NCT00426166

Brief Summary

The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
13.4 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

January 22, 2007

Results QC Date

November 11, 2014

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • FACES Pain Rating Scale Scores

    The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

    baseline (2 weeks after surgery)

  • FACES Pain Rating Scale Scores

    The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

    6 weeks after surgery

  • FACES Pain Rating Scale.

    The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

    12 weeks after surgery

Secondary Outcomes (15)

  • 36-Item Short Form Survey - Bodily Pain Scores

    baseline (2 weeks after surgery)

  • 36-Item Short Form Survey - Bodily Pain Scores

    6 weeks after surgery

  • 36-Item Short Form Survey - Bodily Pain Scale

    12 weeks after surgery

  • 36-Item Short Form Survey - General Health

    2 weeks after surgery (baseline)

  • 36-Item Short Form Survey - General Health

    6 weeks after surgery

  • +10 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Low Level Laser Therapy

Device: Low Level Laser Therapy

2

NO INTERVENTION

No Laser Therapy. Outcome Measures the same.

Interventions

7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.

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
  • Acute traumatic injury of an upper extremity (wrist, forearm, or elbow)
  • 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
  • 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

Results Point of Contact

Title
Dr. Martin Skie
Organization
University of Toledo

Study Officials

  • Martin Skie, MD

    University of Toledo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 24, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2009

Study Completion

May 1, 2011

Last Updated

April 23, 2025

Results First Posted

September 19, 2024

Record last verified: 2025-04

Locations