Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT04476095
Status:
UNKNOWN
Last Update Posted:
2020-07-17
First Post:
2020-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)
Sponsor:
University of Nove de Julho
Organization:
Study Overview
Official Title:
Effects of Photobiomodulation Therapy (PBMT) on Pain Intensity in Patients With Low Back Pain (LBP)
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low back pain (LBP) is a highly prevalent condition worldwide and the leading cause of years lived with disability. In most cases, the specific pathological cause remains unidentified; therefore, the term non-specific low back pain is commonly used for such cases. Many non-pharmacological therapies are available for the treatment of low back pain aiming to reduce pain and disability. Among these options, photobiomodulation therapy (PBMT) it seems to be an interesting alternative. PBMT is a non-thermal and non-invasive clinical treatment, which has shown effects in decreased pain, modulation of inflammatory process, and tissue repair in musculoskeletal disorders. Therefore, the aim of this project is to evaluate the effects of the PBMT against placebo on pain intensity in patients with chronic non-specific low back pain.
Detailed Description:
To achieve the proposed objective, it will be performed a randomized, triple-blind (patients, therapists, and outcome assessors), placebo-controlled trial.
Seventy-two patients with chronic non-specific low back pain will be randomly allocated to two treatment groups: 1. Active PBMT or Placebo PBMT.
In both groups, six treatment sessions will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period. The patients will be treated by a blinded therapist.
The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion of treatment. The data will be collected by a blinded assessor.
Statistical analyzis:
* The Fischer's Exact Test will be conducted to compare the proportion of successes between groups.
* The Unpaired t-test will be used for demographic data.
* Repeated measures ANOVA will be performed to analyze pain intensity. The level of statistical significance will be set at p\<0.05.
Seventy-two patients with chronic non-specific low back pain will be randomly allocated to two treatment groups: 1. Active PBMT or Placebo PBMT.
In both groups, six treatment sessions will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period. The patients will be treated by a blinded therapist.
The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion of treatment. The data will be collected by a blinded assessor.
Statistical analyzis:
* The Fischer's Exact Test will be conducted to compare the proportion of successes between groups.
* The Unpaired t-test will be used for demographic data.
* Repeated measures ANOVA will be performed to analyze pain intensity. The level of statistical significance will be set at p\<0.05.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: