PBMT in Providing Temporary Relief of Low Back Pain of Musculoskeletal Origin
NCT Number: NCT06549660
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: DEVICE: Active PBMT|DEVICE: Placebo PBMT
Sponsor: University of Nove de Julho
Collaborators: Multi Radiance Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-10-01
Locations: Laboratory of Phototherapy and Innovative Technologies in Health, São Paulo, 01504-001, Brazil

Summary:
The goal of this clinical trial is to evaluate the effectiveness of PBMT for adjunctive use in providing temporary relief of minor chronic low back pain of musculoskeletal origin.

The main questions it aims to answer are:

(i) Is PBMT able to decrease pain intensity in patients with chronic low back pain of musculoskeletal origin? (ii) Is PBMT able to decrease disability in patients with chronic low back pain of musculoskeletal origin?

Researchers will compare active PBMT with placebo PBMT to see if active PBMT provides temporary relief of minor chronic low back pain of musculoskeletal origin.

Primary Outcome Measures: Proportion of individual subject successes, Measured through degree of pain rating measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome., 15 minutes after the final treatment (6th).
Secondary Outcome Measures: Degree of pain, Degree of pain will be measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome., 15 minutes after the final treatment (6th) and one month after the final treatment.|Disability, Disability will be measured by the 24-item Roland Morris Disability Questionnaire. The questionnaire consists of 24 items that patient has to answer 'yes' or 'no'. The minimum value is 0 and the maximum value is 24. Higher scores mean worse outcome., 15 minutes after the final treatment (6th) and one month after the final treatment.
Other Outcome Measures: Subject Satisfaction with overall outcome rating, Patient satisfaction will be measured by 5 point Likert Scale. The scale uses the following responses: very satisfied = 5; somewhat satisfied = 4; neither satisfied nor dissatisfied = 3; somewhat dissatisfied n=2; very dissatisfied =1. Highest scores indicates better satisfaction., 15 minutes after the final treatment (6th) and one month after the final treatment.|Perceived group assignment and rationale, Perceived group assignment and rationale will be measured by the percentage of patients and outcome assessor who correctly perceived their procedure group assignment and the percentage of volunteers and outcome assessor who did not correctly perceive their procedure group., 15 minutes after the final treatment (6th) and one month after the final treatment.|Adverse events, All adverse events that occur after randomization, including but not limiting, skin irritation, discoloration, rash, infection, increased pain or tenderness. The adverse events will be captured on the appropriate adverse event case report form., 15 minutes after the final treatment (6th) and one month after the final treatment.