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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radiancy
ClinicalTrials.gov Identifier:
NCT01620281
First received: June 13, 2012
Last updated: August 4, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Mild to Moderate Chronic Low Back Pain
Device: no!no!Back

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Radiancy:

Primary Outcome Measures:
  • Change in pain level after 3 weeks compared to baseline (before treatment) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3,6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620281

Locations
Israel
Koren Physiotherapy Institute
Mevasseret-Zion, Israel
Sponsors and Collaborators
Radiancy
Investigators
Study Director: Lilach Gavish, PhD Friedman Skin & Laser Center
Principal Investigator: David J Friedman, MD Friedman Skin & Laser Center
  More Information

No publications provided

Responsible Party: Radiancy
ClinicalTrials.gov Identifier: NCT01620281     History of Changes
Other Study ID Numbers: LBP-1
Study First Received: June 13, 2012
Last Updated: August 4, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Radiancy:
Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014