Osteoarthritis, HipNCT04329884
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With Hip OA Compared to Intra-articular Steroid Injections
A study testing Cooled RFA treatment with COOLIEF* device and intra-articular corticosteroid injection in people with Osteoarthritis, Hip, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This will be a multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Cooled RFA treatment with COOLIEF* device and intra-articular corticosteroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 Jan 2022
- Phase
- Interventional
- 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
- Male or female subjects older than 18 years of age presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days (Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4)
- Relief of patients' typical hip pain symptoms after a positive diagnostic nerve block test and eligibility for cooled radiofrequency ablation of these same nerves
Who cannot join
- Patients who have received any steroid injection in hip within the last 90 days
- Individuals who cannot consent for themselves such as children and subjects with impaired decision making
- Local infection at injection site or active systemic infection
- Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and CRFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
- Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist
- Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
- Allergy or severe renal impairment precluding iodinated contrast or magnevist injection despite standard premedication protocol
- Negative diagnostic nerve block tests
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02511
Antonia F Chen, MD/ MBA, 617-525-5935, afchen@bwh.harvard.edu
Antonia F Chen, MD/ MBA
About this study
Official title: Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
This will be a multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid injections
Read the detailed description
This prospective, single-blinded randomized clinical trial investigates the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function compared with standard of care intra-articular steroid injections. This study also aims to determine if CRFA is more effective at decreasing hip pain from OA after treatment and improving hip function in terms of range of motion and walking mobility when compared to corticosteroid hip injections. The primary outcome of interest is a decrease in visual analog scale (VAS) pain as reported following treatment with either a hip injection or following RFA treatment for patients who are not candidates for total hip arthroplasty (THA). Secondary objectives include physical performance at each follow-up time point including range of motion and 50 ft walk test, Hip disability and Osteoarthritis Outcome Score (HOOS) and PROMIS questionnaires at each follow-up time point, patient satisfaction at 24 weeks after treatment, and the number of subjects requesting additional treatment for hip pain during the follow-up period.
The assessments will be conducted by comparing patients with pain from hip OA who get CRFA treatment versus patients who get a hip corticosteroid injection. The research hypothesis is that CRFA will lead to a greater reduction in pain up to 24 weeks +/- 2 weeks following treatment compared to a hip corticosteroid injection. This may result in patients having greater relief of their hip pain which may improve joint function and quality of life with the availability of a new alternative to treat hip OA.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Cooled RFA treatment with COOLIEF* device, intra-articular corticosteroid injection
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled RFA treatment with COOLIEF* deviceProcedure or surgery
Also called cooled radiofrequency ablation (CRFA)
Patients who are randomized to receive CRFA will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.
intra-articular corticosteroid injectionDrug
Also called steroid injection
Patients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular corticosteroid injections | Active comparator | The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. Radiology guidance will be used to guide needle placement within the affected hip to administer lidocaine and a corticosteroid intra-articularly. Receives: Drug: intra-articular corticosteroid injection |
| Cooled radiofrequency ablation | Active comparator | The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. The HALYARD* COOLIEF* SINERGY* Cooled Radiofrequency Probe (sterile, single use) is inserted through a COOLIEF* SINERGY* Introducer used with fluoroscopy guidance in the AP view to visualize the hip joint and sensory nerve areas over the acetabulum (femoral) and ischium (obturator) where the cooled radiofrequency ablation will be applied to create a focal thermal lesion to encompass and denervate the targeted nerves. Receives: Procedure: Cooled RFA treatment with COOLIEF* device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analog scale (VAS) pain by 1.5 points
VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain.
Secondary outcomes (7)
visual analog scale (VAS) pain scores at each follow-up time point
VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Physical performance (hip range of motion)
Measured: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment
Physical performance (50 ft walk test)
Measured: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment
Hip disability and Osteoarthritis Outcome Score (HOOS)
This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
Measured: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population.
Measured: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Patient satisfaction with the study treatment via Likert scale questionnaire
At the final study visit (week 24+/- 2 weeks), subjects will be asked about their satisfaction with the study treatment via a Likert scale questionnaire. Satisfaction will be measured by the following scale: Very dissatisfied (1), Somewhat dissatisfied (2), Neutral satisfaction (3), Somewhat satisfied (4), and Very satisfied (5). The minimum value will be 1 and the maxim value will be 5. Higher scores are a better outcome, while lower scores are a worse outcome.
Measured: 24 weeks +/- 2 weeks after study treatment
Number of subjects requesting additional treatment for hip pain during the follow-up period
Measured: 12 weeks after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rothman Institute Orthopaedics
- Responsible party
- Principal investigator, Antonia Faustina Chen, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329884
- Sponsor's protocol ID
- Brigham
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, and Outcomes. J Knee Surg. 2019 Jan;32(1):65-71. doi: 10.1055/s-0038-1675418. Epub 2018 Nov 5.
PubMed 30396206Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
PubMed 29095245Davis T, Loudermilk E, DePalma M, Hunter C, Lindley DA, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019 Feb 16:rapm-2018-100051. doi: 10.1136/rapm-2018-100051. Online ahead of print.
PubMed 30772821Bellini M, Barbieri M. Cooled radiofrequency system relieves chronic knee osteoarthritis pain: the first case-series. Anaesthesiol Intensive Ther. 2015;47(1):30-3. doi: 10.5603/AIT.2015.0003.
PubMed 25751290Gupta G, Radhakrishna M, Etheridge P, Besemann M, Finlayson RJ. Radiofrequency denervation of the hip joint for pain management: case report and literature review. US Army Med Dep J. 2014 Apr-Jun:41-51.
PubMed 24706242Rivera F, Mariconda C, Annaratone G. Percutaneous radiofrequency denervation in patients with contraindications for total hip arthroplasty. Orthopedics. 2012 Mar 7;35(3):e302-5. doi: 10.3928/01477447-20120222-19.
PubMed 22385437Kapural L, Jolly S, Mantoan J, Badhey H, Ptacek T. Cooled Radiofrequency Neurotomy of the Articular Sensory Branches of the Obturator and Femoral Nerves - Combined Approach Using Fluoroscopy and Ultrasound Guidance: Technical Report, and Observational Study on Safety and Efficacy. Pain Physician. 2018 May;21(3):279-284.
PubMed 29871372
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
- ClinicalTrials.gov ID
- NCT04329884
- Acronym / sponsor ID
- Brigham
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Rothman Institute Orthopaedics
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 1 Apr 2020 (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 multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid injections
Detailed description
This prospective, single-blinded randomized clinical trial investigates the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function compared with standard of care intra-articular steroid injections. This study also aims to determine if CRFA is more effective at decreasing hip pain from OA after treatment and improving hip function in terms of range of motion and walking mobility when compared to corticosteroid hip injections. The primary outcome of interest is a decrease in visual analog scale (VAS) pain as reported following treatment with either a hip injection or following RFA treatment for patients who are not candidates for total hip arthroplasty (THA). Secondary objectives include physical performance at each follow-up time point including range of motion and 50 ft walk test, Hip disability and Osteoarthritis Outcome Score (HOOS) and PROMIS questionnaires at each follow-up time point, patient satisfaction at 24 weeks after treatment, and the number of subjects requesting additional treatment for hip pain during the follow-up period.
The assessments will be conducted by comparing patients with pain from hip OA who get CRFA treatment versus patients who get a hip corticosteroid injection. The research hypothesis is that CRFA will lead to a greater reduction in pain up to 24 weeks +/- 2 weeks following treatment compared to a hip corticosteroid injection. This may result in patients having greater relief of their hip pain which may improve joint function and quality of life with the availability of a new alternative to treat hip OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular corticosteroid injections | Active comparator | Drug: intra-articular corticosteroid injectionThe hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. Radiology guidance will be used to guide needle placement within the affected hip to administer lidocaine and a corticosteroid intra-articularly. |
| Cooled radiofrequency ablation | Active comparator | Procedure: Cooled RFA treatment with COOLIEF* deviceThe hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. The HALYARD* COOLIEF* SINERGY* Cooled Radiofrequency Probe (sterile, single use) is inserted through a COOLIEF* SINERGY* Introducer used with fluoroscopy guidance in the AP view to visualize the hip joint and sensory nerve areas over the acetabulum (femoral) and ischium (obturator) where the cooled radiofrequency ablation will be applied to create a focal thermal lesion to encompass and denervate the targeted nerves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects older than 18 years of age presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days (Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4)
- Relief of patients' typical hip pain symptoms after a positive diagnostic nerve block test and eligibility for cooled radiofrequency ablation of these same nerves
Key exclusion criteria (8 listed)
- Patients who have received any steroid injection in hip within the last 90 days
- Individuals who cannot consent for themselves such as children and subjects with impaired decision making
- Local infection at injection site or active systemic infection
- Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and CRFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
- Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist
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 RFA treatment with COOLIEF* deviceAlso: cooled radiofrequency ablation (CRFA)Patients who are randomized to receive CRFA will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function. | Procedure or surgery | Cooled radiofrequency ablation |
| intra-articular corticosteroid injectionAlso: steroid injectionPatients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function. | Drug | Intra-articular corticosteroid injections |
Primary outcome
Change in visual analog scale (VAS) pain by 1.5 points
Time frame: up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain.
VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
7 secondary outcomes
visual analog scale (VAS) pain scores at each follow-up time point
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Physical performance (hip range of motion)
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment
Physical performance (50 ft walk test)
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Patient satisfaction with the study treatment via Likert scale questionnaire
Time frame: 24 weeks +/- 2 weeks after study treatment
Number of subjects requesting additional treatment for hip pain during the follow-up period
Time frame: 12 weeks after study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Results publication: PubMed 30396206Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, and Outcomes. J Knee Surg. 2019 Jan;32(1):65-71. doi: 10.1055/s-0038-1675418. Epub 2018 Nov 5.
- Results publication: PubMed 29095245Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
- Results publication: PubMed 30772821Davis T, Loudermilk E, DePalma M, Hunter C, Lindley DA, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019 Feb 16:rapm-2018-100051. doi: 10.1136/rapm-2018-100051. Online ahead of print.
- Results publication: PubMed 25751290Bellini M, Barbieri M. Cooled radiofrequency system relieves chronic knee osteoarthritis pain: the first case-series. Anaesthesiol Intensive Ther. 2015;47(1):30-3. doi: 10.5603/AIT.2015.0003.
- Results publication: PubMed 24706242Gupta G, Radhakrishna M, Etheridge P, Besemann M, Finlayson RJ. Radiofrequency denervation of the hip joint for pain management: case report and literature review. US Army Med Dep J. 2014 Apr-Jun:41-51.
- Results publication: PubMed 22385437Rivera F, Mariconda C, Annaratone G. Percutaneous radiofrequency denervation in patients with contraindications for total hip arthroplasty. Orthopedics. 2012 Mar 7;35(3):e302-5. doi: 10.3928/01477447-20120222-19.
- Results publication: PubMed 29871372Kapural L, Jolly S, Mantoan J, Badhey H, Ptacek T. Cooled Radiofrequency Neurotomy of the Articular Sensory Branches of the Obturator and Femoral Nerves - Combined Approach Using Fluoroscopy and Ultrasound Guidance: Technical Report, and Observational Study on Safety and Efficacy. Pain Physician. 2018 May;21(3):279-284.
- 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 study testing Cooled RFA treatment with COOLIEF* device and intra-articular corticosteroid injection in people with Osteoarthritis, Hip, run by Brigham and Women's Hospital at 1 site in United States.
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 2 inclusion and 8 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 1 Apr 2020. 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 United States. 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.
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 Antonia F Chen, MD/ MBA (617-535-5935, afchen@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analog scale (VAS) pain by 1.5 points (time frame: up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04329884, which also lists 7 linked publications.
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 1 Apr 2020.