Recurrent Low Back Pain:Linking Mechanisms to Outcomes

Low Back Pain Clinical Trial

Official title:

Recurrent Low Back Pain:Linking Mechanisms to Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085604
• Other study ID #: K01HD053632T
• Secondary ID: K01HD053632
• Status: Completed
• Start date: August 2009
• Est. completion date: June 2015

Study information

• Verified date: July 2018
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region is an important finding in a large number of patients with recurrent and chronic low back pain and may play a role in recurrence of symptoms. Despite findings of altered trunk motor control in individuals with low back pain, the neuromuscular strategies underlying these alterations have not been satisfactorily characterized. The aims of this study are to(1) identify which neural control strategies are altered following a rehabilitation program that emphasizes trunk control and stability using a motor learning approach and (2) provide preliminary evidence of a link between hypothesized mechanism and effectiveness for programs designed to improve trunk control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria for healthy controls:

No history of low back is defined as:

1. no pain limiting performance of daily activities for greater than 3 days,

2. no pain for which they sought medical or allied health intervention.

Inclusion Criteria for individuals with a history of low back pain:

1. duration of the current episode of low back pain less than 3 months,

2. 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,

3. no medical intervention for low back pain in last 6 months,

4. Oswestry disability score greater than 20%

5. a physical therapy diagnosis of clinical lumbar instability based upon specific examination findings.

Exclusion Criteria for both groups:

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Core Stabilization
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.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania
United States	Optimum Physical Therapy Associates	West Chester	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.20 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oswestry Disability Index	measure of functional limitations	Baseline, 8 weeks