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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
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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).

Condition or disease Intervention/treatment Phase
Low Back Pain Device: "Re Spine" Other: Physiotherapy Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low back pain

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Eyal Behrbelk, Dr 972-58-4747052 EyalB@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: Ilana Alony, RN    972-52-3747719    ilanaa@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Eyal Behrbalk, MD Hillel Yaffe Medical Center
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations