SurgeryNCT00422045
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
A study testing Low Level Laser Therapy in people with Surgery, run by University of Toledo Health Science Campus at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Surgery
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 85 years
- Post-operative lumbar fusion surgery
- Currently resides within 100 miles of UMC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Low Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Low Level Laser Therapy done after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | No Laser done. All outcome measures are the same. |
| 1 | Experimental | Low Level Laser Therapy Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACES Pain Rating Scale
Measured: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Oswestry Low Back Pain Disability (ODQ) Questionnaire
Measured: 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)
Measured: baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
Secondary outcomes (2)
Pain medication usage
Measured: 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
Measured: 2 weeks after surgery, then 6, 12, and 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashok Biyani, MD, Principal investigator, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422045
- Sponsor's protocol ID
- xMUO-05
- Status last verified
- Dec 2014
- First submitted
- 11 Jan 2007
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT00422045
- Acronym / sponsor ID
- xMUO-05
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –No Laser done. All outcome measures are the same. |
| 1 | Experimental | Device: Low Level Laser TherapyLow Level Laser Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 and < 85 years
- Post-operative lumbar fusion surgery
- Currently resides within 100 miles of UMC
Key exclusion criteria (8 listed)
- Pregnant
- Pacemaker
- Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)
- Two or more cardiac risk factors
- Intraoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyLow Level Laser Therapy done after surgery. | Device | 1 |
Primary outcome
FACES Pain Rating Scale
Time frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
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
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
2 secondary outcomes
Pain medication usage
Time frame: 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
Time frame: 2 weeks after surgery, then 6, 12, and 24 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Biyani, MD principal investigator
University of Toledo Health Science Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Surgery, run by University of Toledo Health Science Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACES Pain Rating Scale (time frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.