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

24. oktober 2017 oppdatert av: 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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Annen: 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.
Andre navn:
  • physical therapist education
  • guidelines implementation
Eksperimentell: 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.
Annen: 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.
Andre navn:
  • physical therapist education
  • guidelines implementation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain intensity (Pain NRS)
Tidsramme: 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)
Tidsramme: 5 weeks after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
5 weeks after randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain intensity (Pain NRS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain attitudes and beliefs for physiotherapists (PABS.PT)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidade Cidade de Sao Paulo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2015

Primær fullføring (Forventet)

1. juli 2016

Studiet fullført (Forventet)

1. juli 2016

Datoer for studieregistrering

Først innsendt

7. april 2015

Først innsendt som oppfylte QC-kriteriene

10. april 2015

Først lagt ut (Anslag)

15. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UNICID032015

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