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Clinical Prediction Rule for Clinical Lumbar Instability

Primary Purpose

Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core Stabilization
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain focused on measuring low back pain, core stabilization, physical therapy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. duration of the current episode of low back pain less than 3 months,
  2. 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,
  3. no medical intervention for low back pain in last 6 months,
  4. Oswestry score greater than 25%

Exclusion Criteria:

  1. permanent structural spinal deformity (e.g., scoliosis)
  2. history of spinal fracture or diagnosis of osteoporosis
  3. diagnosis of inflammatory joint disease
  4. signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
  5. previous spinal surgery
  6. frank neurological loss, i.e., weakness and sensory loss
  7. history of neurologic disease that required hospitalization,
  8. 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
  9. leg length discrepancy of greater than 2.5 cm.
  10. pregnancy
  11. vestibular dysfunction

Sites / Locations

  • Drexel University
  • Optimum Physical Therapy Associates

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Low back pain

Arm Description

Individuals with current low back pain.

Outcomes

Primary Outcome Measures

Oswestry Disability Index
measure of functional limitation

Secondary Outcome Measures

Numeric Pain Scale
measure of preceived pain

Full Information

First Posted
March 10, 2010
Last Updated
November 4, 2013
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT01085448
Brief Title
Clinical Prediction Rule for Clinical Lumbar Instability
Official Title
Identifying the Subgroup of Patient With Mechanical Low Back Pain Who Have Clinical Lumbar Instability
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
lack of timely recruitment of subjects
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Clinical identification of individuals with mechanical low back pain who would benefit from a program of stabilization exercises has been a struggle for the physical therapy profession. While changes in trunk muscle recruitment and motor control have been linked to patients with chronic low back pain and hypothesized to be adaptations for spinal instability, this has not been systematically established. However, a connection between spinal instability, poor trunk motor control, and low back pain is plausible. The real problem lies with the clinical identification of the subgroup of patients in either the acute or chronic phases of low back dysfunction who would most benefit from this approach to intervention. In creating their preliminary clinical prediction rule, Hicks et al (2005), looked at many variables including patient demographics and characteristics, hip and trunk motion, special tests for instability, and functional measures of muscle performance. However, measures of the performance of core stabilizing muscles and assessment of trunk dynamic control/ coordination were not included as potential variables. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, core stabilization, physical therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low back pain
Arm Type
Other
Arm Description
Individuals with current low back pain.
Intervention Type
Other
Intervention Name(s)
Core Stabilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
measure of functional limitation
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Scale
Description
measure of preceived pain
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheri P. Silfies, PT, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Optimum Physical Therapy Associates
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States

12. IPD Sharing Statement

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Clinical Prediction Rule for Clinical Lumbar Instability

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