Manual Unloading of the Lumbar Spine: Can it Predict Responders to Mechanical Traction?

NCT02026076 | Completed

• 1 other identifier: Manual Unloading
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will seek to determine if 1) the manual unloading test is reliable, and 2)if the immediate response to traction can be determined by using a simple unloading test in standing. The study wil be completed in two parts: 1) a small pilot sample (n=10) to asses both intra and inter tester reliability, and 2) a consecutive sample of 30 patients with low back pain which does not travel below the knee. All subjects will rate their pain on a 100 mm line both at rest and in their most painful direction of movement. A therapist will then unload the patients spine to determine if they feel any relief. All subjects will then undergo a 15 minute bout of intermittent lumbar traction, 30 sec on, 10 sec off at up to 50% body weight. Following traction, all subjects will again rate their pain on a 100 mm line. Subjects will be grouped by response to the initial manual unloading test and assessed for within and between group differences. The study hypothesis is that the manual unloading test is reliable, and that responders to mechanical traction can be accurately identified using a manual unloading test.

Conditions

Low Back Pain

Keywords

low back pain; traction; unloading

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog pain scale in the most provocative movement

  immediate post intervention (within 5 minutes following intervention)

Study Arms (1)

manual unloading

EXPERIMENTAL

All subjects will first undergo a manual unloading test, followed by a single application of mechanical lumbar traction to determine predictive effect

Other: mechanical lumbar traction

Interventions

mechanical lumbar traction OTHER

15 minutes at up to 50% body weight lumbar traction in supine hooklying with split table open

manual unloading

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18-75
• non-radicular low back pain (LBP)

You may not qualify if:

• tumor,
• fracture,
• infectious disorder,
• central nervous system involvement,
• presence of medical red flags,
• absence of LBP,
• radicular leg pain (below the knee),
• pregnancy,
• epidural steroid injection within 4 weeks prior to study involvement,
• previous back surgery,
• workers compensation involvement
• active litigation

Sponsors & Collaborators

• UConn Health: lead
• Andrews University: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isaac Moss, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: January 1, 2014
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 1, 2014

Record last verified: 2013-11

Locations

US (1)