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Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02141568
Enrollment
15
Registered
2014-05-19
Start date
2016-01-31
Completion date
2019-02-26
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Headache, Chronic Pain, Neurasthenia

Keywords

Cost-effective, Unexplained Medical Symptoms, Frequent Attenders

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

Interventions

OTHERMedical and Psychological treatment

Medical and psychological treatment by the staff of the functional neurology clinic at Soroka UMC. This treatment will include an initial visit to the staff neurologist and further multidisciplinary treatment as per his decision (the team includes a psychologist and a physical therapist).

Sponsors

Soroka University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health Related Quality of Life6 monthsChanges in the Short Form 36 Health Survey (SF-36)

Secondary

MeasureTime frameDescription
Anxiety6 monthsChanges in the State-Trait Anxiety Inventory (STAI)
Depression6 monthsChanges in the Patient Health Questionnaire 9 (PHQ-9)
Catastrophization6 monthsChanges in the Pain Catastrophization Scale (PCS)
Cost-effectiveness12 monthsTotal cost associated with healthcare due to intervention
Existence of Symptoms6 monthsChanges in the Patient Health Questionnaire 15 (PHQ-15)
Pain Symptoms and Functioning6 monthsChanges in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)
Patient Satisfaction with Medical Care6 monthsChanges in the Low Threshold Experience Survey (LTES)
Locus of Control6 monthsChanges in the Health Locus of Control Survey (H-LOC)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026