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Wearable Devices to Monitor Efficacy of Epidural Steroid Injection in Patients With Low Back Pain

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ClinicalTrials.gov Identifier: NCT02830607
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2016
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Wiam.abed-alwelye, Sheba Medical Center

Brief Summary:
Low back pain (Lower Back Pain ) is extremely common , affecting more than 80 % of the general population in the modern world , one is considered the most common cause of disability in people under the age of 45. Lower back pain represents a social problem and substantial economies in Western countries , also considered a first cause for orthopedic consultation. In recent decades , a number of methods developed for assessing the functional status of patients with low back pain , and over twenty -five generic methods available today for use in pain clinics , orthopedic clinics and in clinical trials A large part of the measures used to monitor the response of patients to treatment of low back pain based on self-report questionnaires ,on patients' pain intensity , quality of life measures , and functional status In recent years a number of wearable monitoring devices designed to help people assess the progress of sports activity , by measuring steps , pulse , and quality of sleep , in this study we will use these measures to assess treatment efficacy after steroid injection to the epidural space in patients with low back pain . And compare the results to those taken from subjective self-report questionnaires .

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Xiaomi Mi Band Not Applicable

Detailed Description:

Low back pain (Lower Back Pain) is extremely common, affecting more than 80% of the general population in the modern world, one is considered the most common cause of disability in people under the age of 45. 2 Lower back pain represents a social problem and substantial economies in Western countries, such as also considered a first cause orthopedic advice ahead. 3 Over the past decades, developed a number of methods for assessing the functional status of patients with low back pain, 4-7 and over twenty-five generic methods available today for use in pain clinics, orthopedic clinics and in clinical trials. 8 A large part of the measures used to monitor the response of patients to treat low back pain based on self-report questionnaires on patients' pain intensity, quality of life measures, and functional status.measures which relate to such measures - reduction of pain, reduction in the consumption of medication relieve pain, improved mood, improved daily function, improved sleep patterns, back in daily life and work, a reduction in the consumption of health system resources, and reduction in disability benefits, sick leave, early retirement, and more. The existence of multiple assessment tools of this type suggests that there is no a single tool valid and reliable for assessing the severity of low back pain and its response to treatment. In addition, there is a problematic depending on the patient's self-report is subjective and often biased because of the possibility of secondary gain illness.

In recent years there has been great progress in the use of technologies of wearable monitoring both by the general population as part of the tracking of daily living and sports, as well as in a clinical setting. The use of cheap and simple devices give the user information about the number of steps performed during the day measuring heart rate and sleep quality .

In the present work the investigators will make use of wearable and affordable device that measures a number of steps and sleep quality monitoring recovery after epidural steroid injection for patients with low back pain. The indices will be accepted through this monitoring will be compared with subjective reports of participants and physician's assessment about the success of the treatment. investigators Will use the wearable monitoring type Xiaomi Mi Band for measuring steps and sleep quality the device was chosen because it is cheap, easy to use, has long battery life (two weeks between charges), and the participants can continue to wear it every hour of the day and while bathing. as a measure of subjective filled questionnaire by the participants,the investigators selected the Oswestry Disability Index (ODI) . This questionnaire addresses aspects of wider life of the patient and is composed of 10 sections: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, socializing, travel and employment.Each section includes values from 0 to 5 , with higher values representing higher functional limitation . The final score is obtained using a standard scoring .


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Using Wearable Monitoring Devices for Assessing Efficacy of Epidural Steroid Injection in Patients With Low Back Pain
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Xiaomi Mi Band
participants will wear Xiaomi Mi Band .the device measures their daily steps number before and after epidural steroid injection for treatment of low back pain.
Device: Xiaomi Mi Band
participants will wear Xiaomi Mi Band as assessment tool for recovery after epidural steroid injection for treatment of low back pain



Primary Outcome Measures :
  1. number of steps . [ Time Frame: from the day of making the decision for treatment until four weeks after treatment. ]
    the investigators will be using the xiaomi mi band to measure the number of steps the participants make daily. from the day of making the decision for treatment (steroid injection for epidural space) until four weeks after treatment. this measures will be compared to the score taken from Oswestry disability index (ODI) Before treatment and on day 3,7,14 and 28 after treatment. Evaluating the treatment response by the treating pain physician using a scale from zero to ten, where (zero no response an 10 great response).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • After Ethics Committee approval and consent to participate in research. self- aware 40 patients aged 18-60 Hebrew, speakers who come for the first time to a pain clinic for the treatment with epidural steroid injection due to low back pain and express their consent to participate in the study

Exclusion Criteria:

  • the study will not include patients who received steroid injection to the epidural space as part of previous treatment, the study will not include morbid obese patients B.M.I over 30, patients with symptomatic coronary artery disease, patients with known osteoarthritis that or any orthopedic disease that limit their walking capacity, C.O.P.D patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830607


Locations
Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Haim Berkenstadt, MD Sheba Medical Center

Publications:
Responsible Party: Dr. Wiam.abed-alwelye, Anesthesiology resident, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02830607     History of Changes
Other Study ID Numbers: SHEBA-16-3206-HB-CTIL
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms