Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Feasibility of an Integrated Medical Care Program for Patients With Continuing Health Complaints After Amalgam Removal (IMCR)

9. juni 2015 opdateret af: University of Tromso

Development and Feasibility Assessment of an Integrated Medical Care Rehabilitation Program for Patients With Continuing Health Complaints After Amalgam Removal - The IMCR Trial

Some patients report relief of symptoms after amalgam removal. However, a large group of patients are still suffering from partly severe health complaints even after the removal of amalgam. To date, no biological/medical explanation for these Amalgam attributed health complaints is available.

The objective of this study is to develop an integrated medical care rehabilitation program and determine if it is a valid and feasible treatment for patients with persistent symptoms after amalgam removal. Such a comprehensive concept has to date not been operationalized in Norway, but information about the feasibility and the challenges around such a rehabilitation program are required, in order to prepare for a possible controlled and randomized study evaluating the effects of the suggested integrative care treatment program. This treatment program will focus on "learning by practicing", hence the study participants will be enrolled into a group program focusing on life-style changes. In addition to the life-style oriented group program, an individualized treatment strategy with therapies out of the spectrum of Complementary and Alternative Medicine (CAM) will be part of the treatment program. This part of the program is based on the results of a survey, related to use of CAM therapies, conducted in 2012 among the members of the patient organization "Forbundet Tenner og Helse".

Participants of this treatment program must amongst other inclusion criteria have removed all dental amalgam fillings and experience symptoms which have not disappeared after removal of the dental fillings. Specific exclusion criteria are stated. The group program consists of 12 sessions which are held once per week for a whole day. Added to this is a choice of CAM therapies from a hierarchic list, established from the survey, and which accordingly is based on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks (end of treatment), and three month later. The aim of this study is to test the feasibility of an integrated medical care rehabilitation program for patients in Norway who have had their Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It combines a lifestyle oriented group program with individualized CAM therapies in form of an outpatient program.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Troms
      • Tromsø, Troms, Norge, 9037
        • University of Tromsø

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

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • The research population should be permanent residents in Norway and be between 20 to 70 years of age and able to comply with the protocol
  • Participants must have removed all dental amalgam fillings (screening by study dentist)
  • Still having health complaints which have not disappeared after removal of the dental amalgam fillings
  • Minimum duration of health complaints of 12 months since removal of the last amalgam filling
  • There is not yet any biological/medical explanation for their health complaints
  • Willing and motivated to take part in the IMCR program as it is described

Exclusion Criteria:

  • Patients with ongoing cancers, severe cardiopulmonal, neurological, or psychiatric diseases or mental retardation (screening by study GP)
  • Life threatening disease
  • Dental conditions requiring treatment before entering the program.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Lifestyle intervention
life-style oriented group program together with an individualized treatment program using therapies out of the spectrum of Complementary and Alternative Medicine (CAM)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
achieved patient enrollment rates (number of patients eligible)
Tidsramme: 8 weeks
number of patients who are willing to participate and are eligible
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MYMOP (scale from 0 to 6)
Tidsramme: difference between baseline and 3 months
MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is.
difference between baseline and 3 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MYMOP (scale from 0 to 6)
Tidsramme: difference between baseline and 6 months
MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is.
difference between baseline and 6 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Frauke Musial, PhD, University of Tromso

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. januar 2014

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

5. marts 2014

Først indsendt, der opfyldte QC-kriterier

6. marts 2014

Først opslået (Skøn)

7. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med livsstilsintervention

3
Abonner