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Rehabilitation Following Lumbar Disc Surgery

NCT ID: NCT00894972

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lumbar Disc Herniation Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise.

Group Type ACTIVE_COMPARATOR

Rehabilitation following lumbar disc surgery (discectomy)

Intervention Type OTHER

Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.

2

Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises.

Group Type EXPERIMENTAL

Rehabilitation following lumbar disc surgery (discectomy)

Intervention Type OTHER

Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.

Interventions

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Rehabilitation following lumbar disc surgery (discectomy)

Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Julie Fritz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Fritz, PT, PhD, ATC

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah, Department of Physical Therapy

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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32474

Identifier Type: -

Identifier Source: org_study_id