Pelvic Pain SyndromeNCT04046406
Pelvic Pain Treated With MR-guided Cryoanalgesia
A study testing MR neurography-guided cryoanalgesia in people with Pelvic Pain Syndrome and Groin Pain, run by Johns Hopkins University at 1 site in United States.
Trial summary
Pelvic pain syndromes have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery. While medical management is the initial therapeutic step, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pelvic Pain Syndrome, Groin Pain, Meralgia Paresthetica
- What is being tested?
- MR neurography-guided cryoanalgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 1 Jan 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 100 years
- Chronic pelvic pain for at least 3 months and no adequate pain relief defined as persistent worst pain 4 or above on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite conservative treatments, including but not limited to oral pain medication including NSAIDs and narcotics, physical therapy, and nerve block.
- The 'worst pain' must be reported to be 4 or above on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine)
- Pain must be from a single lumbosacral nerves confirmed with selective nerve blocks providing adequate temporary pain. The selectivity of the nerve block will be confirmed on MR images documenting that the injected local anesthetic immerses the targeted nerve and that there is absence of spread of local anesthetic to adjacent nerves to exclude confounding anesthesia. Adequate pain relief will be defined by pain relief of greater 50% after the nerve block and rest and with aggravating exercise.
- The target nerve is amenable to cryoablation with MRI guidance
- Cryoablation should be performed within 3 months of the nerve block
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- Known coagulopathy or bleeding disorders are controlled
Who cannot join
- Confounding pain syndromes or conditions.
- Previous nerve surgery
- Currently pregnant, nursing, or wishing to become pregnant during the study
- Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit
- Concurrent participation in other studies that could affect the primary endpoint
Trial locations and contacts
1 site in 1 country.
About this study
Pelvic pain syndromes have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery. While medical management is the initial therapeutic step, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Cryoablation can induce long-lasting nerve conduction blocks with resultant pain relief for several months. The objective of this study is to evaluate the effectiveness of magnetic resonance (MR) neurography-guided cryoanalgesia for the treatment of pelvic and associated pain syndromes.
Read the detailed description
Pelvic pain syndromes including meralgia paresthetica, inguinodynia, and deep gluteal syndrome and others, which are caused by nerves including the the lateral femoral cutaneous nerve (LFCN), genitofemoral nerve (GFN), ilioinguinal nerve (IIN), iliohypogastric nerve (IHN), pudendal nerve (PN), obturator nerve (ON), posterior femoral cutaneous nerve (PFCN), and others, have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery, including episiotomy, orthopedic instrumentation and surgical hernia repair. While medical management is the initial therapeutic step, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Cryoablation of sensory nerves at temperatures of approximately 40 degrees Celsius and below (Cryoanalgesia) can induce long-lasting nerve conduction blocks with resultant pain relief for several months, which could be an effective treatment option for a large number of patients in this group before, instead of, and after failed surgical treatment. Cryoablation affords several advantages over other thermal or chemical ablation techniques, including direct visualization of the ablation zone, decreased intraprocedural and postprocedural pain, and the ability to simultaneously use multiple probes in variable configurations to create tailored additive overlapping ablation zones. In contrast to surgical or heat-mediated ablation, cryoablation does not disrupt the acellular epineurium or perineurium, which reduces the risk of neuroma formation and may allow eventual nerve regeneration, after which the cryoanalgesia can be repeated. Interventional MR neurography at 3 Tesla describes the combined use of high-resolution MRI for the visualization of smallest nerves that are located deep inside the pelvis, targeting, placement of needles and probes, and process monitoring, such as growth of the ice ball and relationship to the target nerves. The use of interventional MR neurography is thus ideally suited to perform cryoanalgesia with the highest technical accuracy and safety. The objective of this study is to evaluate the effectiveness of MR neurography-guided cryoanalgesia for the treatment of pelvic and associated pain syndromes.
- Conditions
- Pelvic Pain Syndrome, Groin Pain, Meralgia Paresthetica, Low Back Pain, Perineal Neuralgia
- Being tested
- MR neurography-guided cryoanalgesia
- Medical subject headings
- Femoral Neuropathy, Low Back Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR neurography-guided cryoanalgesiaDevice
Treatment will be performed using a FDA-approved Galil Medical cryoablation system and FDA-approved Galil Medical cryoablation needles.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic pain syndromes | Experimental | Patients with pelvic pain syndromes who will undergo MR neurography-guided cryoanalgesia Receives: Device: MR neurography-guided cryoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported average pain score
Therapeutic success is defined as 50 percent or more pain reduction and/or an absolute pain level below 2 on an 11-point visual analog pain scale of 0 (no pain) to 10 (pain as bad as subject can imagine).
Measured: Baseline and 12 weeks post cryoablation procedure
Secondary outcomes (5)
Change in pain intensity as assessed by the Brief Pain Inventory (BPI)
This test will assess pain intensity (worst pain, least pain, average pain, pain right now) measured on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine).
Measured: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in percentage pain relief
This test will assess percentage pain relief since baseline on an 11-point visual analogue scale with 10 percent increments with higher scores indicating more relief.
Measured: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in analgesic medication use
This test will assess analgesic medication use in order to assess change in analgesic medications by recording the daily dose and type of medication. Morphine Equivalent Daily Dosing and Comparable NSAID Dose Levels will be used to compare the dose of different pain medications.
Measured: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in pain interference as assessed by the BPI
This test will assess pain interference using a 7-item questionnaire on the BPI (that includes general activity, mood, walking ability, normal walk, relations with other people, sleep, and enjoyment of life) scored on an 11-point visual analogue scale from 0 to 10 with 0 meaning no interference and 10 meaning complete interference.
Measured: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in Self-Assessment of Treatment as assessed by a 5-item questionnaire
The change in the self-assessment of the treatment offered patients will be assessed with a 5-item questionnaire that is graded on a 5-point Likert scale which ranges from -2 to +2 with positive scores indicating better satisfaction with treatment.
Measured: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start13 Nov 2019
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: There were issues with equipment and team fell apart due to departure of some members from the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc.
- Responsible party
- Sponsor
- Investigators
- Jan Fritz, M.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046406
- Sponsor's protocol ID
- IRB00222178
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Pain Treated With MR-guided Cryoanalgesia
- ClinicalTrials.gov ID
- NCT04046406
- Acronym / sponsor ID
- IRB00222178
- Conditions
- Pelvic Pain Syndrome, Groin Pain, Meralgia Paresthetica, Low Back Pain, Perineal Neuralgia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There were issues with equipment and team fell apart due to departure of some members from the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- BTG International Inc.
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 6 Aug 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.
Pelvic pain syndromes have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery. While medical management is the initial therapeutic step, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Cryoablation can induce long-lasting nerve conduction blocks with resultant pain relief for several months. The objective of this study is to evaluate the effectiveness of magnetic resonance (MR) neurography-guided cryoanalgesia for the treatment of pelvic and associated pain syndromes.
Detailed description
Pelvic pain syndromes including meralgia paresthetica, inguinodynia, and deep gluteal syndrome and others, which are caused by nerves including the the lateral femoral cutaneous nerve (LFCN), genitofemoral nerve (GFN), ilioinguinal nerve (IIN), iliohypogastric nerve (IHN), pudendal nerve (PN), obturator nerve (ON), posterior femoral cutaneous nerve (PFCN), and others, have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery, including episiotomy, orthopedic instrumentation and surgical hernia repair. While medical management is the initial therapeutic step, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Cryoablation of sensory nerves at temperatures of approximately 40 degrees Celsius and below (Cryoanalgesia) can induce long-lasting nerve conduction blocks with resultant pain relief for several months, which could be an effective treatment option for a large number of patients in this group before, instead of, and after failed surgical treatment. Cryoablation affords several advantages over other thermal or chemical ablation techniques, including direct visualization of the ablation zone, decreased intraprocedural and postprocedural pain, and the ability to simultaneously use multiple probes in variable configurations to create tailored additive overlapping ablation zones. In contrast to surgical or heat-mediated ablation, cryoablation does not disrupt the acellular epineurium or perineurium, which reduces the risk of neuroma formation and may allow eventual nerve regeneration, after which the cryoanalgesia can be repeated. Interventional MR neurography at 3 Tesla describes the combined use of high-resolution MRI for the visualization of smallest nerves that are located deep inside the pelvis, targeting, placement of needles and probes, and process monitoring, such as growth of the ice ball and relationship to the target nerves. The use of interventional MR neurography is thus ideally suited to perform cryoanalgesia with the highest technical accuracy and safety. The objective of this study is to evaluate the effectiveness of MR neurography-guided cryoanalgesia for the treatment of pelvic and associated pain syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic pain syndromes | Experimental | Device: MR neurography-guided cryoanalgesiaPatients with pelvic pain syndromes who will undergo MR neurography-guided cryoanalgesia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 to 100 years
- Chronic pelvic pain for at least 3 months and no adequate pain relief defined as persistent worst pain 4 or above on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite conservative treatments, including but not limited to oral pain medication including NSAIDs and narcotics, physical therapy, and nerve block.
- The 'worst pain' must be reported to be 4 or above on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine)
- Pain must be from a single lumbosacral nerves confirmed with selective nerve blocks providing adequate temporary pain. The selectivity of the nerve block will be confirmed on MR images documenting that the injected local anesthetic immerses the targeted nerve and that there is absence of spread of local anesthetic to adjacent nerves to exclude confounding anesthesia. Adequate pain relief will be defined by pain relief of greater 50% after the nerve block and rest and with aggravating exercise.
- The target nerve is amenable to cryoablation with MRI guidance
Key exclusion criteria (5 listed)
- Confounding pain syndromes or conditions.
- Previous nerve surgery
- Currently pregnant, nursing, or wishing to become pregnant during the study
- Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit
- Concurrent participation in other studies that could affect the primary endpoint
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 |
|---|---|---|
| MR neurography-guided cryoanalgesiaTreatment will be performed using a FDA-approved Galil Medical cryoablation system and FDA-approved Galil Medical cryoablation needles. | Device | Pelvic pain syndromes |
Primary outcome
Change in self-reported average pain score
Time frame: Baseline and 12 weeks post cryoablation procedure
Therapeutic success is defined as 50 percent or more pain reduction and/or an absolute pain level below 2 on an 11-point visual analog pain scale of 0 (no pain) to 10 (pain as bad as subject can imagine).
5 secondary outcomes
Change in pain intensity as assessed by the Brief Pain Inventory (BPI)
Time frame: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in percentage pain relief
Time frame: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in analgesic medication use
Time frame: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in pain interference as assessed by the BPI
Time frame: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in Self-Assessment of Treatment as assessed by a 5-item questionnaire
Time frame: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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.
Jan Fritz, M.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR neurography-guided cryoanalgesia in people with Pelvic Pain Syndrome and Groin Pain, run by Johns Hopkins University 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 8 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Apr 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in self-reported average pain score (time frame: Baseline and 12 weeks post cryoablation procedure). 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 18 Apr 2023.