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

Primary Purpose

Mild to Moderate Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
no!no!Back
Sponsored by
Radiancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Chronic Low Back Pain focused on measuring Back Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Koren Physiotherapy Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate treatment (IT)

Waiting List Control (WLC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in pain level after 3 weeks compared to baseline (before treatment)
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

Secondary Outcome Measures

Change in functional health status by ODI
Functional health status will be determined by the ODI questionnaire filled by the subject (10 multi-choice questions, takes 5 minutes to answer).
Subject satisfaction
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.

Full Information

First Posted
June 13, 2012
Last Updated
August 4, 2013
Sponsor
Radiancy
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1. Study Identification

Unique Protocol Identification Number
NCT01620281
Brief Title
The Efficacy of the no!no!Back for Chronic Low Back Pain
Acronym
LBP-1
Official Title
The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiancy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Chronic Low Back Pain
Keywords
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate treatment (IT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting List Control (WLC)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
no!no!Back
Intervention Description
Self treatments daily for 3 weeks, in up to three 10-minutes sessions
Primary Outcome Measure Information:
Title
Change in pain level after 3 weeks compared to baseline (before treatment)
Description
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
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in functional health status by ODI
Description
Functional health status will be determined by the ODI questionnaire filled by the subject (10 multi-choice questions, takes 5 minutes to answer).
Time Frame
3,6 weeks
Title
Subject satisfaction
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilach Gavish, PhD
Organizational Affiliation
Friedman Skin & Laser Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David J Friedman, MD
Organizational Affiliation
Friedman Skin & Laser Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koren Physiotherapy Institute
City
Mevasseret-Zion
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
25280603
Citation
Gavish L, Barzilay Y, Koren C, Stern A, Weinrauch L, Friedman DJ. Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study. Physiotherapy. 2015 Mar;101(1):75-81. doi: 10.1016/j.physio.2014.06.003. Epub 2014 Jul 28.
Results Reference
derived

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The Efficacy of the no!no!Back for Chronic Low Back Pain

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