NeurastheniaNCT02141568
Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)
A study testing Medical and Psychological treatment in people with Neurasthenia and Chronic Pain, run by Soroka University Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurasthenia, Chronic Pain, Chronic Headache
- What is being tested?
- Medical and Psychological treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to 26 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women
- Age 18 or higher
- Treated at the Functional Neurology clinic at Soroka UMC
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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:
- 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.
- 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
- A decrease in expense rates and use of medical services
- An increase in patient satisfaction
- An increase in patient-reported health and quality of life
- Conditions
- Neurasthenia, Chronic Pain, Chronic Headache
- Being tested
- Medical and Psychological treatment
- Keywords
- Cost-effective, Unexplained Medical Symptoms, Frequent Attenders
- Medical subject headings
- Neurasthenia, Chronic Pain, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical and Psychological treatmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medical and Psychological treatment |
| No Intervention | No intervention | Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
Changes in the Short Form 36 Health Survey (SF-36)
Measured: 6 months
Secondary outcomes (8)
Cost-effectiveness
Total cost associated with healthcare due to intervention
Measured: 12 months
Anxiety
Changes in the State-Trait Anxiety Inventory (STAI)
Measured: 6 months
Depression
Changes in the Patient Health Questionnaire 9 (PHQ-9)
Measured: 6 months
Catastrophization
Changes in the Pain Catastrophization Scale (PCS)
Measured: 6 months
Locus of Control
Changes in the Health Locus of Control Survey (H-LOC)
Measured: 6 months
Existence of Symptoms
Changes in the Patient Health Questionnaire 15 (PHQ-15)
Measured: 6 months
Pain Symptoms and Functioning
Changes in the Short Form Treatment Outcomes in Pain Survey (S-TOPS)
Measured: 6 months
Patient Satisfaction with Medical Care
Changes in the Low Threshold Experience Survey (LTES)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completion26 Feb 2019
Why it stopped: Low patient compliance and dropout during the period defined for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurastheniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yacov Ezra, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141568
- Sponsor's protocol ID
- SOR-016312-CTIL
- Other IDs
- SCRC12014
- Status last verified
- Mar 2019
- First submitted
- 15 May 2014
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02141568
- Acronym / sponsor ID
- SOR-016312-CTIL
- Conditions
- Neurasthenia, Chronic Pain, Chronic Headache
- Keywords
- Cost-effective, Unexplained Medical Symptoms, Frequent Attenders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient compliance and dropout during the period defined for the study
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- A decrease in expense rates and use of medical services
- An increase in patient satisfaction
- An increase in patient-reported health and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group for Prospective Study | Experimental | Other: Medical and Psychological treatmentIntervention: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women
- Age 18 or higher
- Treated at the Functional Neurology clinic at Soroka UMC
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical and Psychological treatmentMedical 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). | Other | Intervention Group for Prospective Study |
Primary outcome
Health Related Quality of Life
Time frame: 6 months
Changes in the Short Form 36 Health Survey (SF-36)
8 secondary outcomes
Cost-effectiveness
Time frame: 12 months
Anxiety
Time frame: 6 months
Depression
Time frame: 6 months
Catastrophization
Time frame: 6 months
Locus of Control
Time frame: 6 months
Existence of Symptoms
Time frame: 6 months
Pain Symptoms and Functioning
Time frame: 6 months
Patient Satisfaction with Medical Care
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Low patient compliance and dropout during the period defined for the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yacov Ezra, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical and Psychological treatment in people with Neurasthenia and Chronic Pain, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low patient compliance and dropout during the period defined for the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.