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Completed

NCT Number: NCT06245863

Measurement and Treatment of Back Pain

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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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fernanda Rossi Paolillo

Passos, Minas Gerais, 37902092, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers (female and male)
  • Aged between 20 and 60 years
  • Who had medical referral for pain complaint in low back

Exclusion criteria

  • Psychiatric illnesses
  • Endocrinopathies
  • Heart diseases
  • Neurological diseases
  • Osteoporosis
  • Cancer
  • Analgesic, anti-inflammatory or muscle relaxant drugs in the last four weeks

Treatment and study plan

Negative pressure and Laser

Device

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.

Positive Pressure and Laser

Device

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.

Ultrasound and Laser

Device

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.

laser

Device

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.

Placebo Laser

Device

Laser: off mode. The placebo treatment was carried out during 20 minutes on the lumbar, thoracic and cervical spine regions. Seven sessions were performed.

Primary outcomes

  1. Pain Intensity

    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).

  2. Algometry - Pressure threshold measurement

    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.

  3. Dynamometry - Strenght measurement

    Time frame: 1 day and 7 weeks

    Isometric trunk strength using dynamometer. Data obtained in Newton. greater the value, greater the strength.

Secondary outcomes

  1. Anamnesis

    Time frame: 1 day

    Questionnaire to get the clinical characteristics of patients.

  2. Body mass index (BMI) measurement

    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.

  3. Waist-hip ratio (WHR) measurement

    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).

  4. Body composition measurement

    Time frame: 1 day

    Body composition was performed to evaluate the hydration and the body fat percentage using bipolar bioimpedance.

  5. Shoulder mobility measurement

    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.

  6. Flexibility of the spine

    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.

  7. Goniometry - Angular measurement

    Time frame: 1 day and 7 weeks

    Active goniometry was performed to assess range of motion (ROM) of the spine (angular measure).

  8. Quality of life assessment

    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.

  9. Well-being assessment

    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".

Sponsors and collaborators

Lead sponsor

State University of Minas Gerais

Other

Collaborators

  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Official study title

Measurement and Treatment With Laser and Mechanical Systems to Treat Back Pain

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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