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 : Unknown
Verified April 2018 by Dr. Wiam Welly, Sheba Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : July 13, 2016
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: Xiaomi Mi Band||Not Applicable|
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|
|Actual Study Start Date :||December 21, 2017|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2019|
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
- 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).
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
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|Principal Investigator:||Haim Berkenstadt, MD||Sheba Medical Center|