Clinical Prediction Rule for Clinical Lumbar Instability

NCT01085448 | Terminated

• 1 other identifier: DRX18590
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises. Question: What clinical characteristics are associated with patients that respond positively to a program of core stabilization exercises? Hypothesis: Clinical characteristics that show a decrease in trunk motor control will be associated with a positive response to stabilization exercises.

Conditions

Low Back Pain

Keywords

low back pain; core stabilization; physical therapy

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  measure of functional limitation

  Baseline, 8 weeks

Secondary Outcomes (1)

• Numeric Pain Scale

  Baseline, 8 weeks

Study Arms (1)

Low back pain

OTHER

Individuals with current low back pain.

Other: Core Stabilization

Interventions

Core Stabilization OTHER

The 8-week program emphasizes use of specific local stabilizing muscles (transverse abdominis\[TrA\], lumbar multifidus\[LM\]) to restore active control to the trunk. Emphasis is on training isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm. Stage 1: neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation. Stage 2: maintenance the co-contraction while performing movements of the trunk and the upper and lower extremities. Trunk conditioning is also emphasized. Feedback is gradually reduced. Stage 3: maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning.

Low back pain

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• duration of the current episode of low back pain less than 3 months,
• average pain intensity over past 3 days at least 4 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
• no medical intervention for low back pain in last 6 months,
• Oswestry score greater than 25%

You may not qualify if:

• permanent structural spinal deformity (e.g., scoliosis)
• history of spinal fracture or diagnosis of osteoporosis
• diagnosis of inflammatory joint disease
• signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
• previous spinal surgery
• frank neurological loss, i.e., weakness and sensory loss
• history of neurologic disease that required hospitalization,
• active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing
• leg length discrepancy of greater than 2.5 cm.
• pregnancy
• vestibular dysfunction

Sponsors & Collaborators

• Drexel University: lead

Study Sites (2)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Optimum Physical Therapy Associates

West Chester, Pennsylvania, 19380, 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

• Sheri P. Silfies, PT, PhD

  Drexel University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

US (2)