Amputation Clinical Trial
Official title:
Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain
NCT number | NCT03255395 |
Other study ID # | 180-16 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 24, 2017 |
Est. completion date | April 2019 |
AIM: To provide initial information on the efficacy (pain reduction) and safety of focused
ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic
pain.
PARTICIPANTS: The study will include 10 amputees (men/women age >18 years old) with chronic
(>3 months) phantom/residual limb pain (NPS ≥ 4).
DESIGN: Patients potentially qualifying for the study will be offered an Informed Consent to
sign prior to further evaluation. Those who accept will sign the informed consent, complete
study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically,
a complete medical history will be obtained to determine the patient's general health status,
current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain
scores will be established. If not performed within six months prior to the evaluation, a
contrast MRI of the stump will be performed. Patients not meeting the study criteria will be
exited from the study as screen failures and not be included in analyses. All qualifying
patients will complete a baseline MRI exam on treatment day. Any patient not meeting study
criteria at Imaging will be exited as screen failures.
After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment.
These patients will then be followed for 6-months post-ExAblate treatment; the patients will
complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months
after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after
treatment to assess their pain status, their quality of life and safety. Data regarding
dosage and frequency of analgesic intake for the management of post amputation NP will be
collected. Relevant cost data will be collected in order to enable an assessment of the total
cost of the procedure.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Men and women amputees, aged 18 and older 2. Patients who are able and willing to give consent and able to attend all study visits 3. Patients who are suffering from post-amputation phantom/residual limb pain for at least 3 months 4. Patient with average pain intensity on a 0-10 numerical pain scale (NPS) = 4 during a 3 days period prior to enrollment irrespective of medication use 5. Patient whose targeted (treated) lesion is deeper than 10-mm from the skin 6. Targeted (treated) neuroma is clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible Exclusion Criteria: 1. Patients with any acute or unstable medical condition (e.g., infection, cardiac condition, uncontrolled diabetes mellitus, uncontrolled hypertension) that is expected to hinder them from completing this study 2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >250 pounds (113kg), etc. 3. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 4. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.) 5. Are participating or have participated in another clinical trial in the last 30 days 6. Patients with persistent undistinguishable pain (pain source unidentifiable) 7. Patients whose neuroma is < 10-mm from the skin, blood vessels or bone 8. Patients with more than three neuromas in the affected limb 9. Targeted (treated) neuroma is NOT visible by non-contrast MRI 10. Targeted neuroma is not accessible to ExAblate due to scar tissue or any other reason |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the average daily pain | Change from baseline in the average daily pain intensity, measured for 3 consecutive days, on the Numerical Pain Scale (NPS), an 11-point numeric rating scale. | Up to 6 months |
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