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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Core Stabilization; Other: Trunk Motion and Fitness

• Registration Number: NCT01360359
• Lead Sponsor: Drexel University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Core Stabilization	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
Trunk Motion and Fitness	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

Primary Outcome Measures

Name	Time	Method
Trunk Neuromuscular Control	Baseline, 8 weeks	Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes	Baseline, 8-weeks	Oswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index

Trial Locations

Locations (2)

Drexel University Physical Therapy; 🇺🇸 Philadelphia, Pennsylvania, United States

Optimum Physical Therapy Associates; 🇺🇸 West Chester, Pennsylvania, United States