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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01360359
Enrollment
17
Registered
2011-05-25
Start date
2011-05-31
Completion date
2015-03-31
Last updated
2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, core stabilization, trunk muscle exercises, physical therapy, RCT

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.

Interventions

OTHERCore 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.

OTHERTrunk 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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Trunk Neuromuscular ControlBaseline, 8 weeksUsing surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.

Secondary

MeasureTime frameDescription
Clinical OutcomesBaseline, 8-weeksOswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026