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Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Lateral Epicondylitis
Objectives: The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo.
Patients and Methods: Fifty one patients diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound, pulsed ultrasound and placebo groups by using closed envelop method. First group received continuous ultrasound treatment. Second group received pulsed ultrasound treatment in proportion as. Third group received of placebo treatment. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lateral Epicondylitis | Device: ultrasound | Not Applicable |
The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo.
Fifty one patients (33 women, 18 men) diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound (n=17), pulsed ultrasound (n=17) and placebo (n=17) groups by using closed envelop method. First group received 10 sessions of 1 W/cm2 and 1,5 MHz continuous ultrasound treatment. Second group received 10 sessions of 1 W/cm2 and 1,5 MHz pulsed ultrasound treatment in proportion as 1:4. Third group received 10 sessions of placebo treatment with the same device seemed to be working but without delivering any output. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 51 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | the patients and the physician was blind to the study |
| Primary Purpose: | Treatment |
| Official Title: | Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Patients With Lateral Epicondylitis : a Double Blind, Randomized and Placebo-controlled Study |
| Actual Study Start Date : | May 5, 2013 |
| Actual Primary Completion Date : | May 5, 2015 |
| Actual Study Completion Date : | November 5, 2018 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: continuous ultrasound
continuous ultrasound were applied to the patients
|
Device: ultrasound
therapeutical ultrasound were applied to the patients
|
|
Experimental: pulsed ultrasound
pulsed ultrasound were applied to the patients
|
Device: ultrasound
therapeutical ultrasound were applied to the patients
|
|
Experimental: placebo
placebo (sham) ultrasound were applied to the patients
|
Device: ultrasound
therapeutical ultrasound were applied to the patients
|
- measuring the thickness of common extensor tendon by ultrasound imaging. [ Time Frame: 2nd week ]the thickness of common extensor tendon by ultrasound imaging was measured at the beginning and at the end of the study
- Visual Analog Scale [ Time Frame: 6th week ]
- Duruoz's hand index [ Time Frame: 6th week ]
- Patient-Rated Tennis Elbow Evaluation (PRTEE) scales [ Time Frame: 6th week ]
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- aged between 18-70 years
- pain on the lateral side of the elbow for less than six months
- tenderness over the lateral epicondyle
- pain during extension of wrist and fingers
Exclusion Criteria:
- upper extremity and neck disorders
- other elbow pathologies
- presence of tendon rupture
- usage of non-steroidal anti inflammatory drugs
- joint limitations due to a previous radius/ulna fracture
- previous elbow surgery
- osteoporosis, malignancy, hemophilia, neurologic deficit(s) in the ipsilateral upper limb
- cognitive disfunction
| Study Director: | Fulya Bakılan | Eskisehir City Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||
| First Posted Date ICMJE | May 9, 2019 | ||||
| Last Update Posted Date | May 13, 2019 | ||||
| Actual Study Start Date ICMJE | May 5, 2013 | ||||
| Actual Primary Completion Date | May 5, 2015 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
measuring the thickness of common extensor tendon by ultrasound imaging. [ Time Frame: 2nd week ] the thickness of common extensor tendon by ultrasound imaging was measured at the beginning and at the end of the study
|
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| Original Primary Outcome Measures ICMJE |
measuring the thickness of common extensor tendon by ultrasound imaging. [ Time Frame: Day 10. ] the thickness of common extensor tendon by ultrasound imaging was measured at the beginning and at the end of the study
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Lateral Epicondylitis | ||||
| Official Title ICMJE | Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Patients With Lateral Epicondylitis : a Double Blind, Randomized and Placebo-controlled Study | ||||
| Brief Summary |
Objectives: The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo. Patients and Methods: Fifty one patients diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound, pulsed ultrasound and placebo groups by using closed envelop method. First group received continuous ultrasound treatment. Second group received pulsed ultrasound treatment in proportion as. Third group received of placebo treatment. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG). |
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| Detailed Description |
The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo. Fifty one patients (33 women, 18 men) diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound (n=17), pulsed ultrasound (n=17) and placebo (n=17) groups by using closed envelop method. First group received 10 sessions of 1 W/cm2 and 1,5 MHz continuous ultrasound treatment. Second group received 10 sessions of 1 W/cm2 and 1,5 MHz pulsed ultrasound treatment in proportion as 1:4. Third group received 10 sessions of placebo treatment with the same device seemed to be working but without delivering any output. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Masking Description: the patients and the physician was blind to the study Primary Purpose: Treatment
|
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| Condition ICMJE | Lateral Epicondylitis | ||||
| Intervention ICMJE | Device: ultrasound
therapeutical ultrasound were applied to the patients
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
51 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | November 5, 2018 | ||||
| Actual Primary Completion Date | May 5, 2015 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03944122 | ||||
| Other Study ID Numbers ICMJE | FTR | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Onur Armağan, Eskisehir Osmangazi University | ||||
| Study Sponsor ICMJE | Eskisehir Osmangazi University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Eskisehir Osmangazi University | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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