Hip OsteoarthritisPhase 3NCT04876859
Comparative Study Between Steroid Plus Anesthetic Block and CRF in Participants With Hip Osteoarthritis
A Phase 3 study testing CRF of anterior sensitive branches to the hip and Anesthetic block with steroid injection of anterior sensitive branches to the hip in people with Hip Osteoarthritis and Chronic Pain, run by University of Brasilia at 1 site in Brazil.
Trial summary
This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Chronic Pain
- What is being tested?
- CRF of anterior sensitive branches to the hip and Anesthetic block with steroid injection of anterior sensitive branches to the hip
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jun 2021to 30 Nov 2024
- Phase
- Phase 3
- 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
- Participants 18 years or older
- Symptomatic unilateral hip osteoarthritis (OA)
- Pain for more than 6 months in the groin, anterior, anterolateral ou lateral region
- OA radiologically classified as Kellgren and Lawrence Tipo II-IV,
- VAS ≥ 4
- Considered non-responder to conservative treatment for the participant for 6 months.
- In case of difficulty in selecting participants with symptomatic unilateral OA, symptomatic bilateral hip OA will be admitted and submitted to the same treatment on both sides, after notification and approval from the Ethic Board of each institution involved.
Who cannot join
- Participants with radiculopathy ipsolateral
- Knee OA ipsolateral,
- Previous hip arthroplasty
- Pain exclusively in the posterior region of the hip
- Infiltration of the hip for less than 3 months
- Neurological disease compromising gait
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- Peripheral neuropathy
- Psychiatric disease that compromise collaboration with the protocol
- Implanted pacemaker
- Prothrombin Activity Time (PT/INR) > 3 and
- Litigation process related to the disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Radiofrequency of Anterior Sensory Branches in Chronic Hip Pain Due to Hip Osteoarthritis: A Randomized Clinical Trial
This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis.
Read the detailed description
This prospective, double-blinded (participant and outcome assessor) clinical trial was designed to investigate the results of the intervention Continuous Radiofrequency (CRF) in the treatment of participants with chronic hip pain secondary to hip osteoarthritis. Participants will be randomized in a 2-arm, parallel groups. The intervention group will be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. The sham group will be submitted to the same anesthetic block, followed by a simulation of CRF use. The surgeon performing the procedures will only be informed of the randomization after completing the anesthetic block on the participants to avoid bias at its accuracy. Participants will be evaluated at four follow-up: before intervention and after 1, 12, and 24 weeks, to access the Western Ontario and McMaster Universities score (WOMAC) as the primary outcome.
- Conditions
- Hip Osteoarthritis, Chronic Pain
- Being tested
- CRF of anterior sensitive branches to the hip, Anesthetic block with steroid injection of anterior sensitive branches to the hip
- Medical subject headings
- Osteoarthritis, Hip, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRF of anterior sensitive branches to the hipProcedure or surgery
Steroid and anesthetic extra articular injection followed by denervation using CRF at 90 celsius degree during a period 90 minutes at the sensitive branches of obturator and femoral nerve, separately.
Anesthetic block with steroid injection of anterior sensitive branches to the hipProcedure or surgery
Corticosteroid and anesthetic extra articular injection at the sensitive branches of obturator and femoral nerve, only
| Study group | Role | What they receive |
|---|---|---|
| Conventional Radiofrequency Group | Active comparator | Will be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. Receives: Procedure: CRF of anterior sensitive branches to the hip |
| Anesthetic plus steroid group | Sham comparator | The sham group will be submitted to the same anesthetic block as described in the intervention group, followed by a simulation of CRF use. Receives: Procedure: Anesthetic block with steroid injection of anterior sensitive branches to the hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (WOMAC)
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.
Measured: Baseline to 24 weeks ± 1 week.
Secondary outcomes (8)
Change in Pain Visual Analogue Scale
The pain visual analogue scale (VAS) is a unidimensional measure of pain intensity, in a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme, "no pain" (score 0) and " worst pain ever" (score 100).
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Harris Hip Score (HHS)
The Harris Hip Score (HHS) is a joint-specific measure, and it consists of two sections: questions and a physical examination, including a range of motion and deformity items. The score has a maximum of 100 points with a maximum of 44 points for pain, 47 for function, 4 points for absence of deformity, and 5 points for a range of motion. The highest score of 100 points indicates the best function and no pain.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Pain Medication Intake
To evaluate pain medication we will use a scale ranging from 0 to 4 (0= no medication; 0 = no medication; 1= use of dipyrone or paracetamol; 2= use of NSAIDs; 3= use of opiate derivatives; 4= routinely scheduled opiate derivatives), considering the last 48 hours.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Isometric Peak Force
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Peak Force of hip flexors, abductors, adductors and extensors.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Time to Reach Peak Force
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Time to Reach Peak Force of hip flexors, abductors, adductors and extensors.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Average Force
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Average Force of hip flexors, abductors, adductors and extensors. We will also determine intra and inter-rater reliability for isometric force of hip flexors, abductors, adductors and extensors.
Measured: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Evaluation of intra and inter-rater reliability of Lafayette Manual Muscle Testing System Model-01165 in subjects with hip Osteoarthritis.
To determine intra and inter-rater reliability of the Hand lend dynamometer Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) in accessing peak force, time to reach peak force and average force of hip flexors, abductors, adductors and extensors, the first 20 participants included in this study will be evaluated by the principal investigator and outcome assessor at the baseline.
Measured: Baseline
Change in Global Satisfaction
To evaluate participant satisfaction, we will use 5 points Likert Scale, ranging from 0 to 4 (0= none _ no good at all, ineffective intervention; 1= poor _ some effect but unsatisfactory; 2= fair _ reasonable effect but could be better; 3= good _ satisfactory effect with occasional episodes of pain or stiffness; 4= excellent _ ideal response, virtually pain-free).
Measured: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start8 Jun 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Why it stopped: Main researcher changed institutions, making it unfeasible to be completed by the others participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Luiz Q. Durigan, University of Brasilia
- Investigators
- João Durigan, PhD, Study director, Universidade de Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876859
- Sponsor's protocol ID
- CAAE: 40347320.1.1001.0025
- Status last verified
- May 2023
- First submitted
- 26 Apr 2021
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Radiofrequency of Anterior Sensory Branches in Chronic Hip Pain Due to Hip Osteoarthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04876859
- Acronym / sponsor ID
- CAAE: 40347320.1.1001.0025
- Conditions
- Hip Osteoarthritis, Chronic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Main researcher changed institutions, making it unfeasible to be completed by the others participants.
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 7 May 2021 (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.
This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis.
Detailed description
This prospective, double-blinded (participant and outcome assessor) clinical trial was designed to investigate the results of the intervention Continuous Radiofrequency (CRF) in the treatment of participants with chronic hip pain secondary to hip osteoarthritis. Participants will be randomized in a 2-arm, parallel groups. The intervention group will be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. The sham group will be submitted to the same anesthetic block, followed by a simulation of CRF use. The surgeon performing the procedures will only be informed of the randomization after completing the anesthetic block on the participants to avoid bias at its accuracy. Participants will be evaluated at four follow-up: before intervention and after 1, 12, and 24 weeks, to access the Western Ontario and McMaster Universities score (WOMAC) as the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Radiofrequency Group | Active comparator | Procedure: CRF of anterior sensitive branches to the hipWill be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. |
| Anesthetic plus steroid group | Sham comparator | Procedure: Anesthetic block with steroid injection of anterior sensitive branches to the hipThe sham group will be submitted to the same anesthetic block as described in the intervention group, followed by a simulation of CRF use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants 18 years or older
- Symptomatic unilateral hip osteoarthritis (OA)
- Pain for more than 6 months in the groin, anterior, anterolateral ou lateral region
- OA radiologically classified as Kellgren and Lawrence Tipo II-IV,
- VAS ≥ 4
Key exclusion criteria (11 listed)
- Participants with radiculopathy ipsolateral
- Knee OA ipsolateral,
- Previous hip arthroplasty
- Pain exclusively in the posterior region of the hip
- Infiltration of the hip for less than 3 months
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 |
|---|---|---|
| CRF of anterior sensitive branches to the hipSteroid and anesthetic extra articular injection followed by denervation using CRF at 90 celsius degree during a period 90 minutes at the sensitive branches of obturator and femoral nerve, separately. | Procedure or surgery | Conventional Radiofrequency Group |
| Anesthetic block with steroid injection of anterior sensitive branches to the hipCorticosteroid and anesthetic extra articular injection at the sensitive branches of obturator and femoral nerve, only | Procedure or surgery | Anesthetic plus steroid group |
Primary outcome
Quality of Life (WOMAC)
Time frame: Baseline to 24 weeks ± 1 week.
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.
8 secondary outcomes
Change in Pain Visual Analogue Scale
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Harris Hip Score (HHS)
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Pain Medication Intake
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Isometric Peak Force
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Time to Reach Peak Force
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Average Force
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Evaluation of intra and inter-rater reliability of Lafayette Manual Muscle Testing System Model-01165 in subjects with hip Osteoarthritis.
Time frame: Baseline
Change in Global Satisfaction
Time frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
João Durigan, PhD study director
Universidade de Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CRF of anterior sensitive branches to the hip and Anesthetic block with steroid injection of anterior sensitive branches to the hip in people with Hip Osteoarthritis and Chronic Pain, run by University of Brasilia at 1 site in Brazil.
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 7 inclusion and 11 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: paused, as of the sponsor's last update on 24 May 2023. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (WOMAC) (time frame: Baseline to 24 weeks ± 1 week.). 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 24 May 2023.