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

Low Back Pain Clinical Trial

— LBP-2  

Official title:

The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155283
• Other study ID #: LBP-2
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: June 28, 2015
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Radiancy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The Kyrobak is an electrically operated, continuous passive motion device including a platform that performs angular oscillations. The Kyrobak is used at home as an aid to relieve mild-to-moderate low back pain.

The study is designed to evaluate the efficacy of daily home use of the Kyrobak for 3 weeks and to assess the sustained efficacy 1 week later.

The evaluation will include the level of pain using the numerical rating scale (NRS), Digital Posturography, Heart Rate Variability (HRV), Static Surface Electromyography (SEMG), a condition-specific low back pain disability status by the Oswestry Disability Index (ODI) and subject satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Any other condition which in the physician's opinion would make it unsafe for the subject to be treated.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Continuous Passive Motion
Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day

Locations

Country	Name	City	State
United States	New Heights Chiropractic	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Radiancy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	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.	4 weeks	No
Primary	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	No
Secondary	Change in Proprioception and Vestibular Function.	Gather information regarding: Balance and Fall Prevention using digital posturography	3 weeks, 4 weeks	No
Secondary	Change in Functional Health Status by ODI	Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)	3 weeks, 4 weeks	No
Secondary	Change in Symmetry of Muscle Function on Either Side of the Spine	Gather information regarding: Symmetry of muscle function about the spine using static surface electromyography (SEMG)	3 weeks, 4 weeks	No
Secondary	Change in Heart Rate Variability (and the Autonomic System)	Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV).	3 weeks, 4 weeks	No