Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-30
Brief Title:
Pompage and Photobiomodulation on Pain Range of Motion and Quality of Life in Patients With Neck Pain
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Effects of Pompage Associated or Not With Photobiomodulation on Pain Range of Motion and Quality of Life in Patients With Neck Pain a Controlled Randomized and Double Blinded Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The aim of this study is to evaluate the effects of Pompage associated or not with PBM using a cluster of LEDs on pain and neck disability This controlled randomized and double-blinded clinical study includes participants of both genders aged 18 to 55 with non-specific chronic neck pain will be included Participants will be randomized into two groups 1 Pompage n28 focusing only on manual therapy through Pompage technique and 2 Pompage PBM Group n28 involving the same procedures as the first group followed by PBM with a LED cluster applied for 10 minutes to the neck region for 10 sessions Pain and functional disability will be assessed using the visual analog scale VAS and Neck Pain Disability Index before and after the intervention The resulting data will be submitted to statistical analysis considering α005
Detailed Description:
Chronic neck pain is a persistent condition affecting the spinal region resulting in pain and restricted mobility The management of neck pain often involves manual therapies encompassing both passive and active interventions aimed at alleviating pain enhancing function improving mobility motor control and reducing inflammatory processes This pain can persist for at least three months and is considered non-specific when it is not associated with any specific underlying condition such as inflammatory rheumatic disease osteoporosis cancer or radiculopathy
The use of lasers and LEDs for photobiomodulation PBM represents an advantageous approach to treating neck pain given their demonstrated therapeutic efficacy in the literature Moreover these resources are non-invasive and easy to apply making them an attractive option for both patients and healthcare professionals Therefore the aim of this study is to evaluate the effects of Pompage associated or not with PBM using a cluster of LEDs on pain and neck disability This controlled randomized and double-blinded clinical study includes participants of both genders aged 18 to 55 with non-specific chronic neck pain will be included Participants will be randomized into two groups 1 Pompage n28 focusing only on manual therapy through Pompage technique and 2 Pompage PBM Group n28 involving the same procedures as the first group followed by PBM with a LED cluster applied for 10 minutes to the neck region The treatment protocol consists of 10 sessions three times weekly excluding weekends For PBM a cluster comprising 264 LEDs 8 mW 489J 96 Jcm2 16 mWcm² per LED will be used with 132 red 660nm and 132 infrared 850nm LEDs Pain and functional disability will be assessed using the visual analog scale VAS and Neck Pain Disability Index before and after the intervention The resulting data will be submitted to statistical analysis considering α005
The use of lasers and LEDs for photobiomodulation PBM represents an advantageous approach to treating neck pain given their demonstrated therapeutic efficacy in the literature Moreover these resources are non-invasive and easy to apply making them an attractive option for both patients and healthcare professionals Therefore the aim of this study is to evaluate the effects of Pompage associated or not with PBM using a cluster of LEDs on pain and neck disability This controlled randomized and double-blinded clinical study includes participants of both genders aged 18 to 55 with non-specific chronic neck pain will be included Participants will be randomized into two groups 1 Pompage n28 focusing only on manual therapy through Pompage technique and 2 Pompage PBM Group n28 involving the same procedures as the first group followed by PBM with a LED cluster applied for 10 minutes to the neck region The treatment protocol consists of 10 sessions three times weekly excluding weekends For PBM a cluster comprising 264 LEDs 8 mW 489J 96 Jcm2 16 mWcm² per LED will be used with 132 red 660nm and 132 infrared 850nm LEDs Pain and functional disability will be assessed using the visual analog scale VAS and Neck Pain Disability Index before and after the intervention The resulting data will be submitted to statistical analysis considering α005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None