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Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

2017年10月24日 更新者：Rodrigo Rossi Nogueira Rizzo、Universidade Cidade de Sao Paulo

Efficacy of Educating Physical Therapists on Clinical Practice Guidelines and Pain Management in the Treatment of Patients With Nonspecific Chronic Low Back Pain: a Cluster Randomized Controlled Trial

The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.

調査の概要

状態

引きこもった

条件

介入・治療

詳細な説明

The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each.

The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated.

Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation.

Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

研究の種類

介入

段階

  • 適用できない

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:

  • patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.
  • physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.

Exclusion Criteria:

  • patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.
  • physiotherapists who want to stop the activities for some reason that prevents participation in the study

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：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Untrained Physical Therapists
The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists.
他の：Control
The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.
他の名前：
  • physical therapist education
  • guidelines implementation
実験的：Trained Physical Therapists
The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management.
他の：Trained
The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.
他の名前：
  • physical therapist education
  • guidelines implementation

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
Pain intensity (Pain NRS)
時間枠：5 weeks after randomization
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
5 weeks after randomization
Disability (24-item Roland Morris Disability Questionnaire)
時間枠：5 weeks after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
5 weeks after randomization

二次結果の測定

結果測定
メジャーの説明
時間枠
Pain intensity (Pain NRS)
時間枠：3 and 6 months after randomization
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
3 and 6 months after randomization
Disability ( 24-item Roland Morris Disability Questionnaire)
時間枠：3 and 6 months after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
3 and 6 months after randomization
Fear Avoidance Beliefs (FABQ)
時間枠：5 weeks, 3 months and 6 months after randomization
Fear avoidance belief will be measured by the 16-item Fear Avoidance Belief Questionnaire (FABQ)
5 weeks, 3 months and 6 months after randomization
Pain Catastrophizing (PCS)
時間枠：5 weeks, 3 months and 6 months after randomization
Pain Catastrophizing will be measured by the 13-item Pain Catastrophizing Scale (PCS)
5 weeks, 3 months and 6 months after randomization

その他の成果指標

結果測定
メジャーの説明
時間枠
Pain attitudes and beliefs for physiotherapists (PABS.PT)
時間枠：Baseline and 5 weeks after randomization
Pain Attitudes and Beliefs will be measured by the 19-item Pain Attitudes and Beliefs Scale for Physiotherapists (PABS.PT)
Baseline and 5 weeks after randomization
Adherence to guidelines for physiotherapists (0-100% Low Back Pain Vignettes)
時間枠：Baseline and 5 weeks after randomization
Adherence to guidelines for physiotherapist will be measured by the 0-100% Low Back Pain Vignettes
Baseline and 5 weeks after randomization

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。

スポンサー

Universidade Cidade de Sao Paulo

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

2015年5月1日

一次修了 (予想される)

2016年7月1日

研究の完了 (予想される)

2016年7月1日

試験登録日

最初に提出

2015年4月7日

QC基準を満たした最初の提出物

2015年4月10日

最初の投稿 (見積もり)

2015年4月15日

学習記録の更新

投稿された最後の更新 (実際)

2017年10月26日

QC基準を満たした最後の更新が送信されました

2017年10月24日

最終確認日

2017年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • UNICID032015

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

背中の痛みの臨床試験

Controlの臨床試験

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スポンサーと協力者

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条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

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