The Efficacy of the no!no!Back for Chronic Low Back Pain (LBP-1)

August 4, 2013 updated by: Radiancy

The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study

This pilot study is designed to evaluate the efficacy of the no!no!Back continuous passive motion device in relieving of mild to moderate non-specific low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The no!no!Back is an electrically operated, continuous passive motion device including a platform that performs angular oscillations. The device is intended to be used at home as an accessory for relieving of mild to moderate low back pain (LBP).

This study is designed to determine the efficacy of daily use home use with the no!no!Back device during 3 weeks and to assess the sustained effect 3 weeks later. Up to 30 subjects will be randomized to either an immediate treatment (IT) group that will receive the no!no!Back device at the baseline visit, or to the wait-list control (WLC) group that will receive the device 3 weeks later. The evaluation will include level of pain using the numerical rating scale (NRS), functional health status by Oswestry disability index (ODI), and subject satisfaction.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Mevasseret-Zion, Israel
        • Koren Physiotherapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age 18 or more
  • Level of pain - mild to moderate low back pain (≤5 NRS pain)
  • Chronic - symptoms must have been present for at least 12 weeks or more.
  • Location - lower tip of scapula to back of pelvis
  • Etiology - non-specific

Exclusion Criteria:

  • Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
  • Pregnant or lactating
  • Recent history of violent trauma
  • History of previous back surgery
  • Constant progressive, non mechanical pain (no relief with bed rest)
  • Chronic pain other than low back pain
  • Past medical history of malignant tumour
  • Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
  • Mental disorder that would lead to difficulty in questionnaire completion
  • Current or future litigation for low back pain
  • Prolonged use of corticosteroids
  • Physical disability that prevents the subject to lie down/get up
  • Drug abuse, immunosuppression, HIV
  • Any other condition which in the physician's opinion would make it unsafe for the subject to be treated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment (IT)
Subjects from this group will receive the device immediately. Subjects will be instructed to treat themselves daily for 3 weeks, in up to three 10-minutes sessions. All subjects will receive a diary to record details of the daily use of the device (time of day, position of legs, and number of daily uses), degree of pain, a weekly ODI questionnaire, and record of any back/pain related events. After 3 weeks the subjects from the IT group will return the device and at 6 weeks they will visit again for the final evaluation.
Device: no!no!Back
Self treatments daily for 3 weeks, in up to three 10-minutes sessions
Other: Waiting List Control (WLC)
The WLC group will go through the same evaluations at the same time intervals but will begin treatments 3 weeks later during which they will fill the diary daily but not use the device.
Device: no!no!Back
Self treatments daily for 3 weeks, in up to three 10-minutes sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain level after 3 weeks compared to baseline (before treatment)
Time Frame: 3 weeks
Pain level will be scored by the subject using a numerical rating scone on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional health status by ODI
Time Frame: 3,6 weeks
Functional health status will be determined by the ODI questionnaire filled by the subject (10 multi-choice questions, takes 5 minutes to answer).
3,6 weeks
Subject satisfaction
Time Frame: 6 weeks
The subject will be verbally asked to grade his/her overall satisfaction according to the satisfaction assessment scale based on a 5-point Likert scale detailed in Table 3 where 0 represents very unsatisfied and 4 represents very satisfied. In addition the subject will fill a questionnaire.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 4, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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