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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
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|
|Hillel Yaffe Medical Center|
|Hadera, Israel, 38100|
|Contact: Ilana Alony, RN 972-52-3747719 email@example.com|
|Principal Investigator:||Eyal Behrbalk, MD||Hillel Yaffe Medical Center|