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Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach (Be-Home-Pain)

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

35

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Treatment as usual (TAU)
Any pharmacological therapy used for managing chronic pain or chronic migraine
Any pharmacological therapy used for managing chronic pain or chronic migraine
Sonstiges: 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
Any pharmacological therapy used for managing chronic pain or chronic migraine
Behavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of pain intensity
Zeitfenster: 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.
From the first visit to the first follow up at 3 months till the last follow up at 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of pain frequency
Zeitfenster: 6 and 12 months
Decrease in pain frequency, (days of pain per month) assessed by Daily Diary Card.
6 and 12 months
Change of medication intake
Zeitfenster: 6 and 12 months
Decrease of number of symptomatic medications per month assessed by Daily Diary Card.
6 and 12 months
Neurophysiological indexes
Zeitfenster: 3, 6 and 12 months
Changes in neurophysiological indexes evaluated by quantitative sensory test for conditioned pain modulation analysis.
3, 6 and 12 months
Psychological measures - coping strategies
Zeitfenster: 6 and 12 months
  • Pain Catastrophizing Scale-Italian, PCS-I (Monticone et al., 2012)
  • cut-off: 0 - 30 normal ranges > 30 abnormal
6 and 12 months
Psychological measures - Quality of life
Zeitfenster: 6 and 12 months
  • General Self-Efficacy Scale, GSE ( (Schwarzer et al., 1995)
  • cut off: 0 - 10 abnormal 10 - 40 normal ranges
6 and 12 months
Psychological measures - Mood
Zeitfenster: 6 and 12 months
  • Hospital Anxiety and Depression Scale, HADS (Costantini et al., 1999)
  • cut-off: total score 0 -7 = normal total score > 7 = impairment
6 and 12 months
Psychological measures - Mindfulness specific tests
Zeitfenster: 6 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
6 and 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. September 2021

Primärer Abschluss (Voraussichtlich)

1. Mai 2022

Studienabschluss (Voraussichtlich)

1. Mai 2022

Studienanmeldedaten

Zuerst eingereicht

31. März 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. April 2021

Zuerst gepostet (Tatsächlich)

26. April 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juli 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juli 2021

Zuletzt verifiziert

1. April 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Be-Home-Pain

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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