Comparison of Two Treatments for Low Back Pain: “Re Spine” vs. Physiotherapy

Overview

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).

Full Title of Study: “Comparison of Two Treatments for Low Back Pain: “Re Spine” vs. Physiotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2019

Interventions

  • 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.
  • Other: Physiotherapy
    • Usual protocol for treatment of low back pain

Arms, Groups and Cohorts

  • Active Comparator: “Re Spine” Mattress
    • Adults suffering low back pain will treat their low back pain using the “Re Spine” mattress
  • Active Comparator: Physiotherapy
    • Adults suffering low back pain will treat their low back pain using conventional physiotherapy protocols

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Low back pain Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hillel Yaffe Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eyal Behrbalk, MD, Principal Investigator, Hillel Yaffe Medical Center
  • Overall Contact(s)
    • Eyal Behrbelk, Dr, 972-58-4747052, EyalB@hy.health.gov.il

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