Osteoarthritis Nos, of Sacroiliac JointNCT02808962
Optimal Performance of RFA of the Nerves Supplying the Posterior Sacroiliac Joint Complex.
A study testing Cooled RFA of sacral lateral branches in people with Osteoarthritis Nos, of Sacroiliac Joint, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The procedure is supposed to ablate the sacral lateral branches that form the medial cluneal nerves (MCN). The anatomy of the sacral lateral branches is such that, in addition to innervating the SIJ, distal branches of these nerves also innervate the skin over the buttock through MCN (12,13). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Nos, of Sacroiliac Joint
- What is being tested?
- Cooled RFA of sacral lateral branches
- 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
- 17 Feb 2016to 1 Jun 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
- Predominantly axial pain below the L5 vertebrae
- Pain duration of ≥ 6 months
- Three day average NRS scores of ≥ 3/10
- Age greater than 18 years
- Failure of conservative treatment including nonsteroidal anti-inflammatory medications and physical therapy
- Pain localized in the SIJ region
- Failure of injection of steroids into the SIJ or sacroiliac ligaments to achieve adequate improvement -
Who cannot join
- Radicular pain
- Systemic infection or localized infection at the anticipated introducer entry site
- Pregnancy
- Allergy to Lidocaine
- Individuals unable to consent
- Bleeding dyscrasias
- Non-English speaking patients
- Patients that cannot read or write
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: In Pursuit of the Optimal Performance of Radiofrequency Ablation of the Nerves Supplying the Posterior Sacroiliac Joint Complex.
The procedure is supposed to ablate the sacral lateral branches that form the medial cluneal nerves (MCN). The anatomy of the sacral lateral branches is such that, in addition to innervating the SIJ, distal branches of these nerves also innervate the skin over the buttock through MCN (12,13). SLB blocks (usually with 0.5 ml of 1% Lidocaine or 0.5% Bupivacaine) are performed proximal to the origin of both the nerves to the SIJ and the cutaneous branches. Therefore, a technically accurate block should anesthetize not only the SIJ but also the skin of the buttock regardless of the patient symptoms. Hypoesthesia of the buttock would, therefore, be a quality-assurance sign that the block has been performed in a technically correct fashion. Similarly, if the target nerves have been accurately ablated by RFA hypoesthesia of the buttock should ensue, as an expected effect of the procedure.
Read the detailed description
Typical standard of care for these patients is initial visit followed by two diagnostic blocks ((0.5 ml) of 1 % Lidocaine per level). They are asked to complete the pain diary and if they experience a 75% or more decrease in the NRS, they are scheduled for Cooled RFA of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of L5 nerve.
If patients do not experience adequate pain relief after either of these injections, it is determined that the cooled RFA procedure will not work for them. Therefore, if they fail to receive adequate pain relief after either of these two injections, they will exit the study and other alternatives will be explored. The patient will also exit the study if they fail to achieve success 1 month after RFA treatment. The treatment of the study patients will not deviate from the standard of care.
- All study Patients
- Visit 1 - Initial Visit During the initial visit, the eligible patients will undergo a routine physical examination where it will be determined if the subject is eligible for the study. If eligible, the physician will explain the study and determine if subject is interested. Informed consent will then be obtained and the patient will be scheduled for the first fluoroscopy-guided diagnostic block with 0.5 ml of 1% Lidocaine of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of the L5 nerve. The baseline information, including a 3-day average Numeric Rating Scale (NRS) regarding level of pain, the Oswestry Disability Index (ODI), and analgesic consumption will also be obtained during the initial visit.
- Visit 2 - First Diagnostic Block The participant will be asked questions about their level of pain (NRS) and any change in analgesia medications since their last visit. They will then undergo the first fluoroscopy-guided diagnostic block (DB) with 0.5 ml of 1 % Lidocaine per level. A brief physical examination - including a sensory exam of the buttock area - will be performed after the block and the patients will be given a pain diary to complete after the procedure until the pain intensity reaches pre-procedure intensity (see the flowchart attached). The results of the exam will be documented, i.e ; "no sensory deficit" or "sensory deficit to pinprick in the buttock area". Pain diary will require the patients to scale their pain intensity using the NRS on an hourly basis and to document their activities during this period time. This will be done in accordance with the International Spine Intervention Society practice guidelines with respect to the diagnostic blocks as a prerequisite for radiofrequency ablation. (14). A follow-up appointment will be scheduled in 3-5 days after the first set of diagnostic blocks (this appointment will be pre-scheduled in conjunction with the appointment for the first diagnostic block).
- Visit 3 - First Follow-up (3-5 days after first block) The patient will be evaluated, including NRS and analgesia medications, and the pain diary reviewed. If a 75% or more decrease in the NRS is reported for ≥ 2 hours after the procedure, the patient will be scheduled for a second set of fluoroscopy-guided diagnostic blocks (see Module 1). According to the International Spine Intervention Society and most of the major insurers' guidelines, two "positive"diagnostic blocks are necessary in order to proceed to RFA. If the first diagnostic block doesn't provide temporary ≥ 75% pain relief, the patient will exit the study.
- Visit 4 - Confirmatory Block The participant will be asked questions about their level of pain (NRS) and any change in analgesia medications since their last visit. They will then undergo the second fluoroscopy-guided diagnostic block with 0.5 ml of 1 % Lidocaine per A brief physical examination - including a sensory exam of the buttock area - will be performed after the block and the patients will be given a pain diary to complete after the procedure until the pain intensity reaches the baseline (see the attached flowchart). The results of the sensory exam will be documented, i.e ; "no sensory deficit" or "sensory deficit to pinprick in the buttock area". This will be done in accordance with the International Spine Intervention Society practice guidelines with respect to the diagnostic blocks as a prerequisite for radiofrequency ablation. (14). A follow-up appointment will be scheduled in 3-5 days after the second set of diagnostic blocks (this appointment will be pre-scheduled in conjunction with the appointment for the second diagnostic block).
- Visit 5 - Second Follow-up (3-5 days after 2nd block) The patients will be evaluated again at their second follow-up appointment, including NRS and analgesia medications, and the pain diary reviewed. If this block is "negative," the patient will exit the study after the follow-up and will be treated by alternative methods; if it is "positive", the patient will be scheduled for a Cooled RFA.
- Visit 6 - Cooled RFA These subjects that experienced a "positive" response to two sets of diagnostic blocks will undergo Cooled RFA of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of L5 nerve as described by Kapural et al. (15). All patients will be evaluated for buttock hypoesthesia immediately after the intervention.
- Visit 7 - 1 Month Follow-up after Cooled RFA At this time, the following data will be collected: 3-day average NRS scores, satisfaction with the treatment, ODI, and analgesic consumption. Physical evaluation, including sensory exam of the buttock area will be done. If the procedure is successful (NRS scores improvement by ≥ 50% and satisfaction with the treatment) the patients will be scheduled for the second and final follow-up at 6 months post-intervention. Otherwise, they will exit the study.
- Visit 8 (Final) - 6 Month Follow-up after Cooled RFA At this time, the following data will be collected: 3-day average NRS scores, satisfaction with the treatment, ODI, and analgesic consumption. Physical evaluation, including sensory exam of the buttock area will be done.
- Data to be collected The following data will be collected for each patient: Name, MRN, date of visit, NRS scores, ODI information, concomitant meds, pain diary, treatment satisfaction, and sensory exam info.
- Conditions
- Osteoarthritis Nos, of Sacroiliac Joint
- Being tested
- Cooled RFA of sacral lateral branches
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled RFA of sacral lateral branchesProcedure or surgery
A single target will be identified at the junction of the sacral ala and S1 superior articular process, corresponding to the location of the L5 dorsal ramus. Then, utilizing a stainless steel Epsilon Ruler (Kimberly Clark, Irving, TX, USA), three targets will be localized 8-10 mm lateral to the S1 and S2 posterior sacral foramen at the 2:30, 4:00, and 5:30 positions. Two targets will be localized at the S3 level. Local infiltration with 1% lidocaine and minimal sedation with IV midazolam will be utilized. Once suitable sensory and motor stimulation are verified and impedance is acceptable, each target will be anesthetized with 1 mL of 1% lidocaine prior to each lesion being created at 60 degrees centigrade for 2 minutes and 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Cooled Radiofrequency Ablation | Other | This is a single arm, prospective observational study. All subjects enrolled are patients that meet the inclusion criteria, as deemed by a physician.
Typical standard of care for these patients is an initial visit followed by two diagnostic blocks ((0.5ml) of 1% Lidocaine per level). Subjects are asked to complete the pain diary and if they experience a 75% or more decrease in the NRS, they are scheduled for Cooled RFA of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of L5 nerve. Receives: Procedure: Cooled RFA of sacral lateral branches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence/ presence of post-procedural buttock hypoesthesia
Measured: 6 months postprocedure
Secondary outcomes (4)
Numeric pain rating scale (0-10)
Measured: 6-month postprocedure
Oswestry Disability Index (ODI)
Measured: 6-month postprocedure
Analgesic consumption
Measured: 6-month postprocedure
Patient satisfaction with the treatment?
Binary "Yes" or "No" answer.
Measured: 6-month postprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start17 Feb 2016
- Primary completion4 Feb 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Nos, of Sacroiliac JointStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yakov Vorobeychik, Milton S. Hershey Medical Center
- Investigators
- Yakov Vorobeychik, Principal investigator, Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808962
- Sponsor's protocol ID
- STUDY00002420
- Status last verified
- Jul 2022
- First submitted
- 23 May 2016
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
1.Patel, Gross, Brown, et al. A randomized,placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med 2012;13:383-98. 3.Tubbs, Levin, Loukas, et al. Anatomy and landmarks for the superior and middle cluneal nerves: Application to posterior iliac crest harvest and entrapment syndromes. J Neurosurg Spine 2010;13:356-569. 4 Roberts S, Burnham R, Ravichandiran K, et al. Cadaveric study of sacroiliac joint innervation: implications for diagnostic blocks and radiofrequency ablation. Regional Anesthesia and Pain Madicine 2014; 39:1-9 5. Bogduk N. (ed). Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013 6. Kapural, Stojanovic, Bensitel. et al. Cooled Radiofrequency (RF) of L5 dorsal ramus for RF denervation of the sacroiliac joint: technical report. Pain Med. 2010; 11:53-7
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Pursuit of the Optimal Performance of Radiofrequency Ablation of the Nerves Supplying the Posterior Sacroiliac Joint Complex.
- ClinicalTrials.gov ID
- NCT02808962
- Acronym / sponsor ID
- STUDY00002420
- Conditions
- Osteoarthritis Nos, of Sacroiliac Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
The procedure is supposed to ablate the sacral lateral branches that form the medial cluneal nerves (MCN). The anatomy of the sacral lateral branches is such that, in addition to innervating the SIJ, distal branches of these nerves also innervate the skin over the buttock through MCN (12,13). SLB blocks (usually with 0.5 ml of 1% Lidocaine or 0.5% Bupivacaine) are performed proximal to the origin of both the nerves to the SIJ and the cutaneous branches. Therefore, a technically accurate block should anesthetize not only the SIJ but also the skin of the buttock regardless of the patient symptoms. Hypoesthesia of the buttock would, therefore, be a quality-assurance sign that the block has been performed in a technically correct fashion. Similarly, if the target nerves have been accurately ablated by RFA hypoesthesia of the buttock should ensue, as an expected effect of the procedure.
Detailed description
Typical standard of care for these patients is initial visit followed by two diagnostic blocks ((0.5 ml) of 1 % Lidocaine per level). They are asked to complete the pain diary and if they experience a 75% or more decrease in the NRS, they are scheduled for Cooled RFA of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of L5 nerve.
If patients do not experience adequate pain relief after either of these injections, it is determined that the cooled RFA procedure will not work for them. Therefore, if they fail to receive adequate pain relief after either of these two injections, they will exit the study and other alternatives will be explored. The patient will also exit the study if they fail to achieve success 1 month after RFA treatment. The treatment of the study patients will not deviate from the standard of care.
- All study Patients
- Visit 1 - Initial Visit During the initial visit, the eligible patients will undergo a routine physical examination where it will be determined if the subject is eligible for the study. If eligible, the physician will explain the study and determine if subject is interested. Informed consent will then be obtained and the patient will be scheduled for the first fluoroscopy-guided diagnostic block with 0.5 ml of 1% Lidocaine of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of the L5 nerve. The baseline information, including a 3-day average Numeric Rating Scale (NRS) regarding level of pain, the Oswestry Disability Index (ODI), and analgesic consumption will also be obtained during the initial visit.
- Visit 2 - First Diagnostic Block The participant will be asked questions about their level of pain (NRS) and any change in analgesia medications since their last visit. They will then undergo the first fluoroscopy-guided diagnostic block (DB) with 0.5 ml of 1 % Lidocaine per level. A brief physical examination - including a sensory exam of the buttock area - will be performed after the block and the patients will be given a pain diary to complete after the procedure until the pain intensity reaches pre-procedure intensity (see the flowchart attached). The results of the exam will be documented, i.e ; "no sensory deficit" or "sensory deficit to pinprick in the buttock area". Pain diary will require the patients to scale their pain intensity using the NRS on an hourly basis and to document their activities during this period time. This will be done in accordance with the International Spine Intervention Society practice guidelines with respect to the diagnostic blocks as a prerequisite for radiofrequency ablation. (14). A follow-up appointment will be scheduled in 3-5 days after the first set of diagnostic blocks (this appointment will be pre-scheduled in conjunction with the appointment for the first diagnostic block).
- Visit 3 - First Follow-up (3-5 days after first block) The patient will be evaluated, including NRS and analgesia medications, and the pain diary reviewed. If a 75% or more decrease in the NRS is reported for ≥ 2 hours after the procedure, the patient will be scheduled for a second set of fluoroscopy-guided diagnostic blocks (see Module 1). According to the International Spine Intervention Society and most of the major insurers' guidelines, two "positive"diagnostic blocks are necessary in order to proceed to RFA. If the first diagnostic block doesn't provide temporary ≥ 75% pain relief, the patient will exit the study.
- Visit 4 - Confirmatory Block The participant will be asked questions about their level of pain (NRS) and any change in analgesia medications since their last visit. They will then undergo the second fluoroscopy-guided diagnostic block with 0.5 ml of 1 % Lidocaine per A brief physical examination - including a sensory exam of the buttock area - will be performed after the block and the patients will be given a pain diary to complete after the procedure until the pain intensity reaches the baseline (see the attached flowchart). The results of the sensory exam will be documented, i.e ; "no sensory deficit" or "sensory deficit to pinprick in the buttock area". This will be done in accordance with the International Spine Intervention Society practice guidelines with respect to the diagnostic blocks as a prerequisite for radiofrequency ablation. (14). A follow-up appointment will be scheduled in 3-5 days after the second set of diagnostic blocks (this appointment will be pre-scheduled in conjunction with the appointment for the second diagnostic block).
- Visit 5 - Second Follow-up (3-5 days after 2nd block) The patients will be evaluated again at their second follow-up appointment, including NRS and analgesia medications, and the pain diary reviewed. If this block is "negative," the patient will exit the study after the follow-up and will be treated by alternative methods; if it is "positive", the patient will be scheduled for a Cooled RFA.
- Visit 6 - Cooled RFA These subjects that experienced a "positive" response to two sets of diagnostic blocks will undergo Cooled RFA of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of L5 nerve as described by Kapural et al. (15). All patients will be evaluated for buttock hypoesthesia immediately after the intervention.
- Visit 7 - 1 Month Follow-up after Cooled RFA At this time, the following data will be collected: 3-day average NRS scores, satisfaction with the treatment, ODI, and analgesic consumption. Physical evaluation, including sensory exam of the buttock area will be done. If the procedure is successful (NRS scores improvement by ≥ 50% and satisfaction with the treatment) the patients will be scheduled for the second and final follow-up at 6 months post-intervention. Otherwise, they will exit the study.
- Visit 8 (Final) - 6 Month Follow-up after Cooled RFA At this time, the following data will be collected: 3-day average NRS scores, satisfaction with the treatment, ODI, and analgesic consumption. Physical evaluation, including sensory exam of the buttock area will be done.
- Data to be collected The following data will be collected for each patient: Name, MRN, date of visit, NRS scores, ODI information, concomitant meds, pain diary, treatment satisfaction, and sensory exam info.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooled Radiofrequency Ablation | Other | Procedure: Cooled RFA of sacral lateral branchesThis is a single arm, prospective observational study. All subjects enrolled are patients that meet the inclusion criteria, as deemed by a physician. Typical standard of care for these patients is an initial visit followed by two diagnostic blocks ((0.5ml) of 1% Lidocaine per level). Subjects are asked to complete the pain diary and if they experience a 75% or more decrease in the NRS, they are scheduled for Cooled RFA of the lateral branches of S1, S2, and S3 dorsal rami nerves and of the dorsal ramus of L5 nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Predominantly axial pain below the L5 vertebrae
- Pain duration of ≥ 6 months
- Three day average NRS scores of ≥ 3/10
- Age greater than 18 years
- Failure of conservative treatment including nonsteroidal anti-inflammatory medications and physical therapy
Key exclusion criteria (8 listed)
- Radicular pain
- Systemic infection or localized infection at the anticipated introducer entry site
- Pregnancy
- Allergy to Lidocaine
- Individuals unable to consent
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 of sacral lateral branchesA single target will be identified at the junction of the sacral ala and S1 superior articular process, corresponding to the location of the L5 dorsal ramus. Then, utilizing a stainless steel Epsilon Ruler (Kimberly Clark, Irving, TX, USA), three targets will be localized 8-10 mm lateral to the S1 and S2 posterior sacral foramen at the 2:30, 4:00, and 5:30 positions. Two targets will be localized at the S3 level. Local infiltration with 1% lidocaine and minimal sedation with IV midazolam will be utilized. Once suitable sensory and motor stimulation are verified and impedance is acceptable, each target will be anesthetized with 1 mL of 1% lidocaine prior to each lesion being created at 60 degrees centigrade for 2 minutes and 30 seconds. | Procedure or surgery | Cooled Radiofrequency Ablation |
Primary outcome
Absence/ presence of post-procedural buttock hypoesthesia
Time frame: 6 months postprocedure
4 secondary outcomes
Numeric pain rating scale (0-10)
Time frame: 6-month postprocedure
Oswestry Disability Index (ODI)
Time frame: 6-month postprocedure
Analgesic consumption
Time frame: 6-month postprocedure
Patient satisfaction with the treatment?
Time frame: 6-month postprocedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background1.Patel, Gross, Brown, et al. A randomized,placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med 2012;13:383-98. 3.Tubbs, Levin, Loukas, et al. Anatomy and landmarks for the superior and middle cluneal nerves: Application to posterior iliac crest harvest and entrapment syndromes. J Neurosurg Spine 2010;13:356-569. 4 Roberts S, Burnham R, Ravichandiran K, et al. Cadaveric study of sacroiliac joint innervation: implications for diagnostic blocks and radiofrequency ablation. Regional Anesthesia and Pain Madicine 2014; 39:1-9 5. Bogduk N. (ed). Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013 6. Kapural, Stojanovic, Bensitel. et al. Cooled Radiofrequency (RF) of L5 dorsal ramus for RF denervation of the sacroiliac joint: technical report. Pain Med. 2010; 11:53-7
- 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.
Yakov Vorobeychik principal investigator
Hershey Medical Center
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 of sacral lateral branches in people with Osteoarthritis Nos, of Sacroiliac Joint, run by Milton S. Hershey Medical Center 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 7 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: finished, as of the sponsor's last update on 11 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absence/ presence of post-procedural buttock hypoesthesia (time frame: 6 months postprocedure). 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 NCT02808962, which also lists 1 linked publication.
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 11 Jul 2022.