Assessment of Activities of Daily Living in Adults With C... | NCT02729181

Studies
Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality

NCT02729181

Sponsor

Integrity Life Sciences

Status

Completed

Last Update Posted

Apr 6, 2016Estimated

Enrollment

116Actual

Phase

Not provided

Conditions

Low Back Pain

Interventions

DRX9000

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Nov 2015Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 22, 2016

First Submission Date that Met QC Criteria

Apr 5, 2016

First Posted Date

Apr 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2016

Last Update Posted Date

Apr 6, 2016Estimated

Description Module

Brief Summary

The investigators hypothesize that treatment with non-invasive spinal decompression reduces discogenic low back pain (LBP), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Name	Type	Description	Arm Group Labels	Other Names
DRX9000	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lower back pain measured on an 11-point numeric rating scale (VAS) with 0 reflecting no pain at all and 10 the worst imaginable pain.	0= no pain; 10=worst pain	12-16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Functional capacity, measured by activities of daily living		12-16 weeks
Proportion of patients using adjuvant analgesic medication		12-16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 18 years of age;
consented to the physician prescribed protocol;
presented with discogenic low back pain defined as low back pain for minimum of 12 weeks;
current CT scan

Exclusion Criteria:

metastatic cancer;
previous spinal fusion or placement of stabilization hardware within 6 months;
instrumentation or artificial discs;
neurologic motor deficits, bladder, or sexual dysfunction;
alcohol or drug abuse
patient's with extremes of height (< 147 cm or > 203 cm) and body weight (> 136 kg).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Pain Management Clinic

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided