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

S

Soroka University Medical Center

Status

Terminated

Conditions

Chronic Headache
Chronic Pain
Neurasthenia

Treatments

Other: Medical and Psychological treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02141568
SOR-016312-CTIL
SCRC12014 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Intervention Group for Prospective Study
Experimental group
Description:
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.
Treatment:
Other: Medical and Psychological treatment
No Intervention
No Intervention group
Description:
Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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