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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT00422045
First received: January 11, 2007
Last updated: May 19, 2014
Last verified: May 2014
  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: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ashok Biyani, MD, University of Toledo, Health Science Campus
ClinicalTrials.gov Identifier: NCT00422045     History of Changes
Other Study ID Numbers: MUO-05
Study First Received: January 11, 2007
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014