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Completed

NCT Number: NCT01620281

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

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.

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Key information

Conditions

Mild to Moderate Chronic Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koren Physiotherapy Institute

Mevaseret Zion, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

no!no!Back

Device

Self treatments daily for 3 weeks, in up to three 10-minutes sessions

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Radiancy

Industry

Registry information

Official study title

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

Acronym: LBP-1

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 15, 2012
Registry last updated
Aug 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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