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

2017년 10월 24일 업데이트: 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.

연구 개요

상태

빼는

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
다른: 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.
다른 이름들:
  • physical therapist education
  • guidelines implementation
실험적: 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.
다른: 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.
다른 이름들:
  • physical therapist education
  • guidelines implementation

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain intensity (Pain NRS)
기간: 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)
기간: 5 weeks after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
5 weeks after randomization

2차 결과 측정

결과 측정
측정값 설명
기간
Pain intensity (Pain NRS)
기간: 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)
기간: 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)
기간: 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)
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Pain attitudes and beliefs for physiotherapists (PABS.PT)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Universidade Cidade de Sao Paulo

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 5월 1일

기본 완료 (예상)

2016년 7월 1일

연구 완료 (예상)

2016년 7월 1일

연구 등록 날짜

최초 제출

2015년 4월 7일

QC 기준을 충족하는 최초 제출

2015년 4월 10일

처음 게시됨 (추정)

2015년 4월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 10월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 10월 24일

마지막으로 확인됨

2017년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • UNICID032015

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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희귀 질병

약물 개입

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스폰서 / 협력자

위치

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