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Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care

14. december 2015 opdateret af: Catharina Gustavsson, RPT PhD, Uppsala University

Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial

The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.

Patients seeking care due to disabling back, neck or shoulder pain at seven primary health care units in the County of Dalarna, Sweden, was randomly allocated to ALAR or usual multimodal rehabilitation. Between and within-group differences on return-to-work, sickness absence and disability will be evaluated at 10 weeks, six months, one and two years post-treatment.

The enrollment of patients was ended on preterm in june 2013. Due to changes in the organization in primary health care it was no longer possible to ensure that treatment arms could be delivered as intended. Data collection up to 1-year follow-up is completed. Data from longterm follow-up at 2 years will be completed in june 2015. Data analyses and reporting of results is presently undertaken. The number of enrolled participants is not enough to reach statistical power. Thus, results will need to be interpreted with caution.

Still the results of this pragmatic study will be of importance for the planning of a full scale study to accurately evaluate the effects of ALAR, to be conducted in primary care.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sverige
      • Falun, Sverige, 79182
        • The County Council of Dalarna; Primary Health Care units

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Persons seeking primary health care due to back, neck or shoulder pain
  • Aged 18 to 60 years
  • Being on sick leave or disability compensation
  • Able to understand, read and write Swedish

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Activity targeted pain rehabilitation
A new activity and life-role targeting pain rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work.
Andet: Activity targeted pain rehabilitation
An activity and life-role targeting rehabilitation programme (ALAR) provided by one of the care givers in the multi-professional rehabilitation teams at each of the eight participating primary health care centres, by ten weekly 1-hour treatment sessions.
Aktiv komparator: Treatment as usual
Usual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden.
Andet: Treatment as usual
Usual treatment with type of treatment modalities, number, frequency and duration of visits according to the judgement of the muli-professional teams at each primary health care centre.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of days of sickness absence from work
Tidsramme: 6 months
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
6 months
Number of days of sickness absence from work
Tidsramme: 1 year
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
1 year
Number of days of sickness absence from work
Tidsramme: 2 years
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Return-to-work after sickness absence
Tidsramme: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Number of participants that return to work after sickness absence, i.e. that were on sick leave before the study and that has returned to work after the study.
Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Disability
Tidsramme: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Pain-related disability according to Pain Disability Index (PDI).
Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Uppsala University

Samarbejdspartnere

Dalarna County Council, Sweden
Center for Clinical Research Dalarna, Sweden
REHSAM, Sweden

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

9. september 2011

Først indsendt, der opfyldte QC-kriterier

5. oktober 2011

Først opslået (Skøn)

6. oktober 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALAR-2009RS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

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Placeringer

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