Ignite Creation Date:
2024-05-06 @ 8:41 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02793401
Status:
COMPLETED
Last Update Posted:
2016-06-08
First Post:
2016-05-20
Brief Title:
Chronic Shoulder Pain Treatment High Intensity Laser or Ultrasound
Sponsor:
Bursa Yüksek İhtisas Education and Research Hospital
Organization:
Bursa Yüksek İhtisas Education and Research Hospital
Study Overview
Official Title:
A Comparison of the Efficacy of High Intensity Laser and Ultrasound Therapies in Patients With Chronic Shoulder Pain A Randomized Controlled Single Blind Study
Status:
COMPLETED
Status Verified Date:
2016-06
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 investigators aimed to evaluate the short-term efficacy of High Intensity LASER Therapy HILT and Ultrasound US treatment in chronic shoulder pain Its a prospective randomized controlled single blind study141 patients were randomized into two groups as HILT n71 and US n70 groups HILT or US treatment was applied to the patients in addition to 14 sessions of Hotpack Hp Balneotherapy Exercise treatment Pre-treatment Pre-T Post-treatment 1st day Post-T1st day and Post-T findings for the 30th day Post-T 30th day were recorded using the visual analog scale VAS and shoulder pain and disability index SPADI scoring
Detailed Description:
Chronic shoulder pain which negatively affects the quality of life due to pain and loss of functions is the third most common painful condition of the musculoskeletal system1 The aim of the study was to determine more effective conventional physical treatment method HILT or US for pain and daily activities of patients with chronic shoulder pain which was difficult to treat and had unfavorable effects on patient life quality This prospective randomized controlled single blind study was conducted at the Physical Treatment and Rehabilitation Training and Research Hospital and ethics board approval was obtainedA total of 210 patients who presented to the hospital with chronic shoulder pain were evaluated for inclusion in the study Patients to be included in the study were divided into two groups by the investigating physician using simple randomization and their treatment was organized Forms detailing the patients demographics VAS scores and SPADI were completed by another investigating physician who was blind to the type of treatment the patients would receive The same investigating physician completed Post-treatment 1st day Post-T1st day and Post-T findings for the 30th day Post-T 30th day forms and recorded the data Patients who were randomly divided into two groups received treatment for two weeks 14 days are shown below
Group 1 Hotpack HP Balneotherapy Exercise HILT
Group 2 Hotpack HP Balneotherapy Exercise US
Patients in both groups received HP to the affected shoulder region for 20 minutes and balneotherapy in mineral water pool at 38-400C for 20 minutes for seven consecutive days ROM exercises and Codman exercises in a level not to increase the severity of the pain of the patient were given and stretching and strengthening exercises were taught to the patientsThe patients performed these exercises daily in two sets with five repeats in each set
HILT was performed using a BTL-6000 High Intensity Laser 12 Wwatt 1064 nm device was a hot laser with Nd YAG LASER source BTL 4710 US device was applied at 3 MHz frequency and 15wattcm2 intensity over 25 cm2 surface area Headpiece area of the device was 5 cm2 and the application was performed as the head of device was positioned at 90º perpendicular at full contact for 5 minutes by using gel and performing continuous circular motions Patients were evaluated using VAS and SPADI in pre-treatment Pre-T Post-T1st day and Post-T 30th day
Group 1 Hotpack HP Balneotherapy Exercise HILT
Group 2 Hotpack HP Balneotherapy Exercise US
Patients in both groups received HP to the affected shoulder region for 20 minutes and balneotherapy in mineral water pool at 38-400C for 20 minutes for seven consecutive days ROM exercises and Codman exercises in a level not to increase the severity of the pain of the patient were given and stretching and strengthening exercises were taught to the patientsThe patients performed these exercises daily in two sets with five repeats in each set
HILT was performed using a BTL-6000 High Intensity Laser 12 Wwatt 1064 nm device was a hot laser with Nd YAG LASER source BTL 4710 US device was applied at 3 MHz frequency and 15wattcm2 intensity over 25 cm2 surface area Headpiece area of the device was 5 cm2 and the application was performed as the head of device was positioned at 90º perpendicular at full contact for 5 minutes by using gel and performing continuous circular motions Patients were evaluated using VAS and SPADI in pre-treatment Pre-T Post-T1st day and Post-T 30th day
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