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

This study has been completed.
Sponsor:
Information provided by:
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT00422045
First received: January 11, 2007
Last updated: December 15, 2010
Last verified: December 2010

January 11, 2007
December 15, 2010
December 2006
March 2010   (final data collection date for primary outcome measure)
  • FACES Pain Rating Scale [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • FACES Pain Rating Scale
  • Oswestry Low Back Pain Disability (ODQ) Questionnaire
  • Quality of Life – The Quality of Life Short-Form Survey (SF-36)
Complete list of historical versions of study NCT00422045 on ClinicalTrials.gov Archive Site
  • Pain medication usage [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Surgery
Device: Low Level Laser Therapy
Low Level Laser Therapy done after surgery.
  • No Intervention: 2
    No Laser done. All outcome measures are the same.
  • Experimental: 1
    Low Level Laser Therapy
    Intervention: Device: Low Level Laser Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422045
MUO-05
No
Ashok Biyani, MD, University of Toledo, Health Science Campus
University of Toledo Health Science Campus
Not Provided
Principal Investigator: Ashok Biyani, MD University of Toledo Health Science Campus
University of Toledo Health Science Campus
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP