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Low Back PainNCT03089424

Photobiomodulation Therapy on Low Back Pain

A study testing PBMT active in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Photobiomodulation therapy (PBMT) is a non-pharmacological method commonly used in treatment of musculoskeletal disorders. However, there are few high-quality scientific evidence to support the effectiveness of this therapy in the treatment of patients with chronic low back pain, at short, medium and long term. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
PBMT active
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
1 siteBrazil
Study dates
6 Apr 2017to 20 Jun 2019
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);
  • with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;
  • aged between 18 and 65 years;
  • able to read Portuguese.

Who cannot join

  • evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);
  • serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);
  • serious cardiovascular and metabolic diseases;
  • previous back surgery;
  • pregnancy.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centre for Excellence in Clinical Research in Physiotherapy of Universidade Cidade de São Paulo

    São Paulo, São Paulo, 03071000

Other trials in Brazil

About this study

Official title: Effects of Photobiomodulation Therapy in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial

Photobiomodulation therapy (PBMT) is a non-pharmacological method commonly used in treatment of musculoskeletal disorders. However, there are few high-quality scientific evidence to support the effectiveness of this therapy in the treatment of patients with chronic low back pain, at short, medium and long term. The present research project aims to evaluate the effects of PBMT in patients with chronic non-specific low back pain.

Read the detailed description

This is a randomized, triple-blinded, placebo-controlled trial, with voluntary patients with chronic non-specific low back pain.One hundred and forty-eight patients will be randomly allocated to two treatment groups: Placebo or PBMT for 4 weeks (3 times per week, total of 12 sessions of 27 minutes each). The clinical outcomes will be obtained at the completion of treatment (4 weeks) and at 3, 6 and 12 months after randomization. The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by using mixed linear models.

The outcomes of interest are pain intensity, disability, function and global perceived effect.

Conditions
Low Back Pain
Being tested
Placebo PBMT, PBMT active
Keywords
low back pain, photobiomodulation therapy, LLLT
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo PBMTDevice

    The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (without any dose, 0 J); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (without any dose, 0 J). Patients will be treated during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 0 J. At the end of the 12 treatment sessions, patients will receive a total dose of 0 J.

  • PBMT activeDevice

    The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (3000 Hz of frequency, 3 minutes of irradiation per site, 24.75 J per site, a totalizing 74.25 J irradiated from SE25); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (1000 Hz of frequency, 3 minutes of irradiation per site, 24.30 J per site, a total of 145.80 J irradiated from LS50). Patients will be treated during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 220.05 J. At the end of the 12 treatment sessions, patients will receive a total dose of 2640.60 J.

Study groups in NCT03089424
Study groupRoleWhat they receive
Placebo PBMTPlacebo comparatorApplication of PBMT (Photobiomodulation Therapy) without any dose (0 Joule) and The Back Book (educational information booklet).
Receives: Device: Placebo PBMT
PBMT activeActive comparatorApplication of PBMT (Photobiomodulation Therapy) active and The Back Book (educational information booklet).
Receives: Device: PBMT active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity

    Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

    Measured: 4 weeks after randomization

  2. Disability

    Disability will be measured by the 24-item Roland Morris Disability Questionnaire

    Measured: 4 weeks after randomization

Secondary outcomes (4)

  1. Pain intensity

    Pain intensity will be measured by an 11-poin (0-10) Numerical Rating Scale (Pain NRS)

    Measured: 3, 6 and 12 months after randomization

  2. Disability

    Disability will be measured by the 24-item Roland Morris Disability Questionnaire

    Measured: 3, 6 and 12 months after randomization

  3. Function

    Function will be measured by an 11-point (0-10) Patient-Specific Functional Scale

    Measured: 4 weeks, 3, 6 and 12 months after randomization

  4. Global perceived effect

    Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

    Measured: 4 weeks, 3, 6 and 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start6 Apr 2017
  3. Primary completion4 Jun 2019
  4. Study completion20 Jun 2019

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03089424
Sponsor's protocol ID
1.964.094
Status last verified
Sep 2020
First submitted
20 Mar 2017
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guimaraes LS, Costa LDCM, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, Leal-Junior ECP, Costa LOP, Tomazoni SS. Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial. Pain. 2021 Jun 1;162(6):1612-1620. doi: 10.1097/j.pain.0000000000002189.

    PubMed 33449509

  • Tomazoni SS, Costa LDCM, Guimaraes LS, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, Costa LOP. Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial. BMJ Open. 2017 Oct 24;7(10):e017202. doi: 10.1136/bmjopen-2017-017202.

    PubMed 29070637

Questions about this trial

What is this clinical trial studying?

A study testing PBMT active in people with Low Back Pain, run by Universidade Cidade de Sao Paulo 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 4 inclusion and 5 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 16 Sep 2020. 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: 4 weeks after randomization). The study lists 2 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 NCT03089424, which also lists 2 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 16 Sep 2020.

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