Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Implementation of a Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain

15. november 2019 oppdatert av: Mälardalen University

A Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain - Evaluation of the Implementation Process and Outcome

Implementation of a behavioral medicine (BM) approach in physical therapy (PT) for patients with persistent musculoskeletal pain is in accordance with the state of science. Translation of research into clinical PT practice is challenging and may demand active implementation strategies.

The aim is to evaluate the implementation of a behavioural medicine approach for patients with persistent musculoskeletal pain concerning sustainable health benefits and sick-leave, as well as the cost-effectiveness of the implemented treatment.

Treatment outcomes for patients from two groups of physical therapists in primary care will be compared. In one group active implementation strategies have been employed, and in the other (control) passive implementation strategies during a 6-months intervention period. Patients are recruited during one-year after the implementation period.

The short and long-term effects of the implementation of the BM approach in PT treatment on patients' sick-leave, activity and participation, and health related quality of life will be compared to the patients from control condition clinics. The cost-effect and cost-benefit of an implementation of a behavioral medicine approach in physical therapy is evaluated from the perspective of the health care organization and society.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The aim is to investigate the short and long-term effects for the implementation of a behavioral medicine approach in physical therapy on patients' sick-leave, activity and participation, and health related quality of life, compared to the control condition. Further the aim is to evaluate the cost-effect and cost-benefit of an active implementation of a behavioural medicine approach in physical therapy, compared to the passive implementation in the control condition.

In total 109 primary care patients with musculoskeletal pain ≥ 4 weeks are included consecutively in the active implementation and passive implementation (control) clinics. The sample size was based on a priori power analysis on differences in primary outcome between conditions and expected attrition. Patients from both conditions are included during the first year after the implementation period.

Data collection has been at onset and end of patients' treatment period, and will be at 6, 12, and 18 months post treatment (in both implementation and control clinics).

Recommended core outcomes regarding body structure, activity and participation are used. Primary outcomes: Participation in work life defined as days of sick-leave and participation in everyday life. Secondary outcomes will be patients' ratings of global treatment effects and pain intensity. Process measures: prognostic psychosocial factors possible to address in physical therapy such as functional self-efficacy, fear of movement and patient expectations on treatment effects. Depression, seen as a confounder, will be controlled for. Calculation of costs will include avoidable cost of the implementation, sunk costs will be ignored. Direct health care costs, i.e. use of health care services will be identified, measured and priced to assess costs from a societal perspective. Indirect costs, i.e. production loss due to sick leave and health care visits will be estimated. Cost-benefit will be calculated from the perspective of the society. Economic benefits will be measured as the net value of production gained for society, with an appropriate discount rate. Costs for society will be calculated on direct health care costs.

Data analyses: Regression models are used to compare patient outcomes between implementation and control clinics and performed per protocol and on an intention-to-treat-basis. Total costs, i.e. direct health care costs, direct and indirect non-health care costs and incremental costs, will be compared between conditions. A ratio between difference in outcome scores and costs between baseline and 6, 12, and 18 months post treatment will be. Incremental costs will be calculated per cost-benefit ratio associated with treatments in the two conditions. Bootstrapping is used for confidence intervals for cost-effectiveness and cost-benefit ratios.

Studietype

Intervensjonell

Registrering (Faktiske)

109

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
      • Gavle, Sverige
        • Region Gävleborg
      • Nykoping, Sverige, SE-61188
        • Landstinget Sörmland
      • Vasteras, Sverige, SE-72189
        • Region Västmanland

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 who presents for physical therapy in primary care.
  • 18 - 65 years of age
  • musculoskeletal pain for 4 weeks or more
  • ability to speak and understand spoken and written Swedish

Exclusion criteria:

  • systemic disease
  • malignity
  • serious spinal pathology
  • osteoarthritis waiting for surgery
  • diagnosed depression
  • neurological disease or injury that severely affect activity capacity

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Active implementation clinics
Patients recruited by physical therapists who underwent an implementation period with active implementations strategies, such as supervision, web lectures, peer learning in groups consisting of colleagues. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these active implementation strategies.
Atferdsmessig: Active implementation clinics
Physical therapy treatment as the physical therapist chooses
Aktiv komparator: Passive implementation clinics
Patients recruited by physical therapists who underwent an implementation period with passive implementations strategies, such as written material and a short web lecture. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these passive implementation strategies
Atferdsmessig: Passive implementation clinics
Physical therapy treatment as the physical therapist chooses

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in days of sick-leave
Tidsramme: through study completion, an average of 1 year
Self-reports and sick-leave data from the Swedish Social Insurance Administration
through study completion, an average of 1 year
Change in pain-related disability using Pain Disability Index
Tidsramme: through study completion, an average of 1 year
Pain Disability Index: Measure of disruptions in seven dimensions of everyday life. Self-reports on a11-graded numerical rating scale
through study completion, an average of 1 year
Change in health related quality of life using EQ-5D
Tidsramme: through study completion, an average of 1 year
EuroQol, Quality of life scale in 5 dimensions (EQ-5D) which provides a simple descriptive profile and a single index value for health status.
through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale
Tidsramme: through study completion, an average of 1 year
Patients Global Impression of Change (PGIC) scale which provides the patient's belief about the treatment effect rated on a 7-graded scale
through study completion, an average of 1 year
Change in self-efficacy for daily activities using the Self-efficacy Scale
Tidsramme: through study completion, an average of 1 year
The Self-efficacy Scale: ratings of self-efficacy for 20 common activities in daily life
through study completion, an average of 1 year
Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire
Tidsramme: through study completion, an average of 1 year
The Catastrophizing subscale of the Coping Strategies Questionnaire: ratings of pain-related catastrophizing thoughts
through study completion, an average of 1 year
Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia
Tidsramme: through study completion, an average of 1 year
The Tampa Scale of Kinesiophobia: ratings of fear and avoidance of movement
through study completion, an average of 1 year

Samarbeidspartnere og etterforskere

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

Sponsor

Mälardalen University

Etterforskere

  • Hovedetterforsker: Anne Söderlund, professor, Mälardalen University, Box 883, SE-721 23 Västerås, Sweden

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. november 2016

Primær fullføring (Forventet)

1. september 2022

Studiet fullført (Forventet)

1. november 2022

Datoer for studieregistrering

Først innsendt

20. mars 2017

Først innsendt som oppfylte QC-kriteriene

13. april 2017

Først lagt ut (Faktiske)

18. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 140369

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No plan to share individual participant data (IPD) because the participants have been assured of confidentiality and that only the researchers in the Project will have access to IPD

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Muskel- og skjelettsmerter

Kliniske studier på Active implementation clinics

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Uruguay

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere