Failed Back Surgery SyndromeLASPINENCT02529657
Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery
A study testing Low Level Laser Therapy in people with Failed Back Surgery Syndrome, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Each year, more than one million individuals worldwide are submitted to laminectomies, with a failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause of ''failed back surgery syndrome'' and associated with increased risk of complications during revision surgery. Read more about this study
- Who is it for?
- Ages 10 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Jun 2018
- 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 10 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing to lumbar laminectomy
Who cannot join
- Active lumbar cancer
- Infectious disease
- Coagulation disorders
- Dural injury during the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Effect of Low Level Laser Therapy in Spinal Surgery
Each year, more than one million individuals worldwide are submitted to laminectomies, with a failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause of ''failed back surgery syndrome'' and associated with increased risk of complications during revision surgery. The postoperative epidural scar can cause extradural compression or dural tethering, which results in recurrent radicular pain and physical impairment. Several studies in the literature are signalizing that Low-Level-Laser-Therapy (LLLT) is proven to be an effective tool to assist the inflammatory process and wound healing, as well to prevent infection. Thus, the objectives of this project are to delineate and evaluate the LLLT effects in spinal surgery. A prospective randomized, controlled trial with a total of 48 patients who underwent laminectomy, were divided into 2 groups. In the first group, 25 patients received LLLT during the surgical procedure over dura mater, over subcutaneous and on the skin, as well as 24h and 72h post surgery. In the second group, 23 patients were induced to think they will be getting the same treatment, although the laser is not operating. In those groups, C reactive protein, Lactate Dehydrogenase and Creatine kinase were evaluated in the second and fifth days after surgery, digital temperature will be measured and scores in visual analogue scale will be used, 5 minutes pre and 5 minutes post Laser application. The drainage output was collected in the first three days following surgery in both groups. Interleukins were evaluated in interstitial infiltrate drained in 24h and 48h. The data was evaluated for normality and subjected to appropriate statistical analysis, in order to seek representation, as same as the level of significance of the studied samples.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Low Level Laser Therapy, Placebo
- Keywords
- Lower Level Laser Therapy (LLLT), inflammation, cytokines, wound healing, laminectomy, clinical study
- Medical subject headings
- Failed Back Surgery Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyRadiation
In 23 randomized patients, LLLT (B-Cure, Good Energies ®, Israel), with CW diode laser - semiconductor Gallium Arsenide and aluminum (GaAlAs) will be applied during surgery (λ = 804 nm ± 2 , total exposure time of 240 s, energy density of 2.48 J/cm2 , average power of 40 mW , spot area of 3,876 cm2), in contact mode, for 60 seconds on the laminectomy site, 60 seconds and 120 seconds in the subcutaneous tissue of the skin over the wound bed, respectively. In the first and second day post surgery, will be collected the drainage output for analysis of interleukin 1, 4, 6, 8 and 10 (IL- 1, IL-4, IL -6, IL-8 and IL -10 ) and tumor necrosis factor alpha ( TNF -alpha ).
PlaceboProcedure or surgery
In the operating room, lumbar laminectomy will be performed in 46 patients. During the surgery, 24 hours and 48 hours after surgery, the patients received the regular treatment after laminectomy and were induced to thing that were receiving low level laser therapy in their wound.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating. Receives: Procedure: Placebo |
| Low level Laser Therapy | Experimental | 25 patients were submitted to spine surgery and have received low level laser therapy during surgery, 24 hours after surgery and 48 hours after surgery. Receives: Radiation: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours
Interstitial infiltrate obtained of Lumbar Drain collected 24 hours after surgery, interleukins IL-1, IL-4, IL-8, IL-10 and TNF alfa were measured through Immunochemistry, using ELISA.
Measured: 24 hours after surgery
Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery
Interstitial infiltrate was obtained of Lumbar Drain collected 48 hours after surgery, in this infiltrate interleukins IL-1, IL-4, IL-8, IL10 and TNF alfa were measured through Immunochemistry, using ELISA.
Measured: 48h after surgery
Secondary outcomes (2)
Score in Visual Analogue Scale
Patient had to choose between 0 and 10 on the 11 point short pain scale.
Measured: 5 minutes pre LLLT
Score in Visual Analogue Scale
Change from baseline in pain on the 11 point short pain scale.
Measured: 5 minutes post LLLT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startFeb 2013
- Primary completionNov 2015
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Milanesi Holanda, University of Nove de Julho
- Investigators
- Maria Cristina Chavantes, PhD, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529657
- Sponsor's protocol ID
- 12288113.1.0000.5511
- Acronym
- LASPINE
- Status last verified
- Jun 2018
- First submitted
- 22 Nov 2013
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farrokhi MR, Vasei M, Fareghbal S, Farrokhi N. The effect of methylene blue on peridural fibrosis formation after laminectomy in rats: an experimental novel study. Spine J. 2011 Feb;11(2):147-52. doi: 10.1016/j.spinee.2011.01.014.
PubMed 21296299Yildiz KH, Gezen F, Is M, Cukur S, Dosoglu M. Mitomycin C, 5-fluorouracil, and cyclosporin A prevent epidural fibrosis in an experimental laminectomy model. Eur Spine J. 2007 Sep;16(9):1525-30. doi: 10.1007/s00586-007-0344-8. Epub 2007 Mar 27.
PubMed 17387523Temiz C, Temiz P, Sayin M, Ucar K. Effect of cepea extract-heparin and allantoin mixture on epidural fibrosis in a rat hemilaminectomy model. Turk Neurosurg. 2009 Oct;19(4):387-92.
PubMed 19847760Oehmichen M. Vitality and time course of wounds. Forensic Sci Int. 2004 Sep 10;144(2-3):221-31. doi: 10.1016/j.forsciint.2004.04.057.
PubMed 15364394Shah JM, Omar E, Pai DR, Sood S. Cellular events and biomarkers of wound healing. Indian J Plast Surg. 2012 May;45(2):220-8. doi: 10.4103/0970-0358.101282.
PubMed 23162220Wang R, Ghahary A, Shen Q, Scott PG, Roy K, Tredget EE. Hypertrophic scar tissues and fibroblasts produce more transforming growth factor-beta1 mRNA and protein than normal skin and cells. Wound Repair Regen. 2000 Mar-Apr;8(2):128-37. doi: 10.1046/j.1524-475x.2000.00128.x.
PubMed 10810039Lee JH, Lee SH. Clinical effectiveness of percutaneous adhesiolysis using Navicath for the management of chronic pain due to lumbosacral disc herniation. Pain Physician. 2012 May-Jun;15(3):213-21.
PubMed 22622905Tao H, Fan H. Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Eur Spine J. 2009 Aug;18(8):1202-12. doi: 10.1007/s00586-009-1013-x. Epub 2009 Apr 30.
PubMed 19404691Sobottke R, Schluter-Brust K, Kaulhausen T, Rollinghoff M, Joswig B, Stutzer H, Eysel P, Simons P, Kuchta J. Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur Spine J. 2009 Oct;18(10):1494-503. doi: 10.1007/s00586-009-1081-y. Epub 2009 Jun 27.
PubMed 19562386Sandoval MA, Hernandez-Vaquero D. Preventing peridural fibrosis with nonsteroidal anti-inflammatory drugs. Eur Spine J. 2008 Mar;17(3):451-455. doi: 10.1007/s00586-007-0580-y. Epub 2008 Jan 3.
PubMed 18172695Rochkind S, Drory V, Alon M, Nissan M, Ouaknine GE. Laser phototherapy (780 nm), a new modality in treatment of long-term incomplete peripheral nerve injury: a randomized double-blind placebo-controlled study. Photomed Laser Surg. 2007 Oct;25(5):436-42. doi: 10.1089/pho.2007.2093.
PubMed 17975958Bae CS, Lim SC, Kim KY, Song CH, Pak S, Kim SG, Jang CH. Effect of Ga-as laser on the regeneration of injured sciatic nerves in the rat. In Vivo. 2004 Jul-Aug;18(4):489-95.
PubMed 15369190Keskin F, Esen H. Comparison of the effects of an adhesion barrier and chitin on experimental epidural fibrosis. Turk Neurosurg. 2010 Oct;20(4):457-63. doi: 10.5137/1019-5149.JTN.3205-10.2.
PubMed 20963694LaRocca H, Macnab I. The laminectomy membrane. Studies in its evolution, characteristics, effects and prophylaxis in dogs. J Bone Joint Surg Br. 1974 Aug;56B(3):545-50. No abstract available.
PubMed 4421702
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Effect of Low Level Laser Therapy in Spinal Surgery
- ClinicalTrials.gov ID
- NCT02529657
- Acronym / sponsor ID
- LASPINE / 12288113.1.0000.5511
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- Lower Level Laser Therapy (LLLT), inflammation, cytokines, wound healing, laminectomy, clinical study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 20 Aug 2015 (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.
Each year, more than one million individuals worldwide are submitted to laminectomies, with a failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause of ''failed back surgery syndrome'' and associated with increased risk of complications during revision surgery. The postoperative epidural scar can cause extradural compression or dural tethering, which results in recurrent radicular pain and physical impairment. Several studies in the literature are signalizing that Low-Level-Laser-Therapy (LLLT) is proven to be an effective tool to assist the inflammatory process and wound healing, as well to prevent infection. Thus, the objectives of this project are to delineate and evaluate the LLLT effects in spinal surgery. A prospective randomized, controlled trial with a total of 48 patients who underwent laminectomy, were divided into 2 groups. In the first group, 25 patients received LLLT during the surgical procedure over dura mater, over subcutaneous and on the skin, as well as 24h and 72h post surgery. In the second group, 23 patients were induced to think they will be getting the same treatment, although the laser is not operating. In those groups, C reactive protein, Lactate Dehydrogenase and Creatine kinase were evaluated in the second and fifth days after surgery, digital temperature will be measured and scores in visual analogue scale will be used, 5 minutes pre and 5 minutes post Laser application. The drainage output was collected in the first three days following surgery in both groups. Interleukins were evaluated in interstitial infiltrate drained in 24h and 48h. The data was evaluated for normality and subjected to appropriate statistical analysis, in order to seek representation, as same as the level of significance of the studied samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: Placebo23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating. |
| Low level Laser Therapy | Experimental | Radiation: Low Level Laser Therapy25 patients were submitted to spine surgery and have received low level laser therapy during surgery, 24 hours after surgery and 48 hours after surgery. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing to lumbar laminectomy
Key exclusion criteria (4 listed)
- Active lumbar cancer
- Infectious disease
- Coagulation disorders
- Dural injury during the surgery
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 TherapyIn 23 randomized patients, LLLT (B-Cure, Good Energies ®, Israel), with CW diode laser - semiconductor Gallium Arsenide and aluminum (GaAlAs) will be applied during surgery (λ = 804 nm ± 2 , total exposure time of 240 s, energy density of 2.48 J/cm2 , average power of 40 mW , spot area of 3,876 cm2), in contact mode, for 60 seconds on the laminectomy site, 60 seconds and 120 seconds in the subcutaneous tissue of the skin over the wound bed, respectively. In the first and second day post surgery, will be collected the drainage output for analysis of interleukin 1, 4, 6, 8 and 10 (IL- 1, IL-4, IL -6, IL-8 and IL -10 ) and tumor necrosis factor alpha ( TNF -alpha ). | Radiation | Low level Laser Therapy |
| PlaceboIn the operating room, lumbar laminectomy will be performed in 46 patients. During the surgery, 24 hours and 48 hours after surgery, the patients received the regular treatment after laminectomy and were induced to thing that were receiving low level laser therapy in their wound. | Procedure or surgery | Placebo |
Primary outcome
Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours
Time frame: 24 hours after surgery
Interstitial infiltrate obtained of Lumbar Drain collected 24 hours after surgery, interleukins IL-1, IL-4, IL-8, IL-10 and TNF alfa were measured through Immunochemistry, using ELISA.
Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery
Time frame: 48h after surgery
Interstitial infiltrate was obtained of Lumbar Drain collected 48 hours after surgery, in this infiltrate interleukins IL-1, IL-4, IL-8, IL10 and TNF alfa were measured through Immunochemistry, using ELISA.
2 secondary outcomes
Score in Visual Analogue Scale
Time frame: 5 minutes pre LLLT
Score in Visual Analogue Scale
Time frame: 5 minutes post LLLT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Background: PubMed 21296299Farrokhi MR, Vasei M, Fareghbal S, Farrokhi N. The effect of methylene blue on peridural fibrosis formation after laminectomy in rats: an experimental novel study. Spine J. 2011 Feb;11(2):147-52. doi: 10.1016/j.spinee.2011.01.014.
- Background: PubMed 17387523Yildiz KH, Gezen F, Is M, Cukur S, Dosoglu M. Mitomycin C, 5-fluorouracil, and cyclosporin A prevent epidural fibrosis in an experimental laminectomy model. Eur Spine J. 2007 Sep;16(9):1525-30. doi: 10.1007/s00586-007-0344-8. Epub 2007 Mar 27.
- Background: PubMed 19847760Temiz C, Temiz P, Sayin M, Ucar K. Effect of cepea extract-heparin and allantoin mixture on epidural fibrosis in a rat hemilaminectomy model. Turk Neurosurg. 2009 Oct;19(4):387-92.
- Background: PubMed 15364394Oehmichen M. Vitality and time course of wounds. Forensic Sci Int. 2004 Sep 10;144(2-3):221-31. doi: 10.1016/j.forsciint.2004.04.057.
- Background: PubMed 23162220Shah JM, Omar E, Pai DR, Sood S. Cellular events and biomarkers of wound healing. Indian J Plast Surg. 2012 May;45(2):220-8. doi: 10.4103/0970-0358.101282.
- Background: PubMed 10810039Wang R, Ghahary A, Shen Q, Scott PG, Roy K, Tredget EE. Hypertrophic scar tissues and fibroblasts produce more transforming growth factor-beta1 mRNA and protein than normal skin and cells. Wound Repair Regen. 2000 Mar-Apr;8(2):128-37. doi: 10.1046/j.1524-475x.2000.00128.x.
- Background: PubMed 22622905Lee JH, Lee SH. Clinical effectiveness of percutaneous adhesiolysis using Navicath for the management of chronic pain due to lumbosacral disc herniation. Pain Physician. 2012 May-Jun;15(3):213-21.
- Background: PubMed 19404691Tao H, Fan H. Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Eur Spine J. 2009 Aug;18(8):1202-12. doi: 10.1007/s00586-009-1013-x. Epub 2009 Apr 30.
- Background: PubMed 19562386Sobottke R, Schluter-Brust K, Kaulhausen T, Rollinghoff M, Joswig B, Stutzer H, Eysel P, Simons P, Kuchta J. Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur Spine J. 2009 Oct;18(10):1494-503. doi: 10.1007/s00586-009-1081-y. Epub 2009 Jun 27.
- Background: PubMed 18172695Sandoval MA, Hernandez-Vaquero D. Preventing peridural fibrosis with nonsteroidal anti-inflammatory drugs. Eur Spine J. 2008 Mar;17(3):451-455. doi: 10.1007/s00586-007-0580-y. Epub 2008 Jan 3.
- Background: PubMed 17975958Rochkind S, Drory V, Alon M, Nissan M, Ouaknine GE. Laser phototherapy (780 nm), a new modality in treatment of long-term incomplete peripheral nerve injury: a randomized double-blind placebo-controlled study. Photomed Laser Surg. 2007 Oct;25(5):436-42. doi: 10.1089/pho.2007.2093.
- Background: PubMed 15369190Bae CS, Lim SC, Kim KY, Song CH, Pak S, Kim SG, Jang CH. Effect of Ga-as laser on the regeneration of injured sciatic nerves in the rat. In Vivo. 2004 Jul-Aug;18(4):489-95.
- Related InfoLink provided by the sponsor.
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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.
Maria Cristina Chavantes, PhD principal investigator
Nove de Julho University
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 Failed Back Surgery Syndrome, run by University of Nove de Julho at 1 site in Brazil.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jun 2018. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours (time frame: 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529657, which also lists 14 linked publications.
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 18 Jun 2018; AzTrials last refreshed its copy on 31 Oct 2026.