Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637410
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Effectiveness of High Intensity Laser Treatment In Partial Supraspinatus Tendon Tears
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of High Intensity Laser Treatment in Partial Supraspinatus Tendon Tears A Randomised Controlled Trial
Status:
COMPLETED
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:
HILT
Brief Summary:
The primary goal of this clinical trial is to compare the effects of High Intensity Laser Therapy HILT on tears of tendons of shoulder girdle muscles with those of Ultrasound US therapy It will also learn about the effects of HILT on pain and range of motion of injured shoulder The main questions it aims to answer are
Does HILT decrease the debilitating pain Does HILT increase the range of motion of the sholuder joint How long does the effect of HILT continue
Researchers will compare the effects of HILT to a control group ultrasound therapy group an established method of treatment in shoulder girdle tendon tears to see if HILT works better to treat shoulder girdle tendon tears
Participants will
receive HILT or US therapy 3 sessions per week for 3 weeks in addition to the therapeutic exercise program
Visit the clinic at the beginning at the 4th week and at the 12th week to determine the level of pain and disability via application of surveys
Tendon thickness of participants will also be measured at the beginning at the 4th week and at the 12th week to see if the treatment works to heal the tear
Does HILT decrease the debilitating pain Does HILT increase the range of motion of the sholuder joint How long does the effect of HILT continue
Researchers will compare the effects of HILT to a control group ultrasound therapy group an established method of treatment in shoulder girdle tendon tears to see if HILT works better to treat shoulder girdle tendon tears
Participants will
receive HILT or US therapy 3 sessions per week for 3 weeks in addition to the therapeutic exercise program
Visit the clinic at the beginning at the 4th week and at the 12th week to determine the level of pain and disability via application of surveys
Tendon thickness of participants will also be measured at the beginning at the 4th week and at the 12th week to see if the treatment works to heal the tear
Detailed Description:
Shoulder disorders are one of the most common musculoskeletal problems worldwide After low back pain and knee pain shoulder pain has been estimated to be the third most common musculoskeletal presentation in primary care Shoulder joint is surrounded by rotator cuff muscles and rotator cuff tendinopathy is the most common cause of shoulder pain Shoulder pain caused by partial supraspinatus tendon tear STT is a complex and challenging issue for clinicians The choice of the most appropriate treatment management for these tears is controversial
For Ellman grade I and II tears which comprise STTs of less than 50 or tears which are below 6 mm in thickness strengthening exercises ultrasound US therapy physical therapy injection treatment and medical treatment can provide improvement in patients However in grade III tears which involve STTs of more than 50 of the muscle or tears above 6 mm in thickness surgical treatment may be required
Recently high-intensity laser therapy HILT has been introduced and used in treatment of musculoskeletal disorders There is no universally accepted theory that explains the exact mechanism of the postulated laser effects yet NdYAG laser which has a wavelength of 1064 nm is used in HILT It works in a therapeutic window that has a low absorbability rate in superficial tissue layers so it penetrates more deeply than other types of lasers In addition to having a higher power than low-intensity lasers lasers used in HILT have a shorter laser emission time and a longer laser emission interval Therefore a large amount of laser irradiation can be delivered to deep tissues The utilization of HILT has been expanding and patients have reported significant improvement in function and reduction of pain
To our knowledge no studies to date have been conducted on the effects of HILT on partial STT The aim of the present study was to evaluate the long-term effectiveness of HILT on pain disability and range of motion in patients with shoulder pain caused by STT and to compare its effects to those of US therapy
The current study was designed as a prospective randomized controlled clinical trial and conducted after approval from the local ethics committee of our medical center The study was conducted in accordance with the principles of Declaration of Helsinki and registered in the government database The patients were recruited from the Ankara Bilkent City Hospital physical medicine and rehabilitation outpatient clinic
For Ellman grade I and II tears which comprise STTs of less than 50 or tears which are below 6 mm in thickness strengthening exercises ultrasound US therapy physical therapy injection treatment and medical treatment can provide improvement in patients However in grade III tears which involve STTs of more than 50 of the muscle or tears above 6 mm in thickness surgical treatment may be required
Recently high-intensity laser therapy HILT has been introduced and used in treatment of musculoskeletal disorders There is no universally accepted theory that explains the exact mechanism of the postulated laser effects yet NdYAG laser which has a wavelength of 1064 nm is used in HILT It works in a therapeutic window that has a low absorbability rate in superficial tissue layers so it penetrates more deeply than other types of lasers In addition to having a higher power than low-intensity lasers lasers used in HILT have a shorter laser emission time and a longer laser emission interval Therefore a large amount of laser irradiation can be delivered to deep tissues The utilization of HILT has been expanding and patients have reported significant improvement in function and reduction of pain
To our knowledge no studies to date have been conducted on the effects of HILT on partial STT The aim of the present study was to evaluate the long-term effectiveness of HILT on pain disability and range of motion in patients with shoulder pain caused by STT and to compare its effects to those of US therapy
The current study was designed as a prospective randomized controlled clinical trial and conducted after approval from the local ethics committee of our medical center The study was conducted in accordance with the principles of Declaration of Helsinki and registered in the government database The patients were recruited from the Ankara Bilkent City Hospital physical medicine and rehabilitation outpatient clinic
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