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Status unknownNCT04859374Be-Home-PainUpdated Jul 29, 2021

Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach

An interventional study of Mindfullness and treatment as usual (TAU) (pharmacological) in Migraine, sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Migraine

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Keywords

  • Chronic Pain;
  • Chronic Migraine;
  • Conditioned Pain Modulation;
  • Mindfulness;
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.

This study's planned enrollment of 35 is below the median of 60 across 2,160 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta is the lead sponsor of 83 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of chronic Migraine and Chronic Neuropathic Pain
  • Written informed consent

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
35 participants (estimated)

Study arms

  • Other
    Treatment as usual (TAU)

    Any pharmacological therapy used for managing chronic pain or chronic migraine

    Drug: treatment as usual (TAU) (pharmacological)

  • Other
    TAU plus behavioral approach

    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

    Behavioral: Mindfullness · Drug: treatment as usual (TAU) (pharmacological)

Interventions

  • BehavioralMindfullness

    Behavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions

  • Drugtreatment as usual (TAU) (pharmacological)

    Any pharmacological therapy used for managing chronic pain or chronic migraine

06

What researchers measure

Primary outcomes

  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.

    Time frame: From the first visit to the first follow up at 3 months till the last follow up at 12 months

Secondary outcomes

  1. Change of pain frequency

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

    Time frame: 6 and 12 months

  2. Change of medication intake

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

    Time frame: 6 and 12 months

  3. Neurophysiological indexes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 and 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04859374
Lead sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Responsible party
Sponsor
First posted
Apr 26, 2021
Start date
Sep 2021 (estimated)
Primary completion
May 2022 (estimated)
Completion
May 2022 (estimated)
Last update
Jul 29, 2021

Study contacts

Licia Grazzi, MD
Contact
licia.grazzi@istituto-besta.it
+39022394 ext. 2366
Renato Mantegazza, MD
Contact
crc@istituto-besta.it
+39022394 ext. 2321

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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