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

Chronic Pain Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02141568
• Other study ID #: SOR-016312-CTIL
• Secondary ID: SCRC12014
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 26, 2019

Study information

• Verified date: March 2019
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 26, 2019
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Headache
• Chronic Pain
• Headache
• Headache Disorders
• Medically Unexplained Symptoms
• Neurasthenia

Intervention

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).

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life	Changes in the Short Form 36 Health Survey (SF-36)	6 months
Secondary	Cost-effectiveness	Total cost associated with healthcare due to intervention	12 months
Secondary	Anxiety	Changes in the State-Trait Anxiety Inventory (STAI)	6 months
Secondary	Depression	Changes in the Patient Health Questionnaire 9 (PHQ-9)	6 months
Secondary	Catastrophization	Changes in the Pain Catastrophization Scale (PCS)	6 months
Secondary	Locus of Control	Changes in the Health Locus of Control Survey (H-LOC)	6 months
Secondary	Existence of Symptoms	Changes in the Patient Health Questionnaire 15 (PHQ-15)	6 months
Secondary	Pain Symptoms and Functioning	Changes in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)	6 months
Secondary	Patient Satisfaction with Medical Care	Changes in the Low Threshold Experience Survey (LTES)	6 months