Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189521
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-12-09
Brief Title:
Lateral Epicondylitis Extracorporeal Shock Wave Therapy Ultrasound Iontophoresis
Sponsor:
Pınar Özge Başaran
Organization:
Hitit University
Study Overview
Official Title:
Comparison of Extracorporeal Shock Wave Therapy Ultrasound and Dexamethasone Iontophoresis in Patients With Lateral Epicondylitis
Status:
COMPLETED
Status Verified Date:
2023-12
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:
Lateral epicondylitis LE is one of the most common causes of non-traumatic elbow pain which develops as a result of repetitive stresses due to overuse of the forearm muscles and is also called tennis elbowConservative treatment options include electrotherapy exercises extracorporeal shock wave therapy ESWT steroid injections platelet rich plasma hyaluronic acid injections As our knowledge this is the first study comparing the three different treatment modalities ESWT Us and Iontophoresis on lateral epicondylitis The aim of our study to evaluate the efficacy of ESWT ultrasound and iontophoresis treatments in terms of pain grip strength functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments against each other
Detailed Description:
This is a prospective randomized single blind clinical study A total of 78 patients age between 18-65 who were diagnosed with lateral epicondylitis between June 2023 and December 2023 were included in our study The study was approved by the University Ethics Committee 2023-77 and written informed consent was obtained from all the patients The study was carried out in accordance with the principles of the Declaration of Helsinki
Patients who had pain at the lateral epicondyle at least for four weeks detection of sensitivity by palpation on the lateral epicondyle and having positivity in at least two of the special tests Cozen test Maudsley test and Mills test were included in the study Physical therapy ESWT or local injections for lateral epicondylitis within the last 3 months the presence of cervical radiculopathy carpal tunnel syndrome other neuropathic diseases neurologic diseases medial epicondylitis systemic inflammatory diseases tenderness or swelling at the ipsilateral extremity and fibromyalgia have been excluded
Patients were randomized into three groups by a physiotherapist with sealed envelopes The researchers were blinded to the patients groups The same physiotherapy program was applied to all groups The physiotherapy program consisted of hot packs and transcutaneus electrical nerve stimulation TENS for 10 minutes and stretching and eccentric strengthening exercises were given to all groups All exercises were done under the supervision of the same physiotherapist
In addition to the ten-day of physiotherapy program in the first group one day for a week a total of 3 sessions of ESWT was applied at 18 bar 100 Hz 2000 beats Elmed Vibrolith Ortho
In the second group ten days of ultrasound applied at 15 wattcm2 continuous mode to the painful area for 5 minutes 5 days a week for two weeks Chattanooga Intelect Advanced
In the third group ten days of dexamethasone iontophoresis therapy was applied 10 days for 10 minutes 01 dexamethasone ophthalmic pomade was applied to the anodal electrode and placed on the lateral epicondyle and 01-02 milliamperecm2 galvanic current was applied in each session ES-522 ITO Physiotherapy and Rehabilitation
Evaluations were conducted at before treatment and one month after treatment in all groups by the same researchers who were blind in treatment groups
The clinical and demographic data of the patients were recorded Numerical Rating Scale NRS was used for the pain assessment The NRS is a subjective measure in which individuals rate their pain on an eleven-point numerical scale The scale is composed of 0 no pain at all to 10 worst imaginable pain It has been shown that a composite scoring system including best worse and current level of pain over the last 24 hours was sufficient to pick up changes in pain intensity with maximal reliabilityJensen et al 1999
The hand grip strength HGS was measured with a Jamar hydraulic hand dynamometer Saehan SH5001 in kilograms This instrument has a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the grip strength of the hand is registered in kilograms Hand and pinch strength were measured by hydraulic pinch gauge Saehan SH5005 This instrument has also a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the pinc strength of the hand is registered in kilograms Upper extremity disability levels were assessed with Quick Disabilities of the Arm Shoulder and Hand QuickDASH The Quick-DASH is an 11-item that measures upper extremity activity limitation and symptoms Items were scored from 1 indicating no functional limitation and no symptoms to 5 indicating functional inability and extreme symptoms The totalscore was computed by transforming the mean items score to a scale from 0 to 100 where 0 indicates the best upper extremity function and no symptoms Turkish version of the test was evaluated
Quality of life was measured by notthingham health profile NHP Scale 6 dimensions total It consists of 38 items Sub-dimensions Energy 3 items pain 8 items emotional status 9 items sleep 5 itemssocial isolation 5 items and physical activity 8 items Its range is 0-100is scored As the score increases health status gets worse The validity and reliability of the Turkish version of the test was evaluated
In the study power analysis performed by examining the related studies in the literature and the sample size required to obtain a significant result was calculated as totally 76 patients 26 patients in each group G-Power v3197 All data were analysed using the Windows 150 Statistical Package for Social Sciences SPSS Inc Chicago IL USA Fisher Exact and Chi-square tests were used to determine the differences between proportions or relationships between categorical variables Paired Sample T-test was used to compare measurements at multiple different times in the same individuals The Students t-test was used when the data were normally distributed the Wilcoxon signed rank test was used for intragroup comparisons and the Mann Whitney U test was used for intergroup comparisons when the data were not normally distributed
Patients who had pain at the lateral epicondyle at least for four weeks detection of sensitivity by palpation on the lateral epicondyle and having positivity in at least two of the special tests Cozen test Maudsley test and Mills test were included in the study Physical therapy ESWT or local injections for lateral epicondylitis within the last 3 months the presence of cervical radiculopathy carpal tunnel syndrome other neuropathic diseases neurologic diseases medial epicondylitis systemic inflammatory diseases tenderness or swelling at the ipsilateral extremity and fibromyalgia have been excluded
Patients were randomized into three groups by a physiotherapist with sealed envelopes The researchers were blinded to the patients groups The same physiotherapy program was applied to all groups The physiotherapy program consisted of hot packs and transcutaneus electrical nerve stimulation TENS for 10 minutes and stretching and eccentric strengthening exercises were given to all groups All exercises were done under the supervision of the same physiotherapist
In addition to the ten-day of physiotherapy program in the first group one day for a week a total of 3 sessions of ESWT was applied at 18 bar 100 Hz 2000 beats Elmed Vibrolith Ortho
In the second group ten days of ultrasound applied at 15 wattcm2 continuous mode to the painful area for 5 minutes 5 days a week for two weeks Chattanooga Intelect Advanced
In the third group ten days of dexamethasone iontophoresis therapy was applied 10 days for 10 minutes 01 dexamethasone ophthalmic pomade was applied to the anodal electrode and placed on the lateral epicondyle and 01-02 milliamperecm2 galvanic current was applied in each session ES-522 ITO Physiotherapy and Rehabilitation
Evaluations were conducted at before treatment and one month after treatment in all groups by the same researchers who were blind in treatment groups
The clinical and demographic data of the patients were recorded Numerical Rating Scale NRS was used for the pain assessment The NRS is a subjective measure in which individuals rate their pain on an eleven-point numerical scale The scale is composed of 0 no pain at all to 10 worst imaginable pain It has been shown that a composite scoring system including best worse and current level of pain over the last 24 hours was sufficient to pick up changes in pain intensity with maximal reliabilityJensen et al 1999
The hand grip strength HGS was measured with a Jamar hydraulic hand dynamometer Saehan SH5001 in kilograms This instrument has a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the grip strength of the hand is registered in kilograms Hand and pinch strength were measured by hydraulic pinch gauge Saehan SH5005 This instrument has also a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the pinc strength of the hand is registered in kilograms Upper extremity disability levels were assessed with Quick Disabilities of the Arm Shoulder and Hand QuickDASH The Quick-DASH is an 11-item that measures upper extremity activity limitation and symptoms Items were scored from 1 indicating no functional limitation and no symptoms to 5 indicating functional inability and extreme symptoms The totalscore was computed by transforming the mean items score to a scale from 0 to 100 where 0 indicates the best upper extremity function and no symptoms Turkish version of the test was evaluated
Quality of life was measured by notthingham health profile NHP Scale 6 dimensions total It consists of 38 items Sub-dimensions Energy 3 items pain 8 items emotional status 9 items sleep 5 itemssocial isolation 5 items and physical activity 8 items Its range is 0-100is scored As the score increases health status gets worse The validity and reliability of the Turkish version of the test was evaluated
In the study power analysis performed by examining the related studies in the literature and the sample size required to obtain a significant result was calculated as totally 76 patients 26 patients in each group G-Power v3197 All data were analysed using the Windows 150 Statistical Package for Social Sciences SPSS Inc Chicago IL USA Fisher Exact and Chi-square tests were used to determine the differences between proportions or relationships between categorical variables Paired Sample T-test was used to compare measurements at multiple different times in the same individuals The Students t-test was used when the data were normally distributed the Wilcoxon signed rank test was used for intragroup comparisons and the Mann Whitney U test was used for intergroup comparisons when the data were not normally distributed
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