Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04859374
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-03-31
Brief Title:
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
Sponsor:
Fondazione IRCCS Istituto Neurologico Carlo Besta
Organization:
Fondazione IRCCS Istituto Neurologico Carlo Besta
Study Overview
Official Title:
Effectiveness of Home- Behavioral Approach by Mindfulness Added to Pharmacological Treatment on Endogenous Pain Modulation in Patients With Chronic Pain Results at Long-term Be-Home-Pain
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Be-Home-Pain
Brief Summary:
Chronic pain is a disabling condition associated with progressive changes and decline in psychological wellbeing According with a modern conceptualization pain has to be considered a biopsychosocial disorder where biological affective social and psychological aspects are strictly connected Although this new conceptualization the implementation of an integral systems approach of psychological tenets into treatments for chronic pain are limited Concerning treatments of chronic pain condition the literature of the last years has demonstrated how clinical benefit can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness Systemic quantitative-somatosensory testing of Conditioned Pain Modulation CPM can be considered a measure of endogenous modulation of pain and it has been used in different clinical experiences to evaluate the effectiveness of different pain treatments even if non pharmacological approaches
Detailed Description:
Chronic pain is a disabling condition associated with progressive changes and decline in psychological wellbeing The burden of this condition is significant and also the epidemiological impact According with a modern conceptualization pain has to be considered a biopsychosocial disorder where biological affective social and psychological aspects are strictly connected Although this new conceptualization the implementation of an integral systems approach of psychological tenets into treatments for chronic pain are limited Concerning treatment of chronic pain condition the literature of the last years has demonstrated how clinical benefit can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness that help patients to become more conscious about their symptoms and able to manage pain without medication
Systemic quantitative-somatosensory testing of Conditioned Pain Modulation CPM can be considered a measure of endogenous modulation of pain and it has been used in different clinical experiences to evaluate the effectiveness of different pain treatments even if non pharmacological approaches Aim of this study A group of patients suffering from Chronic Migraine and Chronic Neuropathic Pain will be studied and followed with a specific mindfulness protocol added to traditional pharmacological therapy performed on-line for 8 weeks In order to determine if the behavioral approach can improve their clinical condition patients will be followed for 12 months after treatments with regular visits every 3 months
Also in order to assess the integrity and improvement of the endogenous pain inhibitory control a conditioned pain modulation paradigm will be performed at baseline and at 3 6 12 months Patients will perform a baseline evaluation of thermal pain and mechanical pain tresholds using the quantitative sensory methods including the determination of heat-generated temporal summation Then at baseline and at 3 6 12 months follow up the CPM paradigm will be performed using two heat painful stimuli a tonic heat stimulus as conditioning stimulus and a phasic heat stimulus as test stimuli
Patients will be treated by traditional pharmacological therapies added to behavioral approach mindfulness on line by using a specific platform STARLEAF TAUMIND Eight weekly one-hour video-sessions of mindfulness practice will be scheduled for patients instructions to manage pain and to encourage the use of strategies for pain management will be given
Moreover instructions for behavioral approach and mindfulness to practice every day will be given daily standardized mindfulness sessions of 12 minutes by smartphone recorded by the expert who generally manages their sessions at the hospital will be scheduled for patients Neuropsychological assessment will be provided at baseline and at every follow up Clinical neurophysiological and neuropsychological results will be compared to those obtained from another group of patients treated by traditional pharmacological treatment TAU This preliminary study will be conducted on 35 patients with diagnosis of CM and Chronic Neuropathic Pain performed at our center
Specific questionnaires for cognitive assessment and disability catastrophizing attitude anxiety depression acceptance pain coping will be performed at baseline and repeated at every follow up PCS GSE HADS CPAQ AAQ MAAS The pain diary will be checked too with scheduled NSR evaluation The questionnaires will be repeated at every follow up and the pain diary will be evaluated
Results will be collected at baseline up to 12 months after treatment for both groups
Systemic quantitative-somatosensory testing of Conditioned Pain Modulation CPM can be considered a measure of endogenous modulation of pain and it has been used in different clinical experiences to evaluate the effectiveness of different pain treatments even if non pharmacological approaches Aim of this study A group of patients suffering from Chronic Migraine and Chronic Neuropathic Pain will be studied and followed with a specific mindfulness protocol added to traditional pharmacological therapy performed on-line for 8 weeks In order to determine if the behavioral approach can improve their clinical condition patients will be followed for 12 months after treatments with regular visits every 3 months
Also in order to assess the integrity and improvement of the endogenous pain inhibitory control a conditioned pain modulation paradigm will be performed at baseline and at 3 6 12 months Patients will perform a baseline evaluation of thermal pain and mechanical pain tresholds using the quantitative sensory methods including the determination of heat-generated temporal summation Then at baseline and at 3 6 12 months follow up the CPM paradigm will be performed using two heat painful stimuli a tonic heat stimulus as conditioning stimulus and a phasic heat stimulus as test stimuli
Patients will be treated by traditional pharmacological therapies added to behavioral approach mindfulness on line by using a specific platform STARLEAF TAUMIND Eight weekly one-hour video-sessions of mindfulness practice will be scheduled for patients instructions to manage pain and to encourage the use of strategies for pain management will be given
Moreover instructions for behavioral approach and mindfulness to practice every day will be given daily standardized mindfulness sessions of 12 minutes by smartphone recorded by the expert who generally manages their sessions at the hospital will be scheduled for patients Neuropsychological assessment will be provided at baseline and at every follow up Clinical neurophysiological and neuropsychological results will be compared to those obtained from another group of patients treated by traditional pharmacological treatment TAU This preliminary study will be conducted on 35 patients with diagnosis of CM and Chronic Neuropathic Pain performed at our center
Specific questionnaires for cognitive assessment and disability catastrophizing attitude anxiety depression acceptance pain coping will be performed at baseline and repeated at every follow up PCS GSE HADS CPAQ AAQ MAAS The pain diary will be checked too with scheduled NSR evaluation The questionnaires will be repeated at every follow up and the pain diary will be evaluated
Results will be collected at baseline up to 12 months after treatment for both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None