Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery (LASPINE)

University of Nove de Julho

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Procedure: Placebo; Radiation: Low Level Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02529657

12288113.1.0000.5511

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 10 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing to lumbar laminectomy

Exclusion criteria

• Active lumbar cancer
• Infectious disease
• Coagulation disorders
• Dural injury during the surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating.

Treatment:

Procedure: Placebo

Low level Laser Therapy

Experimental group

Description:

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.

Treatment:

Radiation: Low Level Laser Therapy