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)

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Chronic Headache; Neurasthenia
• Intervention / Treatment: Other: Medical and Psychological treatment

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er-Sheva, Israel, 84101
    • Soroka University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group for Prospective Study; 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.	Other: Medical 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).
No Intervention: No Intervention; Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life	Changes in the Short Form 36 Health Survey (SF-36)	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: Yacov Ezra, MD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 15, 2014
• First Posted (Estimate): May 19, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Cost-effective; Unexplained Medical Symptoms; Frequent Attenders
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Somatoform Disorders; Chronic Pain; Headache; Medically Unexplained Symptoms; Headache Disorders; Neurasthenia
• Other Study ID Numbers: SOR-016312-CTIL; SCRC12014 (Other Identifier: Soroka Clinical Research Center (SCRC))