Measurement and Treatment of Back Pain

Not Applicable

Active, not recruiting

• Conditions: Back Pain
• Interventions: Device: Laser; Device: Positive Pressure and Laser; Device: Ultrasound and Laser; Device: Placebo Laser; Device: Negative pressure and Laser

• Registration Number: NCT06245863
• Lead Sponsor: State University of Minas Gerais

Brief 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.

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 Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-12-20
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-08
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Laser	Infrared Laser on back pain.
Positive Pressure and Laser: Combined Therapy	Positive Pressure and Laser	Rollers combined with laser on back pain.
Ultrasound and Laser: Combined Therapy	Ultrasound and Laser	Ultrasound combined with laser on back pain.
Placebo Laser	Placebo Laser	The placebo laser treatment.
Negative pressure and Laser: Combined Therapy	Negative pressure and Laser	Vacuum therapy combined with laser on back pain.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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).
Algometry - Pressure threshold measurement	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.
Dynamometry - Strenght measurement	1 day and 7 weeks	Isometric trunk strength using dynamometer. Data obtained in Newton. greater the value, greater the strength.

Secondary Outcome Measures

Name	Time	Method
Anamnesis	1 day	Questionnaire to get the clinical characteristics of patients.
Waist-hip ratio (WHR) measurement	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).
Body mass index (BMI) measurement	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.
Body composition measurement	1 day	Body composition was performed to evaluate the hydration and the body fat percentage using bipolar bioimpedance.
Quality of life assessment	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.
Flexibility of the spine	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.
Goniometry - Angular measurement	1 day and 7 weeks	Active goniometry was performed to assess range of motion (ROM) of the spine (angular measure).
Shoulder mobility measurement	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.
Well-being assessment	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".

Trial Locations

Locations (1)

Fernanda Rossi Paolillo; 🇧🇷 Passos, Minas Gerais, Brazil