Low Back Pain Clinical Trial
Official title:
Pelvic Pain Treated With MR-guided Cryoanalgesia
Verified date | January 2023 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | BTG International Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Baseline and 12 weeks post cryoablation procedure | |
Secondary | 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). | Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure | |
Secondary | 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. | Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure | |
Secondary | 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. | Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure | |
Secondary | 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. | Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure | |
Secondary | 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. | Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure |
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