Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery

Официальное название

Utilizing Photobiomodulation Via Laser Diode Belts To Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery

Обзор

After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients. Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace.

Подробное описание

This study will review charts of 80 patients who have experienced chronic back pain at various operative sites of a teaching medical institution, including the inpatient academic medical center, outpatient ambulatory hospital, and regional trauma center. Deidentified demographic data that will be collected via extensive chart reviews include age, sex, BMI, preoperative diagnosis, pre- and post-operative pain scales, motor exams, and function questionnaires. Operative data will include operative time and estimated blood loss (EBL).

Patients that have already expressed interest in receiving spinal fusion or decompression surgery will come into clinic for consultation and enrollment in the study. Regardless of study participation, patients will receive either surgery. For the study, 80 subjects will be enrolled (40 with minimally invasive spinal fusion and 40 with minimally invasive decompression surgeries). Prior to the surgery date, subjects will complete pre-operation questionnaires that include the Visual Analogue Scale (VAS) and the Oswestry-Low-Back-Pain-Disability Index (ODI) to self-evaluate their current pain level and ability to perform basic lifestyle functions, respectively. Following surgery, enrolled subjects will then receive a brace that contains laser diodes or a sham (placebo) brace that appears identical to the diode-containing brace but lacks functional diodes. Subjects will wear the brace 3 times/day for 12 minutes each session for 12 weeks. They will complete and submit via the REDCap electronic submission portal the VAS and ODI questionnaires at the following time points after surgery: 2, 4, 6, 8, and 12 weeks. Subjects will also submit photos of their surgical scars for evaluation by the research study team members. Scar and wound healing will be assessed using image analysis software (Image J) according to the Stony Brook Scar Evaluation scale. Photos will be stored on a safe and secure encrypted server.

Вмешательства

• Устройство Laser Diode Brace
  The device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.
• Устройство Sham Laser Diode Brace
  The Sham brace has no therapeutic ability and will act as a placebo.

Первичные конечные точки

• Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS [Срок оценки: 3 months]
• Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Stony Brook Scar Evaluation [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Subject will have undergone minimally invasive spinal fusion surgery or spinal decompression surgery in their lower back L1-S1.
• Have low back pain of >3 months and a pain threshold of > 4 (as described by the the subject), age > 18 years, and English speaking to eliminate possible miscommunication and consequent human error regarding belt use.
• Subject must have had surgery at minimum to 1 year prior to start of study and no more than 5 years prior to start to study

Критерии исключения

• Patients with tumors
• Current infection
• Drug misuse history
• Skin conditions preclude the use of laser belt
• Severe spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis
• Previous low back surgery exceeding 5 years to initial start date.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Semel Institute of Neuroscience at UCLA — Los Angeles
• UCLA Clinical and Translational Research Center — Los Angeles

Идентификаторы

NCT: NCT06282770 · IRB#23-000444

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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