Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02141568
Status:
TERMINATED
Last Update Posted:
2019-04-05
First Post:
2014-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
Sponsor:
Soroka University Medical Center
Organization:
Study Overview
Official Title:
Effectiveness and Cost-Effectiveness Analysis of Mind-Body Interventions in a Multi-Disciplinary Clinic for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low patient compliance and dropout during the period defined for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to check the medical efficacy and economic benefits of multidisciplinary care in patients with unexplained medical complaints and consume medical services frequently.
Detailed Description:
Background:
Somatic or "medically unexplained" symptoms and syndromes are common and are seen by physicians across almost every medical specialty. In many instances, these phenomena can cause a great deal of pain and frustration, restrict function and reduce patients' quality of life. Despite their frequency and severity, medical personnel often experience a great deal of difficulty in coping with such complaints and patients may be shuttled from specialist to specialist, often with little or no symptomatic relief and at a great deal of expense to the medical system. Many researchers now believe that these seemingly unrelated and "unexplained" conditions in fact share common psycho-physiological mechanisms, such as being catalyzed as a result of trauma or excessive stress, being mediated by the limbic system and affecting inhibitory sensory pathways.
Purpose of the study:
Testing the efficacy and cost-efficiency of a holistic multidisciplinary treatment methodology for medically unexplained symptoms (MUS).
Stages of the Study:
The study wil lbe conducted via two arms:
1. A reterospective study of patients attending the Functional Neurology clinic a Soroka UMC between the years 2014-2018 in which patient records will be obtained via the regional offices of Clalit Health Services and analyzed in order to learn the effects of mind-body therapies on health care utilization.
2. A prospective study of new patients arriving at the "functional neurology" clinic at Soroka UMC. Members of the second arm will be asked if they would be willing to participate in the study by their neurologist. Participants who have agreed to join the study will fill out Self-report measures at the beginning of their treatment, at the end of treatment (3 months) and 6 months after the start of treatment and 12 months after the start of treatment.
Expected Results
1. A decrease in expense rates and use of medical services
2. An increase in patient satisfaction
3. An increase in patient-reported health and quality of life
Somatic or "medically unexplained" symptoms and syndromes are common and are seen by physicians across almost every medical specialty. In many instances, these phenomena can cause a great deal of pain and frustration, restrict function and reduce patients' quality of life. Despite their frequency and severity, medical personnel often experience a great deal of difficulty in coping with such complaints and patients may be shuttled from specialist to specialist, often with little or no symptomatic relief and at a great deal of expense to the medical system. Many researchers now believe that these seemingly unrelated and "unexplained" conditions in fact share common psycho-physiological mechanisms, such as being catalyzed as a result of trauma or excessive stress, being mediated by the limbic system and affecting inhibitory sensory pathways.
Purpose of the study:
Testing the efficacy and cost-efficiency of a holistic multidisciplinary treatment methodology for medically unexplained symptoms (MUS).
Stages of the Study:
The study wil lbe conducted via two arms:
1. A reterospective study of patients attending the Functional Neurology clinic a Soroka UMC between the years 2014-2018 in which patient records will be obtained via the regional offices of Clalit Health Services and analyzed in order to learn the effects of mind-body therapies on health care utilization.
2. A prospective study of new patients arriving at the "functional neurology" clinic at Soroka UMC. Members of the second arm will be asked if they would be willing to participate in the study by their neurologist. Participants who have agreed to join the study will fill out Self-report measures at the beginning of their treatment, at the end of treatment (3 months) and 6 months after the start of treatment and 12 months after the start of treatment.
Expected Results
1. A decrease in expense rates and use of medical services
2. An increase in patient satisfaction
3. An increase in patient-reported health and quality of life
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SCRC12014 | OTHER | Soroka Clinical Research Center (SCRC) | View |