NCT06245863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

January 19, 2024

Last Update Submit

August 30, 2025

Conditions

Back Pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Anamnesis

    1 day

  • Body mass index (BMI) measurement

    1 day

  • Waist-hip ratio (WHR) measurement

    1 day

  • Body composition measurement

    1 day

  • Shoulder mobility measurement

    1 day and 7 weeks

  • +4 more secondary outcomes

Study Arms (5)

Negative pressure and Laser: Combined Therapy

EXPERIMENTAL

Vacuum therapy combined with laser on back pain.

Device: Negative pressure and Laser

Positive Pressure and Laser: Combined Therapy

EXPERIMENTAL

Rollers combined with laser on back pain.

Device: Positive Pressure and Laser

Ultrasound and Laser: Combined Therapy

EXPERIMENTAL

Ultrasound combined with laser on back pain.

Device: Ultrasound and Laser

Laser

ACTIVE COMPARATOR

Infrared Laser on back pain.

Device: Laser

Placebo Laser

PLACEBO COMPARATOR

The placebo laser treatment.

Device: Placebo Laser

Interventions

Negative pressure and LaserDEVICE

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.

Negative pressure and Laser: Combined Therapy
Positive Pressure and LaserDEVICE

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.

Positive Pressure and Laser: Combined Therapy
Ultrasound and LaserDEVICE

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.

Ultrasound and Laser: Combined Therapy
LaserDEVICE

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.

Laser
Placebo LaserDEVICE

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

Placebo Laser

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers (female and male)
  • Aged between 20 and 60 years
  • Who had medical referral for pain complaint in low back

You may not qualify if:

  • Psychiatric illnesses
  • Endocrinopathies
  • Heart diseases
  • Neurological diseases
  • Osteoporosis
  • Cancer
  • Analgesic, anti-inflammatory or muscle relaxant drugs in the last four weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fernanda Rossi Paolillo

Passos, Minas Gerais, 37902092, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 36520347BACKGROUND

  • 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.

    PMID: 33992253BACKGROUND

  • 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.

    PMID: 32208577BACKGROUND

  • 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.

    PMID: 35770601BACKGROUND

  • 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.

    PMID: 34733743BACKGROUND

MeSH Terms

Conditions

Back Pain

Interventions

LasersUltrasonography

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and SuppliesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Fernanda R Paolillo, PhD

    State University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2024

First Posted

February 7, 2024

Study Start

March 1, 2023

Primary Completion

December 20, 2023

Study Completion

August 20, 2024

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)