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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.

調査の概要

状態

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条件

詳細な説明

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.

研究の種類

介入

入学 (予想される)

35

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
他の: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
他の: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change of pain intensity
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change of pain frequency
時間枠: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
時間枠:6 and 12 months
Decrease of number of symptomatic medications per month assessed by Daily Diary Card.
6 and 12 months
Neurophysiological indexes
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2021年9月1日

一次修了 (予想される)

2022年5月1日

研究の完了 (予想される)

2022年5月1日

試験登録日

最初に提出

2021年3月31日

QC基準を満たした最初の提出物

2021年4月22日

最初の投稿 (実際)

2021年4月26日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月29日

QC基準を満たした最後の更新が送信されました

2021年7月28日

最終確認日

2021年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • Be-Home-Pain

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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