Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Many studies have been performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. However the evidence on their effectiveness is still limited and the results of recent studies are conflicting.
The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. The Intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce parafunction and hyperfunction of the craniofacial and cervical muscles during the day.
Comparison(s): Group of employees that will receive a cognitive/physical programme (Intervention), compared to a similar group of employees that will not receive the Intervention (Controls); (frequency of headache and neck and shoulder pain).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study.
Exclusion Criteria:
- Because of the pragmatic design, no exclusion criteria are required for this study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: EN
|
Relaxation exercises once a day, visual feedback, exercises for neck and shoulder
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Analgesic drug consumption after 6 and 12 months
Tidsramme: 12 months
|
12 months
|
|
Headache index after 6 and 12 months
Tidsramme: 12 months
|
12 months
|
|
Neck and shoulder pain index after 6 and 12 months
Tidsramme: 12 months
|
12 months
|
|
Muscle tenderness at palpation after 6 and 12 months
Tidsramme: 12 months
|
12 months
|
|
Psychiatric comorbidity and psychosomatic symptoms prevalence
Tidsramme: 12 months
|
12 months
|
|
Frequency of pain in head/neck area after 12 months in both groups
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Franco Mongini, Professor, University of Turin, Italy
- Ledende efterforsker: Luca Ferrero, DDS, University of Turin, Italy
- Ledende efterforsker: Alessandro Ugolini, DDS, University of Turin, Italy
- Ledende efterforsker: Eugenia Rota, MD, University of Turin, Italy
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5147SD2003.0271
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