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

December 9, 2014 updated by: University of Toledo Health Science Campus
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo, Health Science Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
No Laser done. All outcome measures are the same.
Experimental: 1
Low Level Laser Therapy
Device: Low Level Laser Therapy
Low Level Laser Therapy done after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FACES Pain Rating Scale
Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Oswestry Low Back Pain Disability (ODQ) Questionnaire
Time Frame: baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
Quality of Life - The Quality of Life Short-Form Survey (SF-36)
Time Frame: baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain medication usage
Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Improvement measured by serial photographs of surgery appearance and rate of healing
Time Frame: 2 weeks after surgery, then 6, 12, and 24 weeks after surgery
2 weeks after surgery, then 6, 12, and 24 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toledo Health Science Campus

Investigators

  • Principal Investigator: Ashok Biyani, MD, University of Toledo Health Science Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 15, 2007

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xMUO-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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