Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach (Be-Home-Pain)
Primary Purpose
Migraine
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfullness
treatment as usual (TAU) (pharmacological)
Sponsored by
About this trial
This is an interventional other trial for Migraine focused on measuring Chronic Pain;, Chronic Migraine;, Conditioned Pain Modulation;, Mindfulness;
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic Migraine and Chronic Neuropathic Pain
- Written informed consent
Exclusion Criteria:
- Co-existent severe medical or psychiatric illnesses
- Use of opioids during the 3 months before the inclusion into the protocol
- Practice of mindfulness in the last 12 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Treatment as usual (TAU)
TAU plus behavioral approach
Arm Description
Any pharmacological therapy used for managing chronic pain or chronic migraine
Any pharmacological therapy used for managing chronic pain or chronic migraine added with behavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions
Outcomes
Primary Outcome Measures
Change of pain intensity
Mean NRS (Numerical Rating Scale evaluation from the Daily diary card ) difference of at least 2 points on the scale(the scale range is from 0=no pain to 10 =maximum pain perceived) between MIND/TAU and TAU groups assessed by the daily diary card.
Secondary Outcome Measures
Change of pain frequency
Decrease in pain frequency, (days of pain per month) assessed by Daily Diary Card.
Change of medication intake
Decrease of number of symptomatic medications per month assessed by Daily Diary Card.
Neurophysiological indexes
Changes in neurophysiological indexes evaluated by quantitative sensory test for conditioned pain modulation analysis.
Psychological measures - coping strategies
Pain Catastrophizing Scale-Italian, PCS-I (Monticone et al., 2012)
cut-off: 0 - 30 normal ranges > 30 abnormal
Psychological measures - Quality of life
General Self-Efficacy Scale, GSE ( (Schwarzer et al., 1995)
cut off: 0 - 10 abnormal 10 - 40 normal ranges
Psychological measures - Mood
Hospital Anxiety and Depression Scale, HADS (Costantini et al., 1999)
cut-off: total score 0 -7 = normal total score > 7 = impairment
Psychological measures - Mindfulness specific tests
Mindful Awareness Attention Scale, MAAS (Veneziani et al., 2015) for mindfulness attitude for patients randomized in the MIND/TAU group
cut-off: 15 - 90 normal ranges
Full Information
NCT ID
NCT04859374
First Posted
March 31, 2021
Last Updated
July 28, 2021
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
1. Study Identification
Unique Protocol Identification Number
NCT04859374
Brief Title
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
Acronym
Be-Home-Pain
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)) (TAU/MIND) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Chronic Pain;, Chronic Migraine;, Conditioned Pain Modulation;, Mindfulness;
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual (TAU)
Arm Type
Other
Arm Description
Any pharmacological therapy used for managing chronic pain or chronic migraine
Arm Title
TAU plus behavioral approach
Arm Type
Other
Arm Description
Any pharmacological therapy used for managing chronic pain or chronic migraine added with behavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions
Intervention Type
Behavioral
Intervention Name(s)
Mindfullness
Intervention Description
Behavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions
Intervention Type
Drug
Intervention Name(s)
treatment as usual (TAU) (pharmacological)
Intervention Description
Any pharmacological therapy used for managing chronic pain or chronic migraine
Primary Outcome Measure Information:
Title
Change of pain intensity
Description
Mean NRS (Numerical Rating Scale evaluation from the Daily diary card ) difference of at least 2 points on the scale(the scale range is from 0=no pain to 10 =maximum pain perceived) between MIND/TAU and TAU groups assessed by the daily diary card.
Time Frame
From the first visit to the first follow up at 3 months till the last follow up at 12 months
Secondary Outcome Measure Information:
Title
Change of pain frequency
Description
Decrease in pain frequency, (days of pain per month) assessed by Daily Diary Card.
Time Frame
6 and 12 months
Title
Change of medication intake
Description
Decrease of number of symptomatic medications per month assessed by Daily Diary Card.
Time Frame
6 and 12 months
Title
Neurophysiological indexes
Description
Changes in neurophysiological indexes evaluated by quantitative sensory test for conditioned pain modulation analysis.
Time Frame
3, 6 and 12 months
Title
Psychological measures - coping strategies
Description
Pain Catastrophizing Scale-Italian, PCS-I (Monticone et al., 2012)
cut-off: 0 - 30 normal ranges > 30 abnormal
Time Frame
6 and 12 months
Title
Psychological measures - Quality of life
Description
General Self-Efficacy Scale, GSE ( (Schwarzer et al., 1995)
cut off: 0 - 10 abnormal 10 - 40 normal ranges
Time Frame
6 and 12 months
Title
Psychological measures - Mood
Description
Hospital Anxiety and Depression Scale, HADS (Costantini et al., 1999)
cut-off: total score 0 -7 = normal total score > 7 = impairment
Time Frame
6 and 12 months
Title
Psychological measures - Mindfulness specific tests
Description
Mindful Awareness Attention Scale, MAAS (Veneziani et al., 2015) for mindfulness attitude for patients randomized in the MIND/TAU group
cut-off: 15 - 90 normal ranges
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic Migraine and Chronic Neuropathic Pain
Written informed consent
Exclusion Criteria:
Co-existent severe medical or psychiatric illnesses
Use of opioids during the 3 months before the inclusion into the protocol
Practice of mindfulness in the last 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Licia Grazzi, MD
Phone
+39022394
Ext
2366
Email
licia.grazzi@istituto-besta.it
First Name & Middle Initial & Last Name or Official Title & Degree
Renato Mantegazza, MD
Phone
+39022394
Ext
2321
Email
crc@istituto-besta.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
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