Rehabilitation Following Lumbar Disc Surgery

Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial

The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). Both groups will begin treatment 2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation; Radiculopathy
• Intervention / Treatment: Other: Rehabilitation following lumbar disc surgery (discectomy)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah, Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-60 years old
• Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
• Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
• Able to attend weekly treatment sessions.

Exclusion Criteria:

• Prior surgery to the lumbar spine
• Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
• Unable to speak and understand English
• Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
• Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise.	Other: Rehabilitation following lumbar disc surgery (discectomy); Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
Experimental: 2; Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises.	Other: Rehabilitation following lumbar disc surgery (discectomy); Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified Oswestry disability index	Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months

Secondary Outcome Measures

Outcome Measure	Time Frame
Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging	preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Julie Fritz, PT, PhD, ATC, University of Utah

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 6, 2009
• First Posted (Estimate): May 7, 2009

Study Record Updates

• Last Update Posted (Estimate): November 6, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: 32474