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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Withdrawn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

About this trial

This is an interventional treatment trial for Surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Withdrawn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

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

Arm Type

No Intervention

Arm Description

No Laser done. All outcome measures are the same.

Arm Title

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

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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