Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829734
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2021-03-29
Brief Title:
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Evaluation of the Effects of Photobiomodulation Therapy Combined With Static Magnetic Field PBMT-sMF on Temporary Pain Relief in Patients With Lateral Epicondylitis
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
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:
Lateral epicondylitis LE is one of the most frequently encountered lesions affecting the upper extremity and is the most common cause of elbow pain in adults It occurs on the lateral side of the elbow where the common extensors originate from the lateral epicondyle LE can be considered an overuse injury which occurs on the lateral side of the elbow in the extensor tendons with repetitive micro-trauma The clinical presentation of LE involves a painful or burning sensation over the humeral insertion of the common extensor tendons Despite the high incidence of LE optimal treatment has not been established Treatment options include therapeutic exercise bracing shock wave or ultrasound therapy but many of them lack sufficient evidence of beneficial effects Photobiomodulation therapy PBMT alone or combined with static magnetic field PBMT-sMF has been shown to stimulate tendon healing this suggests that therapy using laser or light-emitting diodes LEDs is efficacious for the symptoms associated with epicondylitis According to the favorable results of PBMT-sMF in tendons repair processes this type of therapy can be used as a therapeutic tool for management in epicondylitis therefore more investigations are necessary to establish the ideal parameters Therefore the aim of this project is to investigate the effects of PBMT-sMF in the appropriate parameters on degree of pain and quality of life of patients with lateral epicondylitis
Detailed Description:
To achieve the proposed objective it will be performed a multi-center randomized triple-blinded placebo-controlled trial with voluntary patients with lateral epicondylitis Fifty patients will be randomly allocated to two treatment groups 1 Active PBMT-sMF MR5 Prototype Device or Placebo PBMT-sMF MR5 Prototype Device The patients will be treated by a blinded therapist
The patients randomly allocated to the different groups will be subjected to treatment two times a week for three consecutive weeks each procedure administration three to four days apart
The study will contain five phases 1 pre-procedure activities 2 pre-procedure assessment phase 3 procedure administration phase 4 procedure administration phase measures 5 post-procedure administration phase
The outcomes measured will be degree of pain forearm pain and disability grip strength TNF-α levels subject satisfaction with overall outcome rating perceived group assignment and adverse events
The outcomes will be obtained at the stabilization phase pre-procedure activities baseline pre-procedure assessment phase 24 hours after the end of the treatment procedure administration phase measures and 30 days after the end of the treatment post-procedure administration phase
Statistical analysis
1 The primary statistical method to analyze the primary endpoint will be Fishers exact test to compare the proportion of success between the test Active PBMT-sMF and the control Placebo PBMT-sMF groups considering that randomization has been diligently conducted and important covariates between the two groups are well balanced Statistical significance will be set at p005
2 The secondary outcomes that are continuous variables will be analyzed through parametric analysis using ANCOVA Statistical significance will be set at p005
3 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 will be set at p005
The patients randomly allocated to the different groups will be subjected to treatment two times a week for three consecutive weeks each procedure administration three to four days apart
The study will contain five phases 1 pre-procedure activities 2 pre-procedure assessment phase 3 procedure administration phase 4 procedure administration phase measures 5 post-procedure administration phase
The outcomes measured will be degree of pain forearm pain and disability grip strength TNF-α levels subject satisfaction with overall outcome rating perceived group assignment and adverse events
The outcomes will be obtained at the stabilization phase pre-procedure activities baseline pre-procedure assessment phase 24 hours after the end of the treatment procedure administration phase measures and 30 days after the end of the treatment post-procedure administration phase
Statistical analysis
1 The primary statistical method to analyze the primary endpoint will be Fishers exact test to compare the proportion of success between the test Active PBMT-sMF and the control Placebo PBMT-sMF groups considering that randomization has been diligently conducted and important covariates between the two groups are well balanced Statistical significance will be set at p005
2 The secondary outcomes that are continuous variables will be analyzed through parametric analysis using ANCOVA Statistical significance will be set at p005
3 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 will be set at p005
Study Oversight
Has Oversight DMC:
None
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?:
None