Ignite Creation Date:
2025-12-18 @ 8:29 AM
Ignite Modification Date:
2025-12-23 @ 9:57 PM
Study NCT ID:
NCT04322812
Status:
None
Last Update Posted:
2021-06-11 00:00:00
First Post:
2020-03-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Fibromyalgia
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of the Effects of Photobiomodulation Therapy (PBMT) Combined With Static Magnetic Field (sMF) on Temporary Pain Relief in Fibromyalgia Patients: a Randomized Placebo-controlled Trial
Status:
None
Status Verified Date:
2021-06
Last Known Status:
None
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:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: