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

Radiancy

Status: Completed

Conditions: Mild to Moderate Chronic Low Back Pain

Treatments: Device: no!no!Back

Study type: Interventional

Funder types: Industry

Identifiers

NCT01620281

LBP-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Immediate treatment (IT)

Experimental group

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.

Treatment:

Device: no!no!Back

Waiting List Control (WLC)

Other group

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.

Treatment:

Device: no!no!Back