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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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The purpose of this study is to compare the efficacy of combining a wrist orthosis with either ultrasound therapy or paraffin bath therapy in treating carpal tunnel syndrome patients.
The purpose of this exploratory study is to compare the combination of a wrist orthosis with either ultrasound therapy or paraffin bath therapy in the treatment of carpal tunnel syndrome patients. We hypothesized that ultrasound therapy might be more effective than paraffin therapy because it provides both thermal and nonthermal effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound therapy group | Active Comparator | Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. |
|
| paraffin therapy group | Active Comparator | Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound | Device | Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire | All of the answers were scored from 1 to 5 according to the patient's clinical condition, such that 1 indicated no symptoms, and 5 indicated the most severe symptoms. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire | All of the answers were scored from 1 to 5 according to the patient's clinical condition, such that 1 indicated no symptoms, and 5 indicated the most severe symptoms. | 8 weeks |
| Pain Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Shiung Horng | Taipei TzuChi hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25428566 | Derived | Chang YW, Hsieh SF, Horng YS, Chen HL, Lee KC, Horng YS. Comparative effectiveness of ultrasound and paraffin therapy in patients with carpal tunnel syndrome: a randomized trial. BMC Musculoskelet Disord. 2014 Nov 26;15:399. doi: 10.1186/1471-2474-15-399. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Therapy Group | Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. ultrasound: Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. |
| FG001 | Paraffin Therapy Group | Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C paraffin therapy: Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Therapy Group | Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. ultrasound: Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. |
| BG001 |
| 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 | Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire | All of the answers were scored from 1 to 5 according to the patient's clinical condition, such that 1 indicated no symptoms, and 5 indicated the most severe symptoms. | Posted | Mean | Standard Deviation | units on a scale | 8 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 Therapy Group | Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. ultrasound: Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yi-Shiung Horng | Department of Physical Medicine and Rehabilitation, Taipei Tzuchi Hospital, Buddhist Tzuchi Medical Foundation, New Taipei City, Taiwan, ROC | +886-2-66289779 | 64515 | d97841001@ntu.edu.tw |
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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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| paraffin therapy | Procedure | Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C |
|
The pain VAS is a continuous scale comprised 10 centimeters (100 mm) in length. 0 indicate no pain, 100 indicate maximum pain. |
| 8 weeks |
| Difference of Monofilament Sensory Test (Before and After Treatment) | The Semmes-Weinstein monofilament sensory test was measured by applying force-calibrated nylon filament to the fingertips with the wrist in a neutral supine position A weighted score from 1 to 5 was acquired according to each filament's calculated force . We recorded the scores from seven sample areas in each hand and summed the scores to analyze as a continuous variable.Higher score indicate decreased finger tip sensation with increased disesase severity.Total score range:7 -35. | 8 weeks |
| Difference in Palmar Pinch Power Test (Before and After Treatment) | Palmar pinch strength was measured by pressing the thumb and the index finger tip against a standard dynamometer. This procedure was repeated 3 times measuring in kilograms, and a mean score was obtained. Higher score indicate better pinching strength, which indicate less disease severity. Score range: minimum :0 kilogram | 8 weeks |
| Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment) | A standard distance (14 centimeter) was maintained between the stimulator and recording electrodes for the sensory nerve conduction studies. Increased distal latency indicate delay of nerve conduction, which imply poor disease progress. | 8 weeks |
| Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment) | Median motor nerve conduction and distal motor latency were measured by placing a stimulating electrode at the wrist and a recording electrode on the abductor pollicis brevis muscle 8 centimeter from the stimulus electrode. Increased distal latency indicate delay of nerve conduction, which imply poor disease progress. | 8 weeks |
| Paraffin Therapy Group |
Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C paraffin therapy: Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
|
|
| Secondary | Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire | All of the answers were scored from 1 to 5 according to the patient's clinical condition, such that 1 indicated no symptoms, and 5 indicated the most severe symptoms. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Pain Scale | The pain VAS is a continuous scale comprised 10 centimeters (100 mm) in length. 0 indicate no pain, 100 indicate maximum pain. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Difference of Monofilament Sensory Test (Before and After Treatment) | The Semmes-Weinstein monofilament sensory test was measured by applying force-calibrated nylon filament to the fingertips with the wrist in a neutral supine position A weighted score from 1 to 5 was acquired according to each filament's calculated force . We recorded the scores from seven sample areas in each hand and summed the scores to analyze as a continuous variable.Higher score indicate decreased finger tip sensation with increased disesase severity.Total score range:7 -35. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Difference in Palmar Pinch Power Test (Before and After Treatment) | Palmar pinch strength was measured by pressing the thumb and the index finger tip against a standard dynamometer. This procedure was repeated 3 times measuring in kilograms, and a mean score was obtained. Higher score indicate better pinching strength, which indicate less disease severity. Score range: minimum :0 kilogram | Posted | Mean | Standard Deviation | kilograms | 8 weeks |
|
|
|
| Secondary | Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment) | A standard distance (14 centimeter) was maintained between the stimulator and recording electrodes for the sensory nerve conduction studies. Increased distal latency indicate delay of nerve conduction, which imply poor disease progress. | Posted | Mean | Standard Deviation | milliseconds | 8 weeks |
|
|
|
| Secondary | Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment) | Median motor nerve conduction and distal motor latency were measured by placing a stimulating electrode at the wrist and a recording electrode on the abductor pollicis brevis muscle 8 centimeter from the stimulus electrode. Increased distal latency indicate delay of nerve conduction, which imply poor disease progress. | Posted | Mean | Standard Deviation | milliseconds | 8 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Paraffin Therapy Group | Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C paraffin therapy: Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C | 0 | 23 | 0 | 23 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |