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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Xiaomi Mi Band
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xiaomi Mi Band

Arm 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.

Outcomes

Primary Outcome Measures

number of steps .
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).

Secondary Outcome Measures

Full Information

First Posted
June 18, 2016
Last Updated
April 30, 2018
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02830607
Brief Title
Wearable Devices to Monitor Efficacy of Epidural Steroid Injection in Patients With Low Back Pain
Official Title
Using Wearable Monitoring Devices for Assessing Efficacy of Epidural Steroid Injection in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xiaomi Mi Band
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Xiaomi Mi Band
Intervention Description
participants will wear Xiaomi Mi Band as assessment tool for recovery after epidural steroid injection for treatment of low back pain
Primary Outcome Measure Information:
Title
number of steps .
Description
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).
Time Frame
from the day of making the decision for treatment until four weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Berkenstadt, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26733594
Citation
Li RT, Kling SR, Salata MJ, Cupp SA, Sheehan J, Voos JE. Wearable Performance Devices in Sports Medicine. Sports Health. 2016 Jan-Feb;8(1):74-8. doi: 10.1177/1941738115616917. Epub 2015 Nov 11.
Results Reference
background
PubMed Identifier
26545038
Citation
Knowles LM, Skeath P, Jia M, Najafi B, Thayer J, Sternberg EM. New and Future Directions in Integrative Medicine Research Methods with a Focus on Aging Populations: A Review. Gerontology. 2016;62(4):467-76. doi: 10.1159/000441494. Epub 2015 Nov 7.
Results Reference
background
PubMed Identifier
11175676
Citation
Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776. Erratum In: Phys Ther. 2008 Jan;88(1):138-9.
Results Reference
background
PubMed Identifier
20064820
Citation
Longo UG, Loppini M, Denaro L, Maffulli N, Denaro V. Rating scales for low back pain. Br Med Bull. 2010;94:81-144. doi: 10.1093/bmb/ldp052. Epub 2010 Jan 10.
Results Reference
background
PubMed Identifier
15626993
Citation
Grotle M, Brox JI, Vollestad NK. Functional status and disability questionnaires: what do they assess? A systematic review of back-specific outcome questionnaires. Spine (Phila Pa 1976). 2005 Jan 1;30(1):130-40.
Results Reference
background
PubMed Identifier
14699281
Citation
Luo X, Pietrobon R, Sun SX, Liu GG, Hey L. Estimates and patterns of direct health care expenditures among individuals with back pain in the United States. Spine (Phila Pa 1976). 2004 Jan 1;29(1):79-86. doi: 10.1097/01.BRS.0000105527.13866.0F.
Results Reference
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Wearable Devices to Monitor Efficacy of Epidural Steroid Injection in Patients With Low Back Pain

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