Rehabilitation Following Lumbar Disc Surgery
Primary Purpose
Lumbar Disc Herniation, Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rehabilitation following lumbar disc surgery (discectomy)
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
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)
Sites / Locations
- University of Utah, Department of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise.
Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises.
Outcomes
Primary Outcome Measures
Modified Oswestry disability index
Secondary Outcome Measures
Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00894972
Brief Title
Rehabilitation Following Lumbar Disc Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise.
Arm Title
2
Arm Type
Experimental
Arm Description
Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises.
Intervention Type
Other
Intervention Name(s)
Rehabilitation following lumbar disc surgery (discectomy)
Intervention Description
Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
Primary Outcome Measure Information:
Title
Modified Oswestry disability index
Time Frame
Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
Secondary Outcome Measure Information:
Title
Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging
Time Frame
preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Fritz, PT, PhD, ATC
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah, Department of Physical Therapy
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation Following Lumbar Disc Surgery
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