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

Not Applicable

Terminated

• Conditions: Chronic Pain; Chronic Headache; Neurasthenia
• Interventions: Other: Medical and Psychological treatment

• Registration Number: NCT02141568
• Lead Sponsor: Soroka University Medical Center

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

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-19
• Study Start: 2016-01
• Primary Completion: 2017-01
• Study Completion: 2019-02-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group for Prospective Study	Medical and Psychological treatment	Intervention: Medical and psychological treatment at the Soroka UMC "functional neurology" outpatient clinic. Treatment will be conducted by a multidisciplinary staff. Patients will undergo an initial meeting with a neurologist and afterwards will be directed to other members of the team (psychologist, physical therapist) on a case by case basis.

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life	6 months	Changes in the Short Form 36 Health Survey (SF-36)

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	12 months	Total cost associated with healthcare due to intervention
Locus of Control	6 months	Changes in the Health Locus of Control Survey (H-LOC)
Existence of Symptoms	6 months	Changes in the Patient Health Questionnaire 15 (PHQ-15)
Pain Symptoms and Functioning	6 months	Changes in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)
Anxiety	6 months	Changes in the State-Trait Anxiety Inventory (STAI)
Depression	6 months	Changes in the Patient Health Questionnaire 9 (PHQ-9)
Catastrophization	6 months	Changes in the Pain Catastrophization Scale (PCS)
Patient Satisfaction with Medical Care	6 months	Changes in the Low Threshold Experience Survey (LTES)

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Be'er-Sheva, Israel