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

Not Applicable

• Conditions: Low Back Pain

• Registration Number: NCT03135704
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-26
• Status Verified: 2017-05
• Study Start: 2017-05
• Study First Posted: 2017-05-01
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Low back pain

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in low back pain	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	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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel