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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422045
First Posted: January 15, 2007
Last Update Posted: December 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Toledo Health Science Campus
  Purpose
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.

Condition Intervention
Surgery Device: Low Level Laser Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:
  • FACES Pain Rating Scale [ Time Frame: 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Pain medication usage [ Time Frame: 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 ]

Enrollment: 0
Study Start Date: December 2006
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422045


Locations
United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
Principal Investigator: Ashok Biyani, MD University of Toledo Health Science Campus
  More Information

Responsible Party: University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT00422045     History of Changes
Other Study ID Numbers: xMUO-05
First Submitted: January 11, 2007
First Posted: January 15, 2007
Last Update Posted: December 10, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms


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