Clinical trial NCT01360359: Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)
Official title: Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
core stabilization
trunk muscle exercises
physical therapy
RCT
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-05-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Trunk Neuromuscular Control
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: Baseline, 8-weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Physical Therapy
state: Pennsylvania
city: West Chester
country: United States
facility: Optimum Physical Therapy Associates
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Sheri P. Silfies, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: