NCT03135704

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started May 2017

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

April 20, 2017

Last Update Submit

May 3, 2017

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • Reduction in low back pain

    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.

    1 day, 6 weeks, 3 months

  • Effectiveness of treatment

    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.

    1 day, 6 weeks, 3 months

Study Arms (2)

"Re Spine" Mattress

ACTIVE COMPARATOR

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

Device: "Re Spine"

Physiotherapy

ACTIVE COMPARATOR

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

Other: Physiotherapy

Interventions

"Re Spine"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.

"Re Spine" Mattress
PhysiotherapyOTHER

Usual protocol for treatment of low back pain

Physiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low back pain

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Eyal Behrbalk, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Behrbelk, Dr

CONTACT

972-58-4747052EyalB@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

May 1, 2017

Study Start

May 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)