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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135704
Enrollment
60
Registered
2017-05-01
Start date
2017-05-31
Completion date
2019-01-31
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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).

Interventions

DEVICERe 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.

OTHERPhysiotherapy

Usual protocol for treatment of low back pain

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Low back pain

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Reduction in low back pain1 day, 6 weeks, 3 monthsPain 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 treatment1 day, 6 weeks, 3 monthsEffectiveness 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.

Countries

Israel

Contacts

Primary ContactEyal Behrbelk, Dr
EyalB@hy.health.gov.il972-58-4747052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026