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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729181
• Other study ID #: Axiom-CA-L1N-8R1
• Status: Completed
• Phase: N/A
• First received: March 22, 2016
• Last updated: April 5, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Integrity Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: FSI Scientific Center of Expertise of Medical Application
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• DRX9000

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Integrity Life Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Functional capacity, measured by activities of daily living		12-16 weeks	No
Secondary	Proportion of patients using adjuvant analgesic medication		12-16 weeks	No