Back to resultsComparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
"Re Spine"
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Low back pain
Exclusion Criteria:
- None
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
"Re Spine" Mattress
Physiotherapy
Arm Description
Adults suffering low back pain will treat their low back pain using the "Re Spine" mattress
Adults suffering low back pain will treat their low back pain using conventional physiotherapy protocols
Outcomes
Primary Outcome Measures
Reduction in low back pain
Pain levels will be measured using the Visual Analogue Scale (VAS) on the first day of study and 6 weeks, and 3 months after treatment at end of study.
Effectiveness of treatment
Effectiveness of treatment will be assessed based on Oswestry Disability Index and Mini Sleep Questionnaire on the first day of study and 6 weeks, and 3 months after treatment at end of study.
Secondary Outcome Measures
Full Information
NCT ID
NCT03135704
First Posted
April 20, 2017
Last Updated
May 3, 2017
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03135704
Brief Title
Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
Official Title
Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe 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
Yes
5. Study Description
Brief Summary
The objective of this study is to assess the effectiveness of the "Re Spine" mattress, which was designed as an alternative to physiotherapy in the treatment of low back pain (LBP).
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Re Spine" Mattress
Arm Type
Active Comparator
Arm Description
Adults suffering low back pain will treat their low back pain using the "Re Spine" mattress
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Adults suffering low back pain will treat their low back pain using conventional physiotherapy protocols
Intervention Type
Device
Intervention Name(s)
"Re Spine"
Intervention Description
A new mattress design made of special materials and built in a specially shaped structure that allows the brain to relax the body and dissipate tension accumulated on the lumbar spine.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Usual protocol for treatment of low back pain
Primary Outcome Measure Information:
Title
Reduction in low back pain
Description
Pain levels will be measured using the Visual Analogue Scale (VAS) on the first day of study and 6 weeks, and 3 months after treatment at end of study.
Time Frame
1 day, 6 weeks, 3 months
Title
Effectiveness of treatment
Description
Effectiveness of treatment will be assessed based on Oswestry Disability Index and Mini Sleep Questionnaire on the first day of study and 6 weeks, and 3 months after treatment at end of study.
Time Frame
1 day, 6 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low back pain
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eyal Behrbelk, Dr
Phone
972-58-4747052
Email
EyalB@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Behrbalk, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Alony, RN
Phone
972-52-3747719
Email
ilanaa@hy.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
We'll reach out to this number within 24 hrs