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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360359
• Other study ID #: K01HD053632
• Secondary ID: K01HD053632
• Status: Completed
• Phase: N/A
• First received: May 24, 2011
• Last updated: March 9, 2015
• Start date: May 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
United States	Drexel University Physical Therapy	Philadelphia	Pennsylvania
United States	Optimum Physical Therapy Associates	West Chester	Pennsylvania

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk Neuromuscular Control	Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.	Baseline, 8 weeks	No
Secondary	Clinical Outcomes	Oswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index	Baseline, 8-weeks	No