Photobiomodulation Therapy on Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Device: PBMT active; Device: Placebo PBMT

• Registration Number: NCT03089424
• Lead Sponsor: Universidade Cidade de Sao Paulo

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.

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.

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Study Start: 2017-04-06
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Disability	4 weeks after randomization	Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Pain Intensity	4 weeks after randomization	Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

Secondary Outcome Measures

Name	Time	Method
Function	4 weeks, 3, 6 and 12 months after randomization	Function will be measured by an 11-point (0-10) Patient-Specific Functional Scale
Disability	3, 6 and 12 months after randomization	Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Pain intensity	3, 6 and 12 months after randomization	Pain intensity will be measured by an 11-poin (0-10) Numerical Rating Scale (Pain NRS)
Global perceived effect	4 weeks, 3, 6 and 12 months after randomization	Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Trial Locations

Locations (1)

Centre for Excellence in Clinical Research in Physiotherapy of Universidade Cidade de São Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil