The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)

NCT02155283 | Completed Results

• 1 other identifier: LBP-2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive motion home-use device in relieving low back pain, improving proprioception (balance and fall prevention) and improving the symmetry of muscle function on either side of the spine.

Conditions

Low Back Pain

Keywords

Chronic Low Back Pain; Mild-to-Moderate Chronic Low Back Pain; Continuous Passive Motion Devices

Outcome Measures

Primary Outcomes (1)

• Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)

  Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.

  3 weeks

Secondary Outcomes (4)

• Change in Proprioception and Vestibular Function.

  3 weeks, 4 weeks

• Change in Functional Health Status by ODI

  3 weeks, 4 weeks

• Change in Symmetry of Muscle Function on Either Side of the Spine

  3 weeks, 4 weeks

• Change in Heart Rate Variability (and the Autonomic System)

  3 weeks, 4 weeks

Other Outcomes (1)

• Change in Amount of Pain Determined by the NRS at the 1-week Follow-up After the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)

  4 weeks

Study Arms (1)

Treatment Continuous Passive Motion

OTHER

Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)

Device: Continuous Passive Motion

Interventions

Continuous Passive Motion DEVICE

Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day

Also known as: Kyrobak

Treatment Continuous Passive Motion

Eligibility Criteria

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

You may qualify if:

• Male or female, age 18 or older
• 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 causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome (radiating nerve pain from the spine such as sciatica), cauda equinal syndrome (serious neurological disorder where the spinal nerve roots are compressed which can cause).
• Weight in excess of 265 lbs. (120.4 kg)
• Pregnant or breastfeeding
• 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 tumor
• 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
• Any litigation for low back pain
• Prolonged use of corticosteroids (i.e. used for 3 months or more)
• Present use of prescription pain medication (i.e. Percocet®, Oxycodone, Vicodin®, etc.)
• Physical disability that prevents the subject to lie down/get up
• Drug abuse, immunosuppression, HIV

Sponsors & Collaborators

• Radiancy: lead

Study Sites (1)

New Heights Chiropractic

New York, New York, 10033, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Motion Therapy, Continuous Passive

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations

Results Point of Contact

• Title: Dr. Daniele Perl-Treves, Clinical Director
• Organization: Radiancy Ltd

daniele@radiancy.com

972-97757556

Study Officials

• Steven G Geanopulos, DC

  New Heights Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: June 4, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2014-06

Locations

US (1)