Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04322812 |
Other study ID # |
2.732.062 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 31, 2020 |
Est. completion date |
October 30, 2020 |
Study information
Verified date |
June 2021 |
Source |
University of Nove de Julho |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Fibromyalgia (FM) syndrome is defined by the American College of Rheumatology (ACR), as a
chronic widespread pain and tenderness in at least eleven of eighteen specific tender points.
Despite the increased understanding about FM, there is currently no cure for this syndrome
and the treatment aims to provide symptomatic relief and improvement of physical capacities
to perform daily tasks and quality of life. Evidence has suggest that photobiomodulation
therapy (PBMT) can be used as monotherapy or as a supplementary treatment to other
therapeutic procedures in patients with FM. However, the lack of consensus regarding
therapeutic protocols hinders multicenter comparisons of the many clinical trials published.
Further studies are needed to establish ideal parameters of PBMT to be used as a therapeutic
tool in the management of fibromyalgia. Therefore, the aim of this project is to investigate
the effectiveness of PBMT combined with static magnetic fields (sMF) in pain relief in
patients with fibromyalgia.
Description:
To achieve the proposed objectives it will be performed a randomized, triple-blind,
placebo-controlled trial, with voluntary patients with fibromyalgia. Ninety patients will be
randomly allocated to two treatment groups: 1. Active PBMT (MR5™ ACTIV PRO LaserShower) or
Placebo PBMT (MR5™ ACTIV PRO LaserShower). The patients will be treated by a blinded
therapist.
The patients randomly allocated to the different groups will be subjected to treatment 3
times a week, total of 9 sessions (with approximately 48 hours between each session), a total
of 3 weeks of treatment.
The clinical outcomes will be obtained at the stabilization phase, baseline, end of treatment
and 30 days after the conclusion of treatment.
The data will be collected by a blinded assessor.
Statistical analyzis:
- The primary statistical method to analyze the primary endpoint will be Fisher's Exact
Test to compare the proportion of success between the test (Active PBMT) and the control
procedure (Placebo PBMT) groups, considering that randomization has been diligently
conducted and important covariates between the two groups are well balanced. Statistical
significance is set at p < 0.05.
- Unpaired T test will be applied to analyze pain intensity through EVA. Mean and
individual subject changes in VAS ratings across and between all study evaluation
time-points, within and between procedure groups considering that randomization has been
diligently conducted and important covariates between the two groups are well balanced.
Statistical significance is set at p<0.05.
- For patient satisfaction, measured through a Likert Scale, the data will be reduced to
the nominal level by combining all agree and disagree responses into two categories of
"accept" and "reject". Differences in satisfaction with Study Outcome Ratings between
procedure groups at both evaluated time-points, and any change between. The chi-square,
will be used after this transformation. Statistical significance is set at p<0.05.
The investigators will analyze: degree of pain rating (tender point count), pain intensity,
patient satisfaction and adverse events