Mild to Moderate Chronic Low Back PainLBP-1NCT01620281

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

A study testing no!no!Back in people with Mild to Moderate Chronic Low Back Pain, run by Radiancy at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Mild to Moderate Chronic Low Back Pain
What is being tested?: no!no!Back
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteIsrael
Study dates: Jun 2012to Feb 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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 locations and contacts

1 site in 1 country.

Israel1 site

Koren Physiotherapy Institute
Mevaseret Zion

Other trials in Israel

About this study

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

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.

Read the 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.

Conditions: Mild to Moderate Chronic Low Back Pain
Being tested: no!no!Back
Keywords: Back Pain
Medical subject headings: Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no!no!BackDevice
Self treatments daily for 3 weeks, in up to three 10-minutes sessions

Study groups in NCT01620281
Study group	Role	What they receive
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. Receives: 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. Receives: Device: no!no!Back

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 3 weeks

Secondary outcomes (2)

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).
Measured: 3,6 weeks
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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Feb 2013

First posted15 Jun 2012 (estimated)
Study startJun 2012
Primary completionOct 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild to Moderate Chronic Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01620281
Sponsor's protocol ID: LBP-1
Acronym: LBP-1
Status last verified: Aug 2013
First submitted: 13 Jun 2012
Last updated: 6 Aug 2013
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 25280603

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study
ClinicalTrials.gov ID: NCT01620281
Acronym / sponsor ID: LBP-1 / LBP-1
Conditions: Mild to Moderate Chronic Low Back Pain
Keywords: Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: RadiancyIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Oct 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 15 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate treatment (IT)	Experimental	Device: no!no!BackSubjects 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.
Waiting List Control (WLC)	Other	Device: no!no!BackThe 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no!no!BackSelf treatments daily for 3 weeks, in up to three 10-minutes sessions	Device	Immediate treatment (IT), Waiting List Control (WLC)

Primary outcome

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

2 secondary outcomes

Change in functional health status by ODI
Time frame: 3,6 weeks
Subject satisfaction
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
Derived from this study: PubMed 25280603Gavish 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lilach Gavish, PhD study director

Friedman Skin & Laser Center

David J Friedman, MD principal investigator

Friedman Skin & Laser Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing no!no!Back in people with Mild to Moderate Chronic Low Back Pain, run by Radiancy at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain level after 3 weeks compared to baseline (before treatment) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01620281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2013.