections | Active comparator | An intraarticular injection will be done in ambulatory surgery regimen with a 22 Gauge needle. Intraarticular injection will be done under Fluoroscopic guidance (X-rays) with intra articular position confirmation by infusion of iodine contrast (Omnipaque 240). Once the needle position has been verified we will administer 10 mg of bipuvacaine, and 40 mg triamcinolone hexacetonide. Receives: Drug: Intraaticular steroids and local anesthetic injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Percentage of subjects with improvement measured by VAS after three months. -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
VAS --- 100 the most , 0 the less
Measured: 3 months
Secondary outcomes (4)
-Compare the improvement of functional capacity measured by the WOMAC.
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68
Measured: 12 months
-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.
VAS (analog visual scale)-- 0 the worst, 100 the best
Measured: 12 months
- 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.
SF 36 scale. 1 the best, 5 the worst
Measured: 12 months
-Compare the improvement of functional capacity measured by the Oxford Hip score .
12 questions--- 40-48 pints --May indicate satisfactory joint function. May not require any formal treatment.
Score 0 to 19--May indicate severe hip arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start21 Jun 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorge Orduña-Valls
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Orduña-Valls, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985280
- Sponsor's protocol ID
- HIPAIN
- Acronym
- HIPAIN
- Status last verified
- Jun 2019
- First submitted
- 25 Feb 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of Two Techniques Against Hip Pain: Cooled Radiofrequency , Compared to Intraarticular Injection.
- ClinicalTrials.gov ID
- NCT03985280
- Acronym / sponsor ID
- HIPAIN / HIPAIN
- Conditions
- Hip Pain Chronic
- Keywords
- Cooled radiofrequency, Radiofrequency, Hip pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jorge Orduña-VallsUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooled radiofrequency | Experimental | Device: Cooled radiofrequencyThe procedure will be performed under regimen of major ambulatory surgery, it will be done under guidance of combined X-ray and ultrasound. . The nerves will be located b, after applying AL (Lidocaine 1%), a RF needle will be placed in the objective position.After verifying the positive sensitive and negative motor responses the cooled radiofrequency will proceed (previous application of local anesthesia (lidocaine 2%)). Cooled RF will be performed for 2:30 minutes at 60 degrees. |
| Intraarticular local anesthetic and steroids injections | Active comparator | Drug: Intraaticular steroids and local anesthetic injectionsAn intraarticular injection will be done in ambulatory surgery regimen with a 22 Gauge needle. Intraarticular injection will be done under Fluoroscopic guidance (X-rays) with intra articular position confirmation by infusion of iodine contrast (Omnipaque 240). Once the needle position has been verified we will administer 10 mg of bipuvacaine, and 40 mg triamcinolone hexacetonide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient over 18 years old.
- Chronic hip pain (more than 3 months) that has not responded to conservative treatment, therapy pharmacological, physiotherapy or TENS).
- Mechanical pain in the affected limb with a VAS of at least 50 mm during the ambulation
- Patients for whom it is possible to carry out all the scheduled visits of the study, with capacity for go in the established deadlines to the control visits.
- Greater than 50% improvement in the VAS scale after the two anesthetic blocks made with anesthetics local of different duration (bupivacaine 0.25% and mepivacaine 2%)
Key exclusion criteria (13 listed)
- Signs of alarm or infection in the joint affects.
- Signs of active infection, immunosuppression or active HIV.
- Severe psychiatric diseases.
- Patient with hip prosthesis.
- Pain added to an unexplained weight loss of more than 5% 90 days or less before the beginning of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooled radiofrequencyUnder 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. | Device | Cooled radiofrequency |
| Intraaticular steroids and local anesthetic injectionsIntraaticular steroids and local anesthetic injections | Drug | Intraarticular local anesthetic and steroids injections |
Primary outcome
- Percentage of subjects with improvement measured by VAS after three months. -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
Time frame: 3 months
VAS --- 100 the most , 0 the less
4 secondary outcomes
-Compare the improvement of functional capacity measured by the WOMAC.
Time frame: 12 months
-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.
Time frame: 12 months
- 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.
Time frame: 12 months
-Compare the improvement of functional capacity measured by the Oxford Hip score .
Time frame: 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cooled radiofrequency and Intraaticular steroids and local anesthetic injections in people with Hip Pain Chronic, run by Jorge Orduña-Valls at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Orduña, MD (0034664422436, dr.orduna.dolor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Percentage of subjects with improvement measured by VAS after three months. -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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.