Fernanda Rossi Paolillo
Passos, Minas Gerais, 37902092, Brazil
NCT Number: NCT06245863
The aim of this study was to evaluate the clinical aspects and to investigate the therapeutic effects of combined therapy with laser on back pain.
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Notify Me20 year–85 year
All sexes
Interventional
Not applicable
Passos, Minas Gerais, 37902092, Brazil
Dysfunctions of the musculoskeletal system are related to physiological, kinesiological and biomechanical factors that result in pain, paresthesia, inflammation, heaviness, fatigue and compression of peripheral nerves. Clinical aspects related to back pain were investigated. For treatment, photobiomodulation can be performed with laser equipment that emits red and infrared light, which promotes analgesic and anti-inflammatory effects. Mechanical stimulus can be combined with laser to improve therapeutical effects. In this context, the laser was combined with ultrasound, negative pressure and positive pressure to treat back pain.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Synergistic application (single handle) - Laser: Red (660 nm) and infrared (808 nm) lasers, continuous mode, 100 milliwatts (mW) per laser. Vacuum therapy: 60 mm suction cup, pulsed mode (MP9, 50 pulsations per minute) and pressure of -150 at -350 mbar. The treatment was carried out during 20 minutes on the lumbar, thoracic and cervical spine regions. Seven sessions were performed.
Synergistic application (single handle) - Laser: Red (660 nm) and infrared (808 nm) lasers, continuous mode, 100 mW per laser. Positive Pressure: Massage with rollers. The treatment was carried out during 20 minutes on the lumbar, thoracic and cervical spine regions. Seven sessions were performed.
Synergistic application (single handle) - Laser: Red (660 nm) and infrared (808 nm) lasers, continuous mode, 100 mW per laser. Ultrasound: 1 megahertz (MHz), continuous mode and 1 milliwatts per square centimeter (mW/cm2). The treatment was carried out during 20 minutes on the lumbar, thoracic and cervical spine regions. Seven sessions were performed.
Infrared Laser (808 nm), continuous mode, 100 mW. The treatment was carried out during 20 minutes on the lumbar, thoracic and cervical spine regions. Seven sessions were performed.
Laser: off mode. The placebo treatment was carried out during 20 minutes on the lumbar, thoracic and cervical spine regions. Seven sessions were performed.
Time frame: 1 day and 7 weeks
Visual analogue scale (VAS): The volunteer was instructed to give a score for pain intensity between 0 (no pain) and 10 (worst imaginable pain).
Time frame: 1 day and 7 weeks
Pain pressure threshold on low back using algometer. Data obtained in Newton. Higher pressure pain threshold is reported for lower pain sensitivity.
Time frame: 1 day and 7 weeks
Isometric trunk strength using dynamometer. Data obtained in Newton. greater the value, greater the strength.
Time frame: 1 day
Questionnaire to get the clinical characteristics of patients.
Time frame: 1 day
Body mass index: BMI = mass (kg) / height2 (m). Classification: BMI less than 18.5 kg/m2 are underweight, BMI between 18.5 and 24.9 kg/m2 is considered normal weight, BMI between 25 and 29.9 kg/m2 is considered overweight, and BMI ≥ 30 kg/m² is considered obese. Obesity is divided into grades; grade I being a BMI between 30 to 34.9 kg/m², grade II being a BMI 35 to 39.9 kg/m² and grade III BMI ≥ 40 kg/m².
Time frame: 1 day
Waist-hip ratio: WHR = waist (cm) / hips (cm). The anatomical landmarks to measure the circumference (cm), in the upright position of the body were: 1) waist: measured at the above the iliac crest; 2) hip: measured at the largest protuberance of the buttocks. Classification: Gynoid (WHR between 0.68 and 0.8) and Android (WHR>0.8).
Time frame: 1 day
Body composition was performed to evaluate the hydration and the body fat percentage using bipolar bioimpedance.
Time frame: 1 day and 7 weeks
Bilateral range of motion was assessed, combining internal rotation with shoulder adduction and external rotation with abduction of the other shoulder, placing the hand on the central axis of the body in the thoracic region. Three distance measurements were obtained on both sides between the third fingers of the right and left hands to calculate the average.
Time frame: 1 day and 7 weeks
Fingertip-to-floor test was carried out. In upright standing position with knees joint fully extended, the volunteers were instructed to bend forward and attempt to reach for the floor with their fingertips. The distance between the patient's right long finger and the floor were measured using a measuring tape. Three measurements were taken to calculate the average value.
Time frame: 1 day and 7 weeks
Active goniometry was performed to assess range of motion (ROM) of the spine (angular measure).
Time frame: 1 day and 7 weeks
Quality of Life was measured using the World Health Organization Quality of Life-Abbreviated form (WHOQOL-BREF), a 26-item questionnaire in which items are rated on a 5-point scale. It evaluates 4 domains related to physical factors, psychological factors, social relationships, and environmental context. Higher scores indicate a better quality of life.
Time frame: 1 day and 7 weeks
The Subjective Well-Being Scale (EBES) was answered by patients. It is composed of 62 items related to three factors that evaluate subjective well-being: positive affect; negative affection and satisfaction with life versus life dissatisfaction. The first 47 items measure positive and negative affect using a 5-point scale with ratings from "not at all" to "to a great extent". The last 22 items measure life satisfaction (or dissatisfaction) using a 5-point scale with ratings from "strongly disagree" to "strongly agree".
State University of Minas Gerais
Other
Measurement and Treatment With Laser and Mechanical Systems to Treat Back Pain
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