Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651775
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
Effectiveness of High Intensity Laser Therapy HILT in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of High Intensity Laser Therapy HILT in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation
Status:
RECRUITING
Status Verified Date:
2024-10
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 aim of this intervention study is to investigate the effects of High Intensity Laser Therapy HILT on the patients disability functionality and neuropathic and nociceptive pattern of pain in chronic radicular pain due to lumbar disc herniation and its superiority over conventional electrotherapy modalities that we commonly use
The main question it aims to answer is
What is the short and long term effect of high intensity laser therapy on low back and leg pain in patients with chronic lumbar radiculopathy due to disc herniation
35 patients in group A will receive the planned Hotpack TENS High Intensity Laser Therapy HILT and exercise treatments for lumbar radicular low back pain In group B comparison group 35 patients will receive Hotpack TENS sham HILT and exercise treatments
Participants will receive 15 sessions of treatment and exercises will be given as a home program Both groups will complete questionnaires about disability life functions and pain before and after treatment and at the 3rd month follow-up
The main question it aims to answer is
What is the short and long term effect of high intensity laser therapy on low back and leg pain in patients with chronic lumbar radiculopathy due to disc herniation
35 patients in group A will receive the planned Hotpack TENS High Intensity Laser Therapy HILT and exercise treatments for lumbar radicular low back pain In group B comparison group 35 patients will receive Hotpack TENS sham HILT and exercise treatments
Participants will receive 15 sessions of treatment and exercises will be given as a home program Both groups will complete questionnaires about disability life functions and pain before and after treatment and at the 3rd month follow-up
Detailed Description:
Efficacy of High Intensity Laser Therapy in Patients with Chronic Lumbar Radiculopathy Due to Disc Herniation Ankara 2025
Low back pain is an important and widespread health problem that negatively affects the quality of life from past to present causes deterioration in functional status and may cause disability and psychologically wears out human health in the chronic period In epidemiological studies the prevalence of low back pain has been found to be approximately 40 throughout life
Low back pain is classified as acute subacute and chronic according to its duration and as mechanical and inflammatory according to the character of the pain Low back pain lasting more than 12 weeks is defined as chronic low back pain
Etiological factors include fracture malignancy infection trauma osteoporosis inflammatory diseases myogenic causes etc One of the most important and common causes of mechanical causes is intervertebral disc herniation Disc herniation may also cause radicular pain in the form of numbness burning electrification pins and needles in the dermatome area of the related nerve due to neural root compression
There are many treatment modalities for radicular low back pain due to lumbar disc herniation These include medical treatment lumbar and abdominal strengthening exercises given outside the acute painful period physical therapy modalities alternative medicine methods laser therapy epidural steroid injections and surgical treatment
The term laser is defined as light amplification by stimulated radiation emission It is a non-invasive and painless treatment There are two types of laser therapy low and high intensity with different intensity according to peak power and wavelength Pulsed neodymium-doped yttrium aluminium garnet NdYAG high intensity laser HILT works with high peak power and 1064nm wavelength The laser has 5 basic mechanisms of action thermal mechanical electrical photochemical biostimulate Biostimulation antiedema analgesic and anti-inflammatory effects in the applied area are more pronounced due to its high intensity and specific wavelength but the exact mechanism of action in reducing pain has not yet been clearly clarified
This study aimed to investigate the effects of high-intensity laser therapy HILT on the patients disability functionality and neuropathic and nociceptive patterns of pain in radicular pain due to lumbar disc herniation in the chronic period and its superiority over the conventional electrotherapy modalities we frequently use The study was designed as a randomised placebo-controlled double-blind prospective study
This study includes patients admitted to the outpatient clinics of Ankara City Hospital Physical Medicine and Rehabilitation Hospital who have low back pain radiating to the lower extremities for more than 12 weeks and have sensory deficit andor pain sensation in dermatomal distribution due to radicular lesion accompanying lumbar disc herniation shown by lumbar MRI Patients will be randomly divided into two groups
A total of 70 patients aged 18-65 years of male and female sex will be included in the study and the patients will be randomly divided into two groups of equal number
Patients in Group A n35 will receive 15 sessions of hotpack and 15 sessions of TENS transcutaneous electrical nerve stimulation five days a week for 3 weeks 15 sessions of HIRO TT ASA Laser Arcugnano Italy device in lumbosciatica mode in three phases fast scanning trigger point slow scanning over an area of 25 cm² Isometric lumbar strengthening and core stabilisation exercises will be given to the patients as a home programme
Patients in group B n35 will receive TENS Transcutaneous Electrical Nerve Stimulation Hotpack Lumbar and Core Stabilisation Exercises and sham High Intensity Laser treatments and the protocols will be the same as in group A Patients will be evaluated 3 times in total pre-treatment post-treatment and 3 months
Low back pain is an important and widespread health problem that negatively affects the quality of life from past to present causes deterioration in functional status and may cause disability and psychologically wears out human health in the chronic period In epidemiological studies the prevalence of low back pain has been found to be approximately 40 throughout life
Low back pain is classified as acute subacute and chronic according to its duration and as mechanical and inflammatory according to the character of the pain Low back pain lasting more than 12 weeks is defined as chronic low back pain
Etiological factors include fracture malignancy infection trauma osteoporosis inflammatory diseases myogenic causes etc One of the most important and common causes of mechanical causes is intervertebral disc herniation Disc herniation may also cause radicular pain in the form of numbness burning electrification pins and needles in the dermatome area of the related nerve due to neural root compression
There are many treatment modalities for radicular low back pain due to lumbar disc herniation These include medical treatment lumbar and abdominal strengthening exercises given outside the acute painful period physical therapy modalities alternative medicine methods laser therapy epidural steroid injections and surgical treatment
The term laser is defined as light amplification by stimulated radiation emission It is a non-invasive and painless treatment There are two types of laser therapy low and high intensity with different intensity according to peak power and wavelength Pulsed neodymium-doped yttrium aluminium garnet NdYAG high intensity laser HILT works with high peak power and 1064nm wavelength The laser has 5 basic mechanisms of action thermal mechanical electrical photochemical biostimulate Biostimulation antiedema analgesic and anti-inflammatory effects in the applied area are more pronounced due to its high intensity and specific wavelength but the exact mechanism of action in reducing pain has not yet been clearly clarified
This study aimed to investigate the effects of high-intensity laser therapy HILT on the patients disability functionality and neuropathic and nociceptive patterns of pain in radicular pain due to lumbar disc herniation in the chronic period and its superiority over the conventional electrotherapy modalities we frequently use The study was designed as a randomised placebo-controlled double-blind prospective study
This study includes patients admitted to the outpatient clinics of Ankara City Hospital Physical Medicine and Rehabilitation Hospital who have low back pain radiating to the lower extremities for more than 12 weeks and have sensory deficit andor pain sensation in dermatomal distribution due to radicular lesion accompanying lumbar disc herniation shown by lumbar MRI Patients will be randomly divided into two groups
A total of 70 patients aged 18-65 years of male and female sex will be included in the study and the patients will be randomly divided into two groups of equal number
Patients in Group A n35 will receive 15 sessions of hotpack and 15 sessions of TENS transcutaneous electrical nerve stimulation five days a week for 3 weeks 15 sessions of HIRO TT ASA Laser Arcugnano Italy device in lumbosciatica mode in three phases fast scanning trigger point slow scanning over an area of 25 cm² Isometric lumbar strengthening and core stabilisation exercises will be given to the patients as a home programme
Patients in group B n35 will receive TENS Transcutaneous Electrical Nerve Stimulation Hotpack Lumbar and Core Stabilisation Exercises and sham High Intensity Laser treatments and the protocols will be the same as in group A Patients will be evaluated 3 times in total pre-treatment post-treatment and 3 months
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