Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549660
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
PBMT in Providing Temporary Relief of Low Back Pain of Musculoskeletal Origin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combination of Super Pulsed Lasers and LEDs PBMT for Adjunctive Use in Providing Temporary Relief of Minor Chronic Low Back Pain of Musculoskeletal Origin
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
To achieve the proposed objective it will be performed a randomized triple-blinded patients therapists and outcome assessors placebo-controlled randomized study
Sixty-eight patients will be randomly allocated to two treatment groups
1 Active treatment Thirty-four patients will receive treatment with active PBMT
2 Placebo treatment Thirty-four patients will receive treatment with placebo PBMT
The treatment administration protocol will comprise six sessions of treatment with active or placebo PBMT according to the previous randomization two sessions a week for three consecutive weeks each procedure administration three to four days apart
The data will be collected by a blinded assessor
The study will comprise the following stagesphases
1 Pre procedure phase activities a signing of informed consent form b assignment of subject identification number c randomization of subject to procedure group d initial study qualification evaluation
2 Rescue pain management stabilization phase a determination and recording of the individualized rescue pain management regimen b VAS recording c continued study eligibility evaluation
3 Pre-procedure administration phase activities a pre-procedure variables recorded b recording of pre-procedure measures
4 Procedure administration phase activities a establishment of procedure administration visit schedule b study procedure administration c study procedure administration protocol d procedure administration phase visits and evaluations
5 Post-procedure administration phase one-month 304 days period immediately following completion of the procedure administration phase
The statistical analysis will follow the intention-to-treat principles as primary analysis and per-protocol analysis will be secondary supportive analysis
Sixty-eight patients will be randomly allocated to two treatment groups
1 Active treatment Thirty-four patients will receive treatment with active PBMT
2 Placebo treatment Thirty-four patients will receive treatment with placebo PBMT
The treatment administration protocol will comprise six sessions of treatment with active or placebo PBMT according to the previous randomization two sessions a week for three consecutive weeks each procedure administration three to four days apart
The data will be collected by a blinded assessor
The study will comprise the following stagesphases
1 Pre procedure phase activities a signing of informed consent form b assignment of subject identification number c randomization of subject to procedure group d initial study qualification evaluation
2 Rescue pain management stabilization phase a determination and recording of the individualized rescue pain management regimen b VAS recording c continued study eligibility evaluation
3 Pre-procedure administration phase activities a pre-procedure variables recorded b recording of pre-procedure measures
4 Procedure administration phase activities a establishment of procedure administration visit schedule b study procedure administration c study procedure administration protocol d procedure administration phase visits and evaluations
5 Post-procedure administration phase one-month 304 days period immediately following completion of the procedure administration phase
The statistical analysis will follow the intention-to-treat principles as primary analysis and per-protocol analysis will be secondary supportive analysis
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?:
None