Clinical trial NCT06245863: Measurement and Treatment of Back Pain
Official title: Measurement and Treatment With Laser and Mechanical Systems to Treat Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Back Pain
Lead sponsor: State University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2024-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: 1 day and 7 weeks
measure: Algometry - Pressure threshold measurement
timeFrame: 1 day and 7 weeks
measure: Dynamometry - Strenght measurement
timeFrame: 1 day and 7 weeks
Secondary outcomes:
measure: Anamnesis
timeFrame: 1 day
measure: Body mass index (BMI) measurement
timeFrame: 1 day
measure: Waist-hip ratio (WHR) measurement
timeFrame: 1 day
measure: Body composition measurement
timeFrame: 1 day
measure: Shoulder mobility measurement
timeFrame: 1 day and 7 weeks
measure: Flexibility of the spine
timeFrame: 1 day and 7 weeks
measure: Goniometry - Angular measurement
timeFrame: 1 day and 7 weeks
measure: Quality of life assessment
timeFrame: 1 day and 7 weeks
measure: Well-being assessment
timeFrame: 1 day and 7 weeks
Other outcomes:
Locations:
city: Passos
country: Brazil
facility: Fernanda Rossi Paolillo
state: Minas Gerais
Study officials:
affiliation: State University of Minas Gerais
name: Fernanda R Paolillo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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):e202200260. doi: 10.1002/jbio.202200260. Epub 2023 Jan 2.
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. Epub 2020 Sep 28.
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.
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 Trial. J Acupunct Meridian Stud. 2021 Dec 31;14(6):219-230. doi: 10.51507/j.jams.2021.14.6.219.
citation: 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.