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| ID | Type | Description | Link |
|---|---|---|---|
| SCRC12014 | Other Identifier | Soroka Clinical Research Center (SCRC) |
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Low patient compliance and dropout during the period defined for the study
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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.
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:
Expected Results
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group for Prospective Study | Experimental | 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. |
|
| No Intervention | No Intervention | Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical and Psychological treatment | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | Changes in the Short Form 36 Health Survey (SF-36) | 6 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yacov Ezra, MD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Beersheba | 84101 | Israel |
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| ID | Term |
|---|---|
| D009440 | Neurasthenia |
| D059350 | Chronic Pain |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |