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The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome
The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound | Experimental | ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 |
|
| pulsed ultrasound | Experimental | pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4 |
|
| placebo ultrasound | Placebo Comparator | placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound | Device | a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Symptom Severity With Symptom Severity Scale | Post treatment comparison of Symptom Severity Scale between three groups minimum score is 11, maximum score is 55. The clinic of patient worses when the score increases. | three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain With Visual Analogue Scale | Post treatment comparison of Visual Analogue Scale between three groups min score is 0, maximum score is 10. The clinic of patient worses when the score increases. | Three weeks |
| Change From Baseline in Functional Status With Functional Status Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Onur ARMAGAN, ass. prof. | Eskisehir Osmangazi University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25141110 | Derived | Armagan O, Bakilan F, Ozgen M, Mehmetoglu O, Oner S. Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial. Clinics (Sao Paulo). 2014 Aug;69(8):524-8. doi: 10.6061/clinics/2014(08)04. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound | ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 ultrasound: a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions |
| FG001 | Pulsed Ultrasound | pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4 pulsed ultrasound: a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions |
| FG002 | Placebo Ultrasound | placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output placebo ultrasound: same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound | ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 ultrasound: a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions |
| BG001 | Pulsed Ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Symptom Severity With Symptom Severity Scale | Post treatment comparison of Symptom Severity Scale between three groups minimum score is 11, maximum score is 55. The clinic of patient worses when the score increases. | Posted | Mean | Standard Deviation | units on a scale | three weeks |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound | ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 ultrasound: a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Onur Armagan | Eskisehir Osmangazi University | 00902222392979 | dronurarmagan@hotmail.com |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| pulsed ultrasound | Device | a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions |
|
| placebo ultrasound | Device | same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions |
|
Post treatment comparison of Functional Status Scale between three groups min score is 8, maximum score is 40. The clinic of patient worses when the score increases. |
| Three weeks |
| Changes From Baseline Nervus Medianus Motor Conduction Velocity | Post treatment comparison of Median motor nerve conduction velocity between three groups | Three weeks |
pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4
pulsed ultrasound: a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions
| BG002 | Placebo Ultrasound | placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output placebo ultrasound: same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo Ultrasound | placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output placebo ultrasound: same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions |
|
|
|
| Secondary | Change From Baseline in Pain With Visual Analogue Scale | Post treatment comparison of Visual Analogue Scale between three groups min score is 0, maximum score is 10. The clinic of patient worses when the score increases. | ultrasound group has 15, pulsed us group has 16, placebo us group has 15 patients | Posted | Mean | Standard Deviation | score | Three weeks |
|
|
|
|
| Secondary | Change From Baseline in Functional Status With Functional Status Scale | Post treatment comparison of Functional Status Scale between three groups min score is 8, maximum score is 40. The clinic of patient worses when the score increases. | ultrasound group has 15 patients, pulsed us group has 16 patients, placebo us has 15 patients. | Posted | Mean | Standard Deviation | score | Three weeks |
|
|
|
|
| Secondary | Changes From Baseline Nervus Medianus Motor Conduction Velocity | Post treatment comparison of Median motor nerve conduction velocity between three groups | ultrasound group has 15 patients, pulsed us group has 16 patients, placebo us group has 15 patients. | Posted | Mean | Standard Deviation | meter/seconds | Three weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Pulsed Ultrasound | pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4 pulsed ultrasound: a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Placebo Ultrasound | placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output placebo ultrasound: same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions | 0 | 15 | 0 | 15 | 0 | 15 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |