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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Drexel University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sheri Silfies, Drexel University
ClinicalTrials.gov Identifier:
NCT01360359
First received: May 24, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Low Back Pain
Other: Core Stabilization
Other: Trunk Motion and Fitness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Trunk Neuromuscular Control [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 8-weeks ] [ Designated as safety issue: No ]
    Oswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Core Stabilization

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

Other: Core Stabilization

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.

Active Comparator: Trunk Motion and Fitness

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

Other: Trunk Motion and Fitness

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


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. duration of the current episode less than 3 months,
  2. 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,
  3. self-report global function less than 80% (0-100 %, 100% = normal pain free function)
  4. Oswestry Index > 19%
  5. no physical therapy or chiropractic treatment for the current episode of low back pain.
  6. clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding

Exclusion Criteria:

  1. permanent structural spinal deformity (e.g., scoliosis),
  2. spinal fracture or history of spinal fracture,
  3. osteoporosis,
  4. inflammatory joint disease,
  5. signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
  6. previous spinal surgery,
  7. frank neurological loss, i.e., weakness and sensory loss in a NR distribution,
  8. pain or paresthesia below the knee,
  9. leg length discrepancy of greater than 2.5 cm,
  10. history of neurologic disease that required hospitalization,
  11. active treatment of another medical illness that would preclude participation in any aspect of the study,
  12. pregnancy,
  13. vestibular dysfunction,
  14. extreme psychosocial involvement
  15. allergies to medical tape or adhesives
  16. Body mass index greater than 30 kg/m2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360359

Locations
United States, Pennsylvania
Drexel University Physical Therapy Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Sheri P. Silfies, PT, PhD    215-762-3589    silfies@drexel.edu   
Contact: Won Sung, DPT    215-762-3589    wss26@drexel.edu   
Principal Investigator: Sheri P. Silfies, PT, PhD         
Optimum Physical Therapy Associates Recruiting
West Chester, Pennsylvania, United States, 19380
Contact: Scott A. Biely, PT, DPT    610-349-6997    sbiely@aol.com   
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Sheri P. Silfies, PT, PhD Drexel University
  More Information

No publications provided

Responsible Party: Sheri Silfies, Principal Investigator, Drexel University
ClinicalTrials.gov Identifier: NCT01360359     History of Changes
Other Study ID Numbers: K01-HD053632, K01HD053632
Study First Received: May 24, 2011
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
low back pain
core stabilization
trunk muscle exercises
physical therapy
RCT

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014