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

NCT01360359 | Completed

• 1 other identifier: K01HD053632
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical Outcomes

  Baseline, 8-weeks

Study Arms (2)

Core Stabilization

EXPERIMENTAL

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

Other: Core Stabilization

Trunk Motion and Fitness

ACTIVE COMPARATOR

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

Other: Trunk Motion and Fitness

Interventions

Core Stabilization 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.

Core Stabilization

Trunk Motion and Fitness 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

Trunk Motion and Fitness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• duration of the current episode less than 3 months,
• 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,
• self-report global function less than 80% (0-100 %, 100% = normal pain free function)
• Oswestry Index \> 19%
• no physical therapy or chiropractic treatment for the current episode of low back pain.
• clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding

You may not qualify if:

• permanent structural spinal deformity (e.g., scoliosis),
• spinal fracture or history of spinal fracture,
• osteoporosis,
• inflammatory joint disease,
• signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
• previous spinal surgery,
• frank neurological loss, i.e., weakness and sensory loss in a NR distribution,
• pain or paresthesia below the knee,
• leg length discrepancy of greater than 2.5 cm,
• history of neurologic disease that required hospitalization,
• active treatment of another medical illness that would preclude participation in any aspect of the study,
• pregnancy,
• vestibular dysfunction,
• extreme psychosocial involvement
• allergies to medical tape or adhesives

Sponsors & Collaborators

• Drexel University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Drexel University Physical Therapy

Philadelphia, Pennsylvania, 19102, United States

Location

Optimum Physical Therapy Associates

West Chester, Pennsylvania, 19380, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheri P. Silfies, PT, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (2)