Back PainNCT06245863
Measurement and Treatment of Back Pain
A study testing Negative pressure and Laser, Positive Pressure and Laser and Ultrasound and Laser in people with Back Pain, run by State University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Negative pressure and Laser, Positive Pressure and Laser and Ultrasound and Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2023to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers (female and male)
- Aged between 20 and 60 years
- Who had medical referral for pain complaint in low back
Who cannot join
- Psychiatric illnesses
- Endocrinopathies
- Heart diseases
- Neurological diseases
- Osteoporosis
- Cancer
- Analgesic, anti-inflammatory or muscle relaxant drugs in the last four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Negative pressure and Laser, Positive Pressure and Laser, Ultrasound and Laser, Laser, Placebo Laser
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure and Laser: Combined Therapy | Experimental | Vacuum therapy combined with laser on back pain. Receives: Device: Negative pressure and Laser |
| Positive Pressure and Laser: Combined Therapy | Experimental | Rollers combined with laser on back pain. Receives: Device: Positive Pressure and Laser |
| Ultrasound and Laser: Combined Therapy | Experimental | Ultrasound combined with laser on back pain. Receives: Device: Ultrasound and Laser |
| Laser | Active comparator | Infrared Laser on back pain. Receives: Device: Laser |
| Placebo Laser | Placebo comparator | The placebo laser treatment. Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 day and 7 weeks
Dynamometry - Strenght measurement
Isometric trunk strength using dynamometer. Data obtained in Newton. greater the value, greater the strength.
Measured: 1 day and 7 weeks
Secondary outcomes (9)
Anamnesis
Questionnaire to get the clinical characteristics of patients.
Measured: 1 day
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.
Measured: 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).
Measured: 1 day
Body composition measurement
Body composition was performed to evaluate the hydration and the body fat percentage using bipolar bioimpedance.
Measured: 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.
Measured: 1 day and 7 weeks
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.
Measured: 1 day and 7 weeks
Goniometry - Angular measurement
Active goniometry was performed to assess range of motion (ROM) of the spine (angular measure).
Measured: 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.
Measured: 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".
Measured: 1 day and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Mar 2023
- Primary completion20 Dec 2023
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Fernanda Rossi Paolillo, State University of Minas Gerais
- Investigators
- Fernanda R Paolillo, PhD, Principal investigator, State University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245863
- Sponsor's protocol ID
- Back Pain
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36520347Paolillo 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.
PubMed 33992253Mroczek 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.
PubMed 32208577Salemi 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.
PubMed 35770601Kenareh 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.
PubMed 34733743Santos ATS, Terra AMSV, Parizotto NA, Bagnato VS, Paolillo FR. Effects of Photobiomodulation by Laser and Mechanical Systems on Low Back Pain: A Longitudinal, Randomized, Placebo-Controlled Clinical Trial. J Biophotonics. 2026 Jun;19(6):e70299. doi: 10.1002/jbio.70299.
PubMed 42206653Chaves DIA, de Jesus MAC, de Menezes GD, Souza LMV, Goncalves GH, Paolillo FR. Rehabilitation of back pain with laser associated with negative or positive pressure massage in workers: A randomized controlled trial. J Bodyw Mov Ther. 2025 Mar;41:101-108. doi: 10.1016/j.jbmt.2024.11.032. Epub 2024 Nov 17.
PubMed 39663074
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Treatment With Laser and Mechanical Systems to Treat Back Pain
- ClinicalTrials.gov ID
- NCT06245863
- Acronym / sponsor ID
- Back Pain
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- State University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Negative pressure and Laser: Combined Therapy | Experimental | Device: Negative pressure and LaserVacuum therapy combined with laser on back pain. |
| Positive Pressure and Laser: Combined Therapy | Experimental | Device: Positive Pressure and LaserRollers combined with laser on back pain. |
| Ultrasound and Laser: Combined Therapy | Experimental | Device: Ultrasound and LaserUltrasound combined with laser on back pain. |
| Laser | Active comparator | Device: LaserInfrared Laser on back pain. |
| Placebo Laser | Placebo comparator | Device: Placebo LaserThe placebo laser treatment. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers (female and male)
- Aged between 20 and 60 years
- Who had medical referral for pain complaint in low back
Key exclusion criteria (7 listed)
- Psychiatric illnesses
- Endocrinopathies
- Heart diseases
- Neurological diseases
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure and LaserSynergistic 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. | Device | Negative pressure and Laser: Combined Therapy |
| Positive Pressure and LaserSynergistic 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. | Device | Positive Pressure and Laser: Combined Therapy |
| Ultrasound and LaserSynergistic 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. | Device | Ultrasound and Laser: Combined Therapy |
| LaserInfrared 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. | Device | Laser |
| Placebo LaserLaser: off mode. The placebo treatment was carried out during 20 minutes on the lumbar, thoracic and cervical spine regions. Seven sessions were performed. | Device | Placebo Laser |
Primary outcome
Pain Intensity
Time frame: 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
Time frame: 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
Time frame: 1 day and 7 weeks
Isometric trunk strength using dynamometer. Data obtained in Newton. greater the value, greater the strength.
9 secondary outcomes
Anamnesis
Time frame: 1 day
Body mass index (BMI) measurement
Time frame: 1 day
Waist-hip ratio (WHR) measurement
Time frame: 1 day
Body composition measurement
Time frame: 1 day
Shoulder mobility measurement
Time frame: 1 day and 7 weeks
Flexibility of the spine
Time frame: 1 day and 7 weeks
Goniometry - Angular measurement
Time frame: 1 day and 7 weeks
Quality of life assessment
Time frame: 1 day and 7 weeks
Well-being assessment
Time frame: 1 day and 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 36520347Paolillo 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.
- Results publication: PubMed 33992253Paolillo 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.
- Results publication: PubMed 32208577Mroczek 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.
- Results publication: PubMed 35770601Salemi 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.
- Results publication: PubMed 34733743Kenareh 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.
- Derived from this study: PubMed 42206653Santos ATS, Terra AMSV, Parizotto NA, Bagnato VS, Paolillo FR. Effects of Photobiomodulation by Laser and Mechanical Systems on Low Back Pain: A Longitudinal, Randomized, Placebo-Controlled Clinical Trial. J Biophotonics. 2026 Jun;19(6):e70299. doi: 10.1002/jbio.70299.
- Derived from this study: PubMed 39663074Chaves DIA, de Jesus MAC, de Menezes GD, Souza LMV, Goncalves GH, Paolillo FR. Rehabilitation of back pain with laser associated with negative or positive pressure massage in workers: A randomized controlled trial. J Bodyw Mov Ther. 2025 Mar;41:101-108. doi: 10.1016/j.jbmt.2024.11.032. Epub 2024 Nov 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda R Paolillo, PhD principal investigator
State University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure and Laser, Positive Pressure and Laser and Ultrasound and Laser in people with Back Pain, run by State University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 1 day and 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06245863, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.