Measurement and Treatment of Back Pain

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06245863
• Other study ID #: Back Pain
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: February 2024
• Source: State University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Fernanda Rossi Paolillo	Passos	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
State University of Minas Gerais	Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Kenareh R, Mirmohammadi SJ, Khatibi A, Shamsi F, Mehrparvar AH. The Comparison of The Efficacy of Photobiomodulation and Ultrasound in the Treatment of Chronic Non-specific Neck Pain: A Randomized Single-Blind Controlled Trial. J Lasers Med Sci. 2021 May — View Citation

Mroczek B, Lubkowska W, Jarno W, Jaraczewska E, Mierzecki A. Occurrence and impact of back pain on the quality of life of healthcare workers. Ann Agric Environ Med. 2020 Mar 17;27(1):36-42. doi: 10.26444/aaem/115180. Epub 2019 Dec 30. — View Citation

Paolillo FR, Lobo da Costa PH, Mendes PVB, Cruz DMCD, Paolillo AR, Bagnato VS. Effects of the infrared laser on classical ballerinas' feet: Analysis of plantar foot and static balance. J Bodyw Mov Ther. 2021 Apr;26:246-252. doi: 10.1016/j.jbmt.2020.09.007 — View Citation

Paolillo FR, Luccas GAA, Parizotto NA, Paolillo AR, de Castro Neto JC, Bagnato VS. The effects of transcranial laser photobiomodulation and neuromuscular electrical stimulation in the treatment of post-stroke dysfunctions. J Biophotonics. 2023 Apr;16(4):e — View Citation

Salemi MM, Gomes VMDSA, Bezerra LMR, Melo TMS, Alencar GG, Montenegro IHPM, Calado APM, Montenegro EJN, Siqueira GR. Effect of Dry Cupping Therapy on Pain and Functional Disability in Persistent Non-Specific Low Back Pain: A Randomized Controlled Clinical — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Visual analogue scale (VAS): The volunteer was instructed to give a score for pain intensity between 0 (no pain) and 10 (worst imaginable pain).	1 day and 7 weeks
Primary	Algometry - Pressure threshold measurement	Pain pressure threshold on low back using algometer. Data obtained in Newton. Higher pressure pain threshold is reported for lower pain sensitivity.	1 day and 7 weeks
Primary	Dynamometry - Strenght measurement	Isometric trunk strength using dynamometer. Data obtained in Newton. greater the value, greater the strength.	1 day and 7 weeks
Secondary	Anamnesis	Questionnaire to get the clinical characteristics of patients.	1 day
Secondary	Body mass index (BMI) measurement	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.	1 day
Secondary	Waist-hip ratio (WHR) measurement	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).	1 day
Secondary	Body composition measurement	Body composition was performed to evaluate the hydration and the body fat percentage using bipolar bioimpedance.	1 day
Secondary	Shoulder mobility measurement	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.	1 day and 7 weeks
Secondary	Flexibility of the spine	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.	1 day and 7 weeks
Secondary	Goniometry - Angular measurement	Active goniometry was performed to assess range of motion (ROM) of the spine (angular measure).	1 day and 7 weeks
Secondary	Quality of life assessment	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.	1 day and 7 weeks
Secondary	Well-being assessment	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".	1 day and 7 weeks