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Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain (CPS)

5. november 2013 oppdatert av: Florian Wepner, Orthopedic Hospital Vienna Speising

The Long-term Effect of an Outpatient Intervention Program With a Behavioral Therapy Approach in Patients With Chronic Back or Neck Pain With a Focus on Psychosocial Aspects

To investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

BACKGROUND: Sustained success of ambulant intervention programs consisting of individual and group physiotherapy in patients with with chronic unspecific back or neck pain (cBP) has not been conclusively proven. It's still not clear whether one can achieve such success by devoting greater attention to psychosocial factors.

OBJECTIVE: We investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on cBP. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

DESIGN: Prospective, randomized controlled trial

SETTINGS, INTERVENTION: 64 patients were assigned to intervention group (IG) and 57 to control group (CG). All were examined, informed about cBP, and were encouraged to stay active and perform exercises according to specific instructions provided in a neck- or back-book. The IG received 9 units of physiotherapy and 2 units of occupational therapy, conducted with a behavioral therapy approach. Efficacy of treatment was evaluated after 6 and 58 weeks.

MEASUREMENTS: Pain (VAS), quantity of painkillers consumed, sick leave days, Oswestry-Disability-Index (ODI), SF-36, FABQ.

Studietype

Intervensjonell

Registrering (Faktiske)

121

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Østerrike
      • Vienna, Østerrike, 1130
        • Orthopedic Hospital Vienna Speising

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 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • minimum age 18 years, maximum age: men 55 years, women 50 years.
  • the patients had been on sick leave for a minimum of 4 and a maximum of 22 days during the preceding 12 months because of nonspecific spinal symptoms in the back or neck.
  • The patients had to be working at the start of the study.

Exclusion Criteria:

  • Specific causes of spinal symptoms (after spinal surgery, known vertebral body fractures, disk prolapse with motor deficits or other radicular lesions, tumor, osteomyelitis, spondylodiscitis, rheumatic disease, osteoporosis).
  • Retired persons, those in the process of being screened for retirement, unemployed persons,
  • pregnancy or persons on maternity leave
  • Planned surgery during the phase of intervention
  • persons who were unable to participate in the intervention program for other reasons (physical, psychological, linguistic or organizational).

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Training group
Physiotherapy and occupational therapy: Training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour.
Atferdsmessig: Physiotherapy and occupational therapy
Members of the training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour. Every patient of the IG was trained to perform a neck or back intervention program specifically suited to his/her needs. The training was conducted in a single session by one of three experienced physiotherapists (with mean work experience of 6 years). After this training the patients completed eight group training units consisting a maximum number of 8 participants, each unit with a duration of one hour, over a maximum period of six weeks.
Ingen inngripen: Control Group
Members of the control group were referred to their general practitioner or specialist for further care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain
Tidsramme: After 0 / 6 / 58 Weeks
To evaluate the main hypothesis, current pain and mean pain during the preceding week and the preceding 3 months were determined on a visual analog scale (VAS; 0-100, lower scores indicate less severe pain)
After 0 / 6 / 58 Weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Social function, psychological wellbeing and emotional role function
Tidsramme: After 0 / 6 / 58 weeks
To evaluate social function, psychological wellbeing and emotional role function we used the 36-item short form health survey (SF-36; scales 0-100, lower scores indicate poorer social, psychological and emotional quality of life)
After 0 / 6 / 58 weeks
Functional impairment
Tidsramme: After 0 / 6 / 58 weeks
The Oswestry disability index was used to measure functional impairment.
After 0 / 6 / 58 weeks
Anxiety, insecurity in social contacts and compulsiveness
Tidsramme: After 0 / 6 / 58 weeks
Anxiety, insecurity in social contacts and compulsiveness were registered on the brief symptoms inventory (BSI), which is an abridged version of SCL-90_R. The BSI addresses subjective experience of impairment based on a list of symptoms that are partly physical and partly psychological. The time frame is seven days.
After 0 / 6 / 58 weeks
Sick leave days
Tidsramme: After 0 / 58 weeks
The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired.
After 0 / 58 weeks
Painkillers
Tidsramme: After 0 / 58 weeks
The number of painkillers taken per day were inquired.
After 0 / 58 weeks
Fear avoidance behavior
Tidsramme: After 0 / 6 / 58 weeks
Fear avoidance behavior was determined by means of the fear avoidance beliefs questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs)
After 0 / 6 / 58 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Orthopedic Hospital Vienna Speising

Etterforskere

  • Hovedetterforsker: Florian Wepner, Dr., Orthopedic Hospital Vienna Speising
  • Studiestol: Martin Friedrich, Prof., Orthopedic Hospital Vienna Speising
  • Studieleder: Julia Hahne, Mag., Orthopedic Hospital Vienna Speising

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. mars 2006

Primær fullføring (Faktiske)

1. februar 2008

Studiet fullført (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først innsendt

29. august 2013

Først innsendt som oppfylte QC-kriteriene

5. november 2013

Først lagt ut (Anslag)

13. november 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. november 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2013

Sist bekreftet

1. november 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Praev123

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