Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03135704 |
Recruitment Status : Unknown
Verified May 2017 by Hillel Yaffe Medical Center.
Recruitment status was: Not yet recruiting
First Posted : May 1, 2017
Last Update Posted : May 8, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain | Device: "Re Spine" Other: Physiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy |
Estimated Study Start Date : | May 2017 |
Estimated Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | January 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: "Re Spine" Mattress
Adults suffering low back pain will treat their low back pain using the "Re Spine" mattress
|
Device: "Re Spine"
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. |
Active Comparator: Physiotherapy
Adults suffering low back pain will treat their low back pain using conventional physiotherapy protocols
|
Other: Physiotherapy
Usual protocol for treatment of low back pain |
- Reduction in low back pain [ Time Frame: 1 day, 6 weeks, 3 months ]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 [ Time Frame: 1 day, 6 weeks, 3 months ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Low back pain
Exclusion Criteria:
- None

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): NCT03135704
Contact: Eyal Behrbelk, Dr | 972-58-4747052 | EyalB@hy.health.gov.il |
Israel | |
Hillel Yaffe Medical Center | |
Hadera, Israel, 38100 | |
Contact: Ilana Alony, RN 972-52-3747719 ilanaa@hy.health.gov.il |
Principal Investigator: | Eyal Behrbalk, MD | Hillel Yaffe Medical Center |
Responsible Party: | Hillel Yaffe Medical Center |
ClinicalTrials.gov Identifier: | NCT03135704 |
Other Study ID Numbers: |
HYMC-0025-17 |
First Posted: | May 1, 2017 Key Record Dates |
Last Update Posted: | May 8, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Back Pain Low Back Pain Pain Neurologic Manifestations |