Recurrent Low Back Pain:Linking Mechanisms to Outcomes

NCT01085604 | Completed

• 2 other identifiers: K01HD053632TK01HD053632
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization. Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control strategies. Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be tested using a known group method demonstrating:

• no significant change in motor control measures within the untreated, healthy control group.
• significant changes within the low back subjects who demonstrate clinically meaningful improvements.

Conditions

Low Back Pain

Keywords

low back pain; clinical instability; neuromuscular control; core stabilization; physical therapy

Outcome Measures

Primary Outcomes (1)

• Trunk Neuromuscular Control

  Using surface EMG, trunk kinematics and force plate parameters. Trunk motor control is characterized and compared between groups and pre/post intervention in the low back pain group.

  Baseline, 8 weeks

Secondary Outcomes (1)

• Oswestry Disability Index

  Baseline, 8 weeks

Study Arms (1)

Low back pain

Individuals with current low back pain attributed to poor trunk neuromuscular control (clinical instability).

Other: Core Stabilization

Interventions

Core Stabilization OTHER

The 8-week core stabilization program emphasizes use of specific local stabilizing muscles (transverse abdominis\[TrA\], lumbar multifidus\[LM\]) to restore active control and stability to the trunk. This program emphasizes training using isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm. Stage 1: emphasizes neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation. Stage 2: promotes maintenance the co-contraction while performing movements of the trunk and superimposing movements of the upper and lower extremities. Trunk conditioning is also emphasized (i.e., curl ups, quadruped leg/arm lifts and side support). Feedback is gradually reduced. Stage 3: emphasis on 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: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic physical therapy clinic community

You may qualify if:

• No history of low back is defined as:
• no pain limiting performance of daily activities for greater than 3 days,
• no pain for which they sought medical or allied health intervention.
• duration of the current episode of low back pain less than 3 months,
• average pain intensity over past 2 weeks at least 3 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 disability score greater than 20%
• a physical therapy diagnosis of clinical lumbar instability based upon specific examination findings.

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

Study Sites (2)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Optimum Physical Therapy Associates

West Chester, Pennsylvania, 19380, United States

Location

Related Publications (2)

• Sung W, Abraham M, Plastaras C, Silfies SP. Trunk motor control deficits in acute and subacute low back pain are not associated with pain or fear of movement. Spine J. 2015 Aug 1;15(8):1772-82. doi: 10.1016/j.spinee.2015.04.010. Epub 2015 Apr 8.

  PMID: 25862508 RESULT

• Mehta R, Cannella M, Henry SM, Smith S, Giszter S, Silfies SP. Trunk Postural Muscle Timing Is Not Compromised In Low Back Pain Patients Clinically Diagnosed With Movement Coordination Impairments. Motor Control. 2017 Apr;21(2):133-157. doi: 10.1123/mc.2015-0049. Epub 2016 Aug 19.

  PMID: 26623551 RESULT

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: August 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

US (2)