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

Sheba Medical Center

Status: Unknown

Conditions: Low Back Pain

Treatments: Device: Xiaomi Mi Band

Study type: Interventional

Funder types: Other

Identifiers

NCT02830607

SHEBA-16-3206-HB-CTIL

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Xiaomi Mi Band

Experimental group

Description:

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.

Treatment:

Device: Xiaomi Mi Band