Clinical trial NCT02141568: Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurasthenia
Chronic Pain
Chronic Headache
Keywords: Cost-effective
Unexplained Medical Symptoms
Frequent Attenders
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Men or women
* Age 18 or higher
* Treated at the Functional Neurology clinic at Soroka UMC

Exclusion Criteria:

* patients with chronic illness such as cancer, dialysis patients, or any other severe identified illness
* patients who do not speak Hebrew
* bedridden patients
* Schizophrenia, dementia and other severe mental illness

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: 6 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 12 months
measure: Anxiety
timeFrame: 6 months
measure: Depression
timeFrame: 6 months
measure: Catastrophization
timeFrame: 6 months
measure: Locus of Control
timeFrame: 6 months
measure: Existence of Symptoms
timeFrame: 6 months
measure: Pain Symptoms and Functioning
timeFrame: 6 months
measure: Patient Satisfaction with Medical Care
timeFrame: 6 months
Other outcomes:
Locations:
city: Be'er-Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Yacov Ezra, MD
role: PRINCIPAL_INVESTIGATOR
References: