Phantom Limb Pain Triggered by Micturition

NCT03855930 | Unknown

• 1 other identifier: 0012-18-LOE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Phantom Limb Pain ( PLP) is pain that is perceived and referred to a region of the body that is no longer present. in most patients, severity and frequency of phantom pain attacks gradually decrease over several weeks to 2 years following amputation, however in 5-10% significant pain remains a serious problem. It has been hypothesized, that deprivation of various inputs from the limbs to the brain cause an abnormal neuro-signature to be produced generating cortical maladaptive neuroplasticity and reorganization. Areas representing the amputated body part are taken over by neighboring representational zones in both the somatosensory and motor cortex generating pain in absence of stimuli. A seminal paper published by Lotze et al "Phantom movements and pain: a functional magnetic resonance imaging (fMRI) study in upper limb amputees. - participants had to pucker their lips at a metronome-paced speed while functional magnetic resonance images were taken. Only in amputees with phantom-limb pain did a shift of the mouth representation into the hand representation occur; those without pain and the healthy control do not display a similar shift. Scarce reports have been made on a similar phenomenon- micturition induced lower limb phantom pain. We speculate that a similar maladaptive central nerve system (CNS) plasticity in which this genital representation would invade cortical areas with somatotopic affiliation to the lower extremity could be implicated in the pathophysiology of this phenomenon.

Conditions

Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• FMRI data analysis

  FMRI data analysis signifying, statistically significant uni-spatial voxel activity during micturition, in the study groups.

  18 months

Study Arms (3)

micturition induced PLP

10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. All patients will go through functional MRI study

Diagnostic Test: functional MRI

non micturition induced PLP

10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.All patients will go through functional MRI study

Diagnostic Test: functional MRI

healthy volunteers

10 healthy volunteers. All patients will go through functional MRI study

Diagnostic Test: functional MRI

Interventions

functional MRI DIAGNOSTIC_TEST

During the study, standard motor and sensory paradigms will be performed to establish anatomical and functional patterns in the non-painful state. The patient will then be asked to urinate (to an external collecting tube system).

healthy volunteers; micturition induced PLP; non micturition induced PLP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. 10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. 2. 10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. 3. 10 healthy volunteers

You may qualify if:

• months or more post amputation, no anatomical stump pathology
• Ambulatory and to comply with study protocol
• Suffering from significant pain (VAS\>??). pain level has plateaued for at lest 2 months prior to enrolment.
• Pain is perceived to be located in the missing limb
• Pain level is brought up or increases (by at least 3 VAS points) by micturition.
• Maneuvers causing abdominal pressure elevation do not generate similar symptoms.
• Subject received an explanation about the nature of the study and agrees to provide written informed consent
• Subject is capable and willing to follow all study-related procedures

You may not qualify if:

• Any condition inhibiting MRI study (e.g.Pacemakers or other implantable neurostimulators, ….)
• Subject has any condition, which precludes compliance with study instructions.
• Subject suffers from life threatening conditions
• Anatomical limitations that would prevent successful FMRI study
• Other medical conditions precluding FMRI study - e.g., claustrophobia
• Women gender- due to problematic usage of external urinating device during fMRI study

Sponsors & Collaborators

• Loewenstein Hospital: lead
• Tel Aviv University: collaborator

Study Sites (2)

Loewenstein Rehabilitation Center

Raanana, 43100, Israel

Location

Loewenstein Rehabilitation Center

Raanana, Israel

Location

Related Publications (3)

• Michels L, Blok BF, Gregorini F, Kurz M, Schurch B, Kessler TM, Kollias S, Mehnert U. Supraspinal Control of Urine Storage and Micturition in Men--An fMRI Study. Cereb Cortex. 2015 Oct;25(10):3369-80. doi: 10.1093/cercor/bhu140. Epub 2014 Jun 26.

  PMID: 24969474 RESULT

• Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.

  PMID: 12849487 RESULT

• Shy M, Fung S, Boone TB, Karmonik C, Fletcher SG, Khavari R. Functional magnetic resonance imaging during urodynamic testing identifies brain structures initiating micturition. J Urol. 2014 Oct;192(4):1149-54. doi: 10.1016/j.juro.2014.04.090. Epub 2014 Apr 21.

  PMID: 24769029 RESULT

MeSH Terms

Conditions

Phantom Limb

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Motti Ratmansky, MD

  Loewenstein Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Motti Ratmansky, MD

CONTACT

+972097709029; mottir@clalit.org.il

Amir Haim, MD

CONTACT

+972549765999; amirhaim@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: February 25, 2019
• Primary Completion: February 2, 2020
• Study Completion: February 2, 2020
• Last Updated: February 27, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)