Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
Primary Purpose
Surgery
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Level Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Surgery
Eligibility 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
Sites / Locations
- University of Toledo, Health Science Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
2
1
Arm Description
No Laser done. All outcome measures are the same.
Low Level Laser Therapy
Outcomes
Primary Outcome Measures
FACES Pain Rating Scale
Oswestry Low Back Pain Disability (ODQ) Questionnaire
Quality of Life - The Quality of Life Short-Form Survey (SF-36)
Secondary Outcome Measures
Pain medication usage
Improvement measured by serial photographs of surgery appearance and rate of healing
Full Information
NCT ID
NCT00422045
First Posted
January 11, 2007
Last Updated
December 9, 2014
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT00422045
Brief Title
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
Official Title
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
No Intervention
Arm Description
No Laser done. All outcome measures are the same.
Arm Title
1
Arm Type
Experimental
Arm Description
Low Level Laser Therapy
Intervention Type
Device
Intervention Name(s)
Low Level Laser Therapy
Intervention Description
Low Level Laser Therapy done after surgery.
Primary Outcome Measure Information:
Title
FACES Pain Rating Scale
Time Frame
baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Title
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
Title
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 Measure Information:
Title
Pain medication usage
Time Frame
baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Biyani, MD
Organizational Affiliation
University of Toledo Health Science Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo, Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
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Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
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