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

Drexel University

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Core Stabilization; Other: Trunk Motion and Fitness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01360359

K01HD053632 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Core Stabilization

Experimental group

Description:

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

Treatment:

Other: Core Stabilization

Trunk Motion and Fitness

Active Comparator group

Description:

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

Treatment:

Other: Trunk Motion and Fitness