- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01447953
Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care
Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Falun, Sverige, 79182
- The County Council of Dalarna; Primary Health Care units
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of days of sickness absence from work
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Return-to-work after sickness absence
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ALAR-2009RS
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Muskuloskeletal nacksmärta
-
The University of Texas Health Science Center,...EurofinsAvslutadOdontogen Deep Space Neck InfectionFörenta staterna
-
University Children's Hospital, ZurichAvslutadEmergency Front of Neck Airway hos barnSchweiz
-
Korea University Anam HospitalKorea UniversityAvslutadSmärtmätning | Visual Analog Pain Scale
-
Alanya Alaaddin Keykubat UniversityAvslutadSterilisering, Tubal | Visual Analog Pain Scale
-
The University of Texas Health Science Center,...IndragenDeep Neck Space InfectionsFörenta staterna
-
Turkish Ministry of Health, Kahramanmaras Provincial...RekryteringVisual Analog Pain ScaleKalkon
-
Cairo UniversityHar inte rekryterat ännuDeep Neck Flexors Training | Post isometrisk avslappning
-
Ankara UniversityAvslutadSmärtmätning | Visual Analog Pain ScaleKalkon
-
East Carolina UniversityIndragen
-
University Hospital, GrenobleAvslutadDövhet | Visual Analog Pain ScaleFrankrike
Kliniska prövningar på Activity targeted pain rehabilitation
-
Linkoeping UniversityOstergotland County Council, Sweden; Fibromyalgia foundationHar inte rekryterat ännuÖvervikt och fetma | Smärta, kronisk | Användning av mobiltelefon | Dålig näring
-
Rigshospitalet, DenmarkFrederiksberg University Hospital; Defactum, Central Denmark RegionAktiv, inte rekryterande
-
Bahçeşehir UniversityNevsehir Haci Bektas Veli UniversityHar inte rekryterat ännuAnkel stukningar | Funktionell prestanda | Kinesiofobi | Sensoriskt underskott | Ankel instabilitetKalkon
-
Kutahya Health Sciences UniversityAvslutadKronisk smärta | Juvenil idiopatisk artritKalkon
-
Universiteit AntwerpenUniversity Hospital, Antwerp; Cliniques universitaires Saint-Luc- Université...Rekrytering
-
Marmara UniversityAvslutadAxial spondyloartrit | Central sensibiliseringKalkon
-
University Hospital, Clermont-FerrandAvslutad