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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04859374
Acronym
Be-Home-Pain
Enrollment
35
Registered
2021-04-26
Start date
2021-09-30
Completion date
2022-05-31
Last updated
2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Chronic Pain;, Chronic Migraine;, Conditioned Pain Modulation;, Mindfulness;

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.

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

Sponsors

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

None (Open Label)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of pain intensityFrom the first visit to the first follow up at 3 months till the last follow up at 12 monthsMean 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

MeasureTime frameDescription
Change of medication intake6 and 12 monthsDecrease of number of symptomatic medications per month assessed by Daily Diary Card.
Neurophysiological indexes3, 6 and 12 monthsChanges in neurophysiological indexes evaluated by quantitative sensory test for conditioned pain modulation analysis.
Psychological measures - coping strategies6 and 12 months* Pain Catastrophizing Scale-Italian, PCS-I (Monticone et al., 2012) * cut-off: 0 - 30 normal ranges \> 30 abnormal
Change of pain frequency6 and 12 monthsDecrease in pain frequency, (days of pain per month) assessed by Daily Diary Card.
Psychological measures - Mood6 and 12 months* 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 tests6 and 12 months* 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
Psychological measures - Quality of life6 and 12 months* General Self-Efficacy Scale, GSE ( (Schwarzer et al., 1995) * cut off: 0 - 10 abnormal 10 - 40 normal ranges

Contacts

Primary ContactLicia Grazzi, MD
licia.grazzi@istituto-besta.it+39022394
Backup ContactRenato Mantegazza, MD
crc@istituto-besta.it+39022394

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026