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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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)
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 groups in NCT04859374
Study groupRoleWhat they receive
Treatment as usual (TAU)OtherAny pharmacological therapy used for managing chronic pain or chronic migraine
Receives: Drug: treatment as usual (TAU) (pharmacological)
TAU plus behavioral approachOtherAny 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.

  1. 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)
  1. Change of pain frequency

    Decrease in pain frequency, (days of pain per month) assessed by Daily Diary Card.

    Measured: 6 and 12 months

  2. Change of medication intake

    Decrease of number of symptomatic medications per month assessed by Daily Diary Card.

    Measured: 6 and 12 months

  3. Neurophysiological indexes

    Changes in neurophysiological indexes evaluated by quantitative sensory test for conditioned pain modulation analysis.

    Measured: 3, 6 and 12 months

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted26 Apr 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

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)
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

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.

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