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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
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 5, 2009
Last Updated
November 5, 2012
Sponsor
University of Utah
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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

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Rehabilitation Following Lumbar Disc Surgery

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