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

NCT ID: NCT03135704

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"Re Spine" Mattress

Adults suffering low back pain will treat their low back pain using the "Re Spine" mattress

Group Type ACTIVE_COMPARATOR

"Re Spine"

Intervention Type DEVICE

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.

Physiotherapy

Adults suffering low back pain will treat their low back pain using conventional physiotherapy protocols

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

Usual protocol for treatment of low back pain

Interventions

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"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.

Intervention Type DEVICE

Physiotherapy

Usual protocol for treatment of low back pain

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Low back pain

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eyal Behrbalk, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eyal Behrbelk, Dr

Role: CONTACT

972-58-4747052

Facility Contacts

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Ilana Alony, RN

Role: primary

972-52-3747719

Other Identifiers

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HYMC-0025-17

Identifier Type: -

Identifier Source: org_study_id

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