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

NCT04859374 | Unknown

• 1 other identifier: Be-Home-Pain
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Keywords

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

Outcome Measures

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.

  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

  6 and 12 months

• Change of medication intake

  6 and 12 months

• Neurophysiological indexes

  3, 6 and 12 months

• Psychological measures - coping strategies

  6 and 12 months

• Psychological measures - Quality of life

  6 and 12 months

Study Arms (2)

Treatment as usual (TAU)

OTHER

Any pharmacological therapy used for managing chronic pain or chronic migraine

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

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

Interventions

Mindfullness BEHAVIORAL

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

TAU plus behavioral approach

treatment as usual (TAU) (pharmacological) DRUG

Any pharmacological therapy used for managing chronic pain or chronic migraine

TAU plus behavioral approach; Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Co-existent severe medical or psychiatric illnesses
• Practice of mindfulness in the last 12 months

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

MeSH Terms

Conditions

Migraine Disorders; Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Licia Grazzi, MD

CONTACT

+39022394; licia.grazzi@istituto-besta.it

Renato Mantegazza, MD

CONTACT

+39022394; crc@istituto-besta.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: None (Open Label)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 26, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share