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

NCT01620281 | Completed

• 1 other identifier: LBP-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Chronic Low Back Pain

Keywords

Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

  3 weeks

Secondary Outcomes (2)

• Change in functional health status by ODI

  3,6 weeks

• Subject satisfaction

  6 weeks

Study Arms (2)

Immediate treatment (IT)

EXPERIMENTAL

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

Waiting List Control (WLC)

OTHER

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

Interventions

no!no!Back DEVICE

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

Immediate treatment (IT); Waiting List Control (WLC)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radiancy: lead

Study Sites (1)

Koren Physiotherapy Institute

Mevaseret Zion, Israel

Location

Related Publications (1)

• 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.

  PMID: 25280603 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lilach Gavish, PhD

  Friedman Skin & Laser Center

  STUDY DIRECTOR

• David J Friedman, MD

  Friedman Skin & Laser Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: August 6, 2013

Record last verified: 2013-08

Locations

IL (1)