Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729181
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Integrity Life Sciences

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Low Back Pain Device: DRX9000

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality: A Retrospective Study
Study Start Date : February 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. [ Time Frame: 12-16 weeks ]
    0= no pain; 10=worst pain


Secondary Outcome Measures :
  1. Functional capacity, measured by activities of daily living [ Time Frame: 12-16 weeks ]
  2. Proportion of patients using adjuvant analgesic medication [ Time Frame: 12-16 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pain Management Clinic
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Integrity Life Sciences
ClinicalTrials.gov Identifier: NCT02729181    
Other Study ID Numbers: Axiom-CA-L1N-8R1
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations