Clinical trial NCT00414596: Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
Official title: Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.

Detailed description: Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided evidence in support of the FDA granted indications for use spinal decompression and of the DRX9000™. Axiom Worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of LBP to complete such a prospective evaluation using a standardized treatment protocol. This study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of LBP and sciatica.

Eligibility criteria: Inclusion Criteria:

* Male or female, greater than 18 years of age
* Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
* LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
* Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
* Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up

Exclusion Criteria:

* Pregnancy
* Evidence of neurological motor deficits on clinical examination
* Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
* Evidence of severe central stenosis with neurological deficits or nerve root entrapment
* Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
* Previous spine fusion surgery, insertion of hardware or artificial disc
* Hemiplegia or paraplegia
* History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
* Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
* Known alcohol abuse or drug abuse
* Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
* Body weight greater than 300 pounds (136 kg)

Primary outcomes:
measure: Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)
timeFrame: Six weeks
Secondary outcomes:
measure: Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.
timeFrame: Six weeks
measure: Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)
timeFrame: Six weeks
measure: Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.
timeFrame: Six weeks
measure: Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.
timeFrame: Six weeks
measure: Number of Patients Who Withdraw From Study.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Vibrance Medical Group
state: California
city: Naples
country: United States
facility: Naples Anesthesia and Pain Associates
state: Florida
city: Tampa
country: United States
facility: Active Health and Wellness Center
state: Florida
Study officials:
affiliation: Mayo Clinic
name: John Leslie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NEMA Research, Inc.
name: Charlotte Richmond, PhD
role: STUDY_DIRECTOR
affiliation: Naples Anesthesia and Pain Associates
name: Joseph V Pergolizzi, MD
role: STUDY_CHAIR
References: