Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery
- Conditions
- Failed Back Surgery Syndrome
- Interventions
- Procedure: PlaceboRadiation: Low Level Laser Therapy
- Registration Number
- NCT02529657
- Lead Sponsor
- University of Nove de Julho
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Patients undergoing to lumbar laminectomy
- Active lumbar cancer
- Infectious disease
- Coagulation disorders
- Dural injury during the surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating. Low level Laser Therapy Low Level Laser Therapy 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.
- Primary Outcome Measures
Name Time Method Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours 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 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.
- Secondary Outcome Measures
Name Time Method Score in Visual Analogue Scale 5 minutes post LLLT Change from baseline in pain on the 11 point short pain scale.
Trial Locations
- Locations (1)
Nove de Julho Universtiy
🇧🇷Sao Paulo, São Paulo, Brazil