Trial Outcomes & Findings for The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2) (NCT NCT02155283)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

3 weeks

Results posted on

2015-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Continuous Passive Motion Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
Overall Study STARTED	16
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Continuous Passive Motion Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Continuous Passive Motion n=16 Participants Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
Age, Continuous	53.75 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: Completers per protocol

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.

Outcome measures

Outcome measures
Measure	Treatment Continuous Passive Motion n=9 Participants Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)	-2.87 units on a scale Standard Deviation 1.71

SECONDARY outcome

Timeframe: 3 weeks, 4 weeks

Gather information regarding: Balance and Fall Prevention using digital posturography

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks, 4 weeks

Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks, 4 weeks

Gather information regarding: Symmetry of muscle function about the spine using static surface electromyography (SEMG)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks, 4 weeks

Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Treatment Continuous Passive Motion n=9 Participants Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
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)	-2.61 units on a scale Standard Deviation 1.51

Adverse Events

Treatment Continuous Passive Motion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniele Perl-Treves, Clinical Director

Radiancy Ltd

Phone: 972-97757556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place