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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00422045
• Other study ID #: xMUO-05
• Status: Withdrawn
• Phase: N/A
• First received: January 11, 2007
• Last updated: December 9, 2014
• Start date: December 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery

Intervention

Device:
• Low Level Laser Therapy
Low Level Laser Therapy done after surgery.

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACES Pain Rating Scale		baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline	No
Primary	Oswestry Low Back Pain Disability (ODQ) Questionnaire		baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter	No
Primary	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	No
Secondary	Pain medication usage		baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline	No
Secondary	Improvement measured by serial photographs of surgery appearance and rate of healing		2 weeks after surgery, then 6, 12, and 24 weeks after surgery	No