Rehabilitation Following Lumbar Disc Surgery

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894972
• Other study ID #: 32474
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: November 5, 2012
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: November 2012
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah, Department of Physical Therapy	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Oswestry disability index		Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months	No
Secondary	Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging		preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months	No