Neuromodulation Methods for Suppressing Phantom Limb Pain
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Phantom Limb Pain
- Sponsor
- Skolkovo Institute of Science and Technology
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Visual analogue scale (VAS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS - Dorsal Root Ganglion Stimulation), and motor cortex (MCS - Motor Cortex Stimulation). The study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
- •Age between 18 and 65 years.
- •Duration since amputation is at least 6 months.
- •Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
- •Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
- •Signed consent to participate in the study.
Exclusion Criteria
- •Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
- •Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
- •Presence of severe orthopedic deformity in the limb above the level of amputation.
- •History of cancer.
- •History of epilepsy.
- •Complicated traumatic brain injury (TBI) or a history of stroke.
- •Inability to undergo electrostimulation due to other somatic pathology.
- •Purulent-septic pathology.
- •Drug addiction (including a history of).
- •Congenital anomaly of upper limb development.
Outcomes
Primary Outcomes
Visual analogue scale (VAS)
Time Frame: Up to 4 months
The Visual Analog Scale (VAS) is a 10 cm line used to measure pain intensity. One end of the line represents \"no pain,\" while the other end signifies \"worst possible pain.\" The line can be either horizontal or vertical.
SF-36
Time Frame: up to 1 year
The questionnaire consists of 36 items grouped into eight scales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale ranges from 0 to 100, where 100 represents full health. Higher scores indicate better quality of life, with two summary measures: physical and mental well-being.
Secondary Outcomes
- Sensory mapping(up to 4 months)
- Pain detect(Up 1 year)
- DN 4(up to 1 year)
- Hospital Anxiety and Depression Scale, HADS(up to 1 year)
- Sensory threshold(up to 6 months)