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

NCT ID: NCT01360359

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-03-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Core Stabilization

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Trunk Motion and Fitness

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Sheri Silfies

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheri P. Silfies, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University Physical Therapy

Philadelphia, Pennsylvania, United States

Optimum Physical Therapy Associates

West Chester, Pennsylvania, United States

Countries

United States

Other Identifiers

K01HD053632

Identifier Type: NIH

Identifier Source: secondary_id

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K01HD053632

Identifier Type: NIH

Identifier Source: org_study_id

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