Photobiomodulation Therapy on Low Back Pain

NCT03089424 | Completed

• 1 other identifier: 1.964.094
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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. The present research project aims to evaluate the effects of PBMT in patients with chronic non-specific low back pain.

Conditions

Low Back Pain

Keywords

low back pain, photobiomodulation therapy, LLLT

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

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

  4 weeks after randomization

• Disability

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

  4 weeks after randomization

Secondary Outcomes (4)

• Pain intensity

  3, 6 and 12 months after randomization

• Disability

  3, 6 and 12 months after randomization

• Function

  4 weeks, 3, 6 and 12 months after randomization

• Global perceived effect

  4 weeks, 3, 6 and 12 months after randomization

Study Arms (2)

Placebo PBMT

PLACEBO COMPARATOR

Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule) and The Back Book (educational information booklet).

Device: Placebo PBMT

PBMT active

ACTIVE COMPARATOR

Application of PBMT (Photobiomodulation Therapy) active and The Back Book (educational information booklet).

Device: PBMT active

Interventions

Placebo PBMT DEVICE

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.

Placebo PBMT

PBMT active DEVICE

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.

PBMT active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 03071000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 33449509 DERIVED

• 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.

  PMID: 29070637 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonardo Oliveira Pena Costa, PhD

  Universidade Cidade de Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The mode of intervention (active or placebo photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: April 6, 2017
• Primary Completion: June 4, 2019
• Study Completion: June 20, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)