NCT00422045

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

3.2 years

First QC Date

January 11, 2007

Last Update Submit

December 9, 2014

Conditions

Surgery

Outcome Measures

Primary Outcomes (3)

  • FACES Pain Rating Scale

    baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline

  • Oswestry Low Back Pain Disability (ODQ) Questionnaire

    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)

    baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter

Secondary Outcomes (2)

  • Pain medication usage

    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

    2 weeks after surgery, then 6, 12, and 24 weeks after surgery

Study Arms (2)

2

NO INTERVENTION

No Laser done. All outcome measures are the same.

1

EXPERIMENTAL

Low Level Laser Therapy

Device: Low Level Laser Therapy

Interventions

Low Level Laser TherapyDEVICE

Low Level Laser Therapy done after surgery.

1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 and \< 85 years
  • Post-operative lumbar fusion surgery
  • Currently resides within 100 miles of UMC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Ashok Biyani, MD

    University of Toledo Health Science Campus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

December 1, 2006

Primary Completion

March 1, 2010

Study Completion

December 1, 2010

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(1)