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Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery

NCT ID: NCT00422045

Last Updated: 2014-12-10

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-12-31

Brief Summary

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The primary objective of this study is to assess whether or not low level laser therapy (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.

Detailed Description

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Lumbar fusion surgery patients typically experience significant post-operative pain for several weeks and their rehabilitation does not start until 8 - 12 weeks postoperatively. We hypothesize that LLLT beginning 4 weeks postoperatively will provide significant reduction in postoperative pain.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

No Laser done. All outcome measures are the same.

Group Type NO_INTERVENTION

No interventions assigned to this group

1

Low Level Laser Therapy

Group Type EXPERIMENTAL

Low Level Laser Therapy

Intervention Type DEVICE

Low Level Laser Therapy done after surgery.

Interventions

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Low Level Laser Therapy

Low Level Laser Therapy done after surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 and \< 85 years
* Post-operative lumbar fusion surgery
* Currently resides within 100 miles of UMC

Exclusion Criteria

* Pregnant
* Pacemaker
* Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)
* Two or more cardiac risk factors
* Intraoperative complications
* Wound infection
* Spinal fluid leakage
* Open wound
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashok Biyani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toledo Health Science Campus

Locations

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University of Toledo, Health Science Campus

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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xMUO-05

Identifier Type: -

Identifier Source: org_study_id