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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422045

Enrollment

Registered

2007-01-15

Start date

2006-12-31

Completion date

2010-12-31

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Interventions

DEVICELow Level Laser Therapy

Low Level Laser Therapy done after surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026