Health Complaints Attributed to Previous Amalgam Fillings Clinical Trial
— IMCROfficial title:
Development and Feasibility Assessment of an Integrated Medical Care Rehabilitation Program for Patients With Continuing Health Complaints After Amalgam Removal - The IMCR Trial
| Verified date | June 2015 |
| Source | University of Tromso |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway: Data Protection Authority |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Norway | University of Tromsø | Tromsø | Troms |
| Lead Sponsor | Collaborator |
|---|---|
| University of Tromso |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | MYMOP (scale from 0 to 6) | MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is. | difference between baseline and 6 months | No |
| Primary | achieved patient enrollment rates (number of patients eligible) | number of patients who are willing to participate and are eligible | 8 weeks | No |
| Secondary | MYMOP (scale from 0 to 6) | MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is. | difference between baseline and 3 months | No |