Trial Outcomes & Findings for Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System (NCT NCT00414596)

Results Overview

The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Six weeks

Results posted on

2016-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	DRX Group Patients using the device DRX9000™.
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DRX Group Patients using the device DRX9000™.
Overall Study Protocol Violation	2

Baseline Characteristics

Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DRX Group n=20 Participants Patients using the device DRX9000™.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46.6 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Six weeks

The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.

Outcome measures

Outcome measures
Measure	DRX Group n=18 Participants Patients using the device DRX9000™.
Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)	0 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Six weeks

The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded.

Outcome measures

Outcome measures
Measure	DRX Group n=18 Participants Patients using the device DRX9000™.
Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.	1 participants

SECONDARY outcome

Timeframe: Six weeks

Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks.

Outcome measures

Outcome measures
Measure	DRX Group n=18 Participants Patients using the device DRX9000™.
Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) Baseline	26 Change in units of scale Interval 7.0 to 34.0
Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) Week 3	14 Change in units of scale Interval 0.0 to 26.0
Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) Week 6	3 Change in units of scale Interval 0.0 to 26.0

SECONDARY outcome

Timeframe: Six weeks

Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied).

Outcome measures

Outcome measures
Measure	DRX Group n=18 Participants Patients using the device DRX9000™.
Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.	8.1 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Six weeks

Population: All subjects enrolled were included in the analysis. No adverse events related to study device were reported.

Total number of adverse events reported following 6 weeks of DRX9000 treatment.

Outcome measures

Outcome measures
Measure	DRX Group n=20 Participants Patients using the device DRX9000™.
Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.	10 Number of Adverse Events

SECONDARY outcome

Timeframe: 6 weeks

Total number of patients who withdrew during the 6 weeks of treatment.

Outcome measures

Outcome measures
Measure	DRX Group n=20 Participants Patients using the device DRX9000™.
Number of Patients Who Withdraw From Study.	2 participants

Adverse Events

DRX Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DRX Group n=20 participants at risk Patients using the device DRX9000™.
Musculoskeletal and connective tissue disorders Neck Pain	5.0% 1/20 • Number of events 1
General disorders Head Colds	10.0% 2/20 • Number of events 2
General disorders Sinus Headaches	10.0% 2/20 • Number of events 2
Infections and infestations Sinus Infection	5.0% 1/20 • Number of events 1
Musculoskeletal and connective tissue disorders Shoulder Pain	5.0% 1/20 • Number of events 1
Infections and infestations Influenza	5.0% 1/20 • Number of events 1
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Number of events 1
Endocrine disorders Adrenal Insufficiency	5.0% 1/20 • Number of events 1

Additional Information

Jospeph V Pergolizzi, MD

NEMA Research, Inc

Phone: 239-597-3564

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place