Measurement and Treatment of Back Pain

NCT ID: NCT06245863

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-08-20

Brief Summary

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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

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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.

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Negative pressure and Laser: Combined Therapy

Vacuum therapy combined with laser on back pain.

Group Type EXPERIMENTAL

Negative pressure and Laser

Intervention Type 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: Combined Therapy

Rollers combined with laser on back pain.

Group Type EXPERIMENTAL

Positive Pressure and Laser

Intervention Type 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: Combined Therapy

Ultrasound combined with laser on back pain.

Group Type EXPERIMENTAL

Ultrasound and Laser

Intervention Type 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

Infrared Laser on back pain.

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type 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

The placebo laser treatment.

Group Type PLACEBO_COMPARATOR

Placebo Laser

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

State University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Fernanda Rossi Paolillo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernanda R Paolillo, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Minas Gerais

Locations

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Fernanda Rossi Paolillo

Passos, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 36520347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33992253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32208577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35770601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34733743 (View on PubMed)

Other Identifiers

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Back Pain

Identifier Type: -

Identifier Source: org_study_id

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