Measurement and Treatment of Back Pain

Measurement and Treatment With Laser and Mechanical Systems to Treat 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Back Pain
• Intervention / Treatment: Device: Laser; Device: Placebo Laser; Device: Negative pressure and Laser; Device: Positive Pressure and Laser; Device: Ultrasound and Laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Passos, Minas Gerais, Brazil, 37902092
      • Fernanda Rossi Paolillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laser; Infrared Laser on back pain.	Device: 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 Comparator: Placebo Laser; The placebo laser treatment.	Device: 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.
Experimental: Negative pressure and Laser: Combined Therapy; Vacuum therapy combined with laser on back pain.	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.
Experimental: Positive Pressure and Laser: Combined Therapy; Rollers combined with laser on back pain.	Device: 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.
Experimental: Ultrasound and Laser: Combined Therapy; Ultrasound combined with laser on back pain.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Dynamometry - Strenght measurement	Isometric trunk strength using dynamometer. Data obtained in Newton. greater the value, greater the strength.	1 day and 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anamnesis	Questionnaire to get the clinical characteristics of patients.	1 day
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
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
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
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
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
Body composition measurement	Body composition was performed to evaluate the hydration and the body fat percentage using bipolar bioimpedance.	1 day
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
Goniometry - Angular measurement	Active goniometry was performed to assess range of motion (ROM) of the spine (angular measure).	1 day and 7 weeks

Collaborators and Investigators

• Sponsor: State University of Minas Gerais
• Collaborators: Fundação de Amparo à Pesquisa do estado de Minas Gerais
• Investigators: Principal Investigator: Fernanda R Paolillo, PhD, State University of Minas Gerais

Publications and helpful links

General Publications

• 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):e202200260. doi: 10.1002/jbio.202200260. Epub 2023 Jan 2.
• 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. Epub 2020 Sep 28.
• 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.
• 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 Trial. J Acupunct Meridian Stud. 2021 Dec 31;14(6):219-230. doi: 10.51507/j.jams.2021.14.6.219.
• 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 17;12:e20. doi: 10.34172/jlms.2021.20. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: Back Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No