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Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Core Stabilization

Trunk Motion and Fitness

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, core stabilization, trunk muscle exercises, physical therapy, RCT

Eligibility Criteria

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

Inclusion Criteria:

duration of the current episode less than 3 months,
average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale,
self-report global function less than 80% (0-100 %, 100% = normal pain free function)
Oswestry Index > 19%
no physical therapy or chiropractic treatment for the current episode of low back pain.
clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding

Exclusion Criteria:

permanent structural spinal deformity (e.g., scoliosis),
spinal fracture or history of spinal fracture,
osteoporosis,
inflammatory joint disease,
signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
previous spinal surgery,
frank neurological loss, i.e., weakness and sensory loss in a NR distribution,
pain or paresthesia below the knee,
leg length discrepancy of greater than 2.5 cm,
history of neurologic disease that required hospitalization,
active treatment of another medical illness that would preclude participation in any aspect of the study,
pregnancy,
vestibular dysfunction,
extreme psychosocial involvement
allergies to medical tape or adhesives
Body mass index greater than 30 kg/m2

Sites / Locations

Drexel University Physical Therapy
Optimum Physical Therapy Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Core Stabilization

Trunk Motion and Fitness

Arm Description

8-week core stabilization program in 3 stage that emphasizes use of specific local trunk stabilizing muscles to restore active control and stability to the trunk. 8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions

8-week exercise program in 3 stages emphasizing spine motion, general trunk flexibility and strengthening and cardiovascular fitness. 8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions

Outcomes

Primary Outcome Measures

Trunk Neuromuscular Control

Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.

Secondary Outcome Measures

Clinical Outcomes

Oswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index

Full Information

NCT ID

NCT01360359

First Posted

May 24, 2011

Last Updated

March 9, 2015

Sponsor

Drexel University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT01360359

Brief Title

Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)

Official Title

Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Drexel University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. This study will provide preliminary evidence of the link between patient outcomes and treatment mechanisms. The investigators hypothesize that: both treatment groups will demonstrate significant improvements in pain and function; only subjects in the core stabilization group will demonstrate significant improvements in trunk movement and muscle control.

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, trunk muscle exercises, physical therapy, RCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Core Stabilization

Arm Type

Experimental

Arm Description

Arm Title

Trunk Motion and Fitness

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Core Stabilization

Intervention Description

3 Stages: Stage 1: emphasis on neutral spine position, co-contraction of stabilizing muscles with performance feedback through observation and palpation for correct muscle activation; patient education Stage 2: promotes maintenance of co-contraction while performing movements of the arms/legs and trunk progressing to preformance of these exercises on unstable surfaces; trunk muscle conditioning also emphasized; feedback gradually reduced. Stage 3: emphasis on maintenance of co-contraction while performing functional activities; stable and unstable surfaces; use of perturbation and random practice to enhance motor learning.

Intervention Type

Other

Intervention Name(s)

Trunk Motion and Fitness

Intervention Description

3 Stages: Stage 1: reducing pain and restoring spine motion and flexibility; patient education Stage 2: trunk muscle conditioning exercises Stage 3: trunk muscle conditioning and cardiovascular conditioning exercises

Primary Outcome Measure Information:

Title

Trunk Neuromuscular Control

Description

Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.

Time Frame

Baseline, 8 weeks

Secondary Outcome Measure Information:

Title

Clinical Outcomes

Description

Oswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index

Time Frame

Baseline, 8-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: duration of the current episode less than 3 months, average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale, self-report global function less than 80% (0-100 %, 100% = normal pain free function) Oswestry Index > 19% no physical therapy or chiropractic treatment for the current episode of low back pain. clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding Exclusion Criteria: permanent structural spinal deformity (e.g., scoliosis), spinal fracture or history of spinal fracture, osteoporosis, inflammatory joint disease, signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection), previous spinal surgery, frank neurological loss, i.e., weakness and sensory loss in a NR distribution, pain or paresthesia below the knee, leg length discrepancy of greater than 2.5 cm, history of neurologic disease that required hospitalization, active treatment of another medical illness that would preclude participation in any aspect of the study, pregnancy, vestibular dysfunction, extreme psychosocial involvement allergies to medical tape or adhesives Body mass index greater than 30 kg/m2

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 Physical Therapy

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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Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)

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