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Trial record 12 of 36 for:    complementary and alternative medicine AND Survey

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

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ClinicalTrials.gov Identifier: NCT02081664
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
University of Tromso

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Health Complaints Attributed to Previous Amalgam Fillings Behavioral: lifestyle intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Feasibility Assessment of an Integrated Medical Care Rehabilitation Program for Patients With Continuing Health Complaints After Amalgam Removal - The IMCR Trial
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
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)
Behavioral: lifestyle intervention



Primary Outcome Measures :
  1. achieved patient enrollment rates (number of patients eligible) [ Time Frame: 8 weeks ]
    number of patients who are willing to participate and are eligible


Secondary Outcome Measures :
  1. MYMOP (scale from 0 to 6) [ Time Frame: difference between baseline and 3 months ]
    MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is.


Other Outcome Measures:
  1. MYMOP (scale from 0 to 6) [ Time Frame: difference between baseline and 6 months ]
    MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081664


Locations
Norway
University of Tromsø
Tromsø, Troms, Norway, 9037
Sponsors and Collaborators
University of Tromso
Investigators
Principal Investigator: Frauke Musial, PhD University of Tromso

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT02081664     History of Changes
Other Study ID Numbers: 2014/34974(NSD)
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by University of Tromso:
Amalgam attributed health complaints
feasibility pilot study
integrated medical care program
lifestyle