This trial is active, not recruiting.

Condition failed back surgery syndrome
Treatments low level laser therapy, placebo
Sponsor University of Nove de Julho
Start date February 2013
End date November 2015
Trial size 48 participants
Trial identifier NCT02529657, 12288113.1.0000.5511


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
(Placebo Comparator)
23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating.
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.
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.
low level laser therapy
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 ).

Primary Outcomes

Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours
time frame: 24 hours after surgery
Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery
time frame: 48h after surgery

Secondary Outcomes

Score in Visual Analogue Scale
time frame: 5 minutes pre LLLT
Score in Visual Analogue Scale
time frame: 5 minutes post LLLT

Eligibility Criteria

Male or female participants from 10 years up to 90 years old.

Inclusion Criteria: - Patients undergoing to lumbar laminectomy Exclusion Criteria: - Active lumbar cancer - Infectious disease - Coagulation disorders - Dural injury during the surgery

Additional Information

Official title Analysis of Effect of Low Level Laser Therapy in Spinal Surgery
Principal investigator Maria Cristina Chavantes, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Nove de Julho.