MigraineBe-Home-PainNCT04859374
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
A study testing Mindfullness and treatment as usual (TAU) (pharmacological) in people with Migraine, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Mindfullness and treatment as usual (TAU) (pharmacological)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic Migraine and Chronic Neuropathic Pain
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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)
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Mindfullness, treatment as usual (TAU) (pharmacological)
- Keywords
- Chronic Pain;, Chronic Migraine;, Conditioned Pain Modulation;, Mindfulness;
- Medical subject headings
- Migraine Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfullnessBehavioural
Behavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions
treatment as usual (TAU) (pharmacological)Drug
Any pharmacological therapy used for managing chronic pain or chronic migraine
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | Other | Any pharmacological therapy used for managing chronic pain or chronic migraine Receives: Drug: treatment as usual (TAU) (pharmacological) |
| TAU plus behavioral approach | Other | 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 Receives: Behavioral: Mindfullness; Drug: treatment as usual (TAU) (pharmacological) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first visit to the first follow up at 3 months till the last follow up at 12 months
Secondary outcomes (7)
Change of pain frequency
Decrease in pain frequency, (days of pain per month) assessed by Daily Diary Card.
Measured: 6 and 12 months
Change of medication intake
Decrease of number of symptomatic medications per month assessed by Daily Diary Card.
Measured: 6 and 12 months
Neurophysiological indexes
Changes in neurophysiological indexes evaluated by quantitative sensory test for conditioned pain modulation analysis.
Measured: 3, 6 and 12 months
Psychological measures - coping strategies
- Pain Catastrophizing Scale-Italian, PCS-I (Monticone et al., 2012)
- cut-off: 0 - 30 normal ranges > 30 abnormal
Measured: 6 and 12 months
Psychological measures - Quality of life
- General Self-Efficacy Scale, GSE ( (Schwarzer et al., 1995)
- cut off: 0 - 10 abnormal 10 - 40 normal ranges
Measured: 6 and 12 months
Psychological measures - Mood
- Hospital Anxiety and Depression Scale, HADS (Costantini et al., 1999)
- cut-off: total score 0 -7 = normal total score > 7 = impairment
Measured: 6 and 12 months
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
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study startSep 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859374
- Sponsor's protocol ID
- Be-Home-Pain
- Acronym
- Be-Home-Pain
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04859374
- Acronym / sponsor ID
- Be-Home-Pain / Be-Home-Pain
- Conditions
- Migraine
- Keywords
- Chronic Pain;, Chronic Migraine;, Conditioned Pain Modulation;, Mindfulness;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | Other | Drug: treatment as usual (TAU) (pharmacological)Any pharmacological therapy used for managing chronic pain or chronic migraine |
| TAU plus behavioral approach | Other | Behavioral: Mindfullness, Drug: treatment as usual (TAU) (pharmacological)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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic Migraine and Chronic Neuropathic Pain
- Written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfullnessBehavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions | Behavioural | TAU plus behavioral approach |
| treatment as usual (TAU) (pharmacological)Any pharmacological therapy used for managing chronic pain or chronic migraine | Drug | TAU plus behavioral approach, Treatment as usual (TAU) |
Primary outcome
Change of pain intensity
Time frame: From the first visit to the first follow up at 3 months till the last follow up at 12 months
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.
7 secondary outcomes
Change of pain frequency
Time frame: 6 and 12 months
Change of medication intake
Time frame: 6 and 12 months
Neurophysiological indexes
Time frame: 3, 6 and 12 months
Psychological measures - coping strategies
Time frame: 6 and 12 months
Psychological measures - Quality of life
Time frame: 6 and 12 months
Psychological measures - Mood
Time frame: 6 and 12 months
Psychological measures - Mindfulness specific tests
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfullness and treatment as usual (TAU) (pharmacological) in people with Migraine, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Licia Grazzi, MD (+39022394 ext. 2366, licia.grazzi@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain intensity (time frame: From the first visit to the first follow up at 3 months till the last follow up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.