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Completed

NCT Number: NCT01360359

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University Physical Therapy, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Core Stabilization

Other

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.

Trunk Motion and Fitness

Other

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 outcomes

  1. Trunk Neuromuscular Control

    Time frame: Baseline, 8 weeks

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

Secondary outcomes

  1. Clinical Outcomes

    Time frame: Baseline, 8-weeks

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

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 25, 2011
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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