Carpal Tunnel Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEultrasound
Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.
PROCEDUREparaffin 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
Sponsors
National Science and Technology Council, Taiwan
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients to have subjective symptoms (such as pain and/or numbness in the median nerve distribution of the digits or nocturnal pain). Furthermore, patients were required to have either a positive Phalen's sign or a positive Tinel's sign along with electrophysiological evidence of carpal tunnel syndrome.
Exclusion criteria
* (1) age younger than 18 years old; (2) underlying medical disorders, such as diabetes mellitus, renal failure, autoimmune disease or hypothyroidism; and (3) pregnancy, previous wrist trauma or surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale | 8 weeks | The pain VAS is a continuous scale comprised 10 centimeters (100 mm) in length. 0 indicate no pain, 100 indicate maximum pain. |
| Difference of Monofilament Sensory Test (Before and After Treatment) | 8 weeks | 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. |
| Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire | 8 weeks | 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. |
| Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment) | 8 weeks | 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. |
| Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment) | 8 weeks | 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. |
| Difference in Palmar Pinch Power Test (Before and After Treatment) | 8 weeks | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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 | 23 |
| Total | 47 |
Baseline characteristics
| Characteristic | Ultrasound Therapy Group | Paraffin Therapy Group | Total |
|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 11.2 | 51.9 years STANDARD_DEVIATION 8.8 | 50.4 years STANDARD_DEVIATION 10.1 |
| Sex/Gender, Customized Female | 22 participants | 20 participants | 42 participants |
| Sex/Gender, Customized Male | 2 participants | 3 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Therapy Group | Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire | 1.6 units on a scale | Standard Deviation 0.7 |
| Paraffin Therapy Group | Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire | 1.8 units on a scale | Standard Deviation 0.9 |
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
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Therapy Group | Difference in Palmar Pinch Power Test (Before and After Treatment) | 0.5 kilograms | Standard Deviation 1.4 |
| Paraffin Therapy Group | Difference in Palmar Pinch Power Test (Before and After Treatment) | 0.4 kilograms | Standard Deviation 1.8 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Therapy Group | Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment) | -0.03 milliseconds | Standard Deviation 0.6 |
| Paraffin Therapy Group | Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment) | -0.3 milliseconds | Standard Deviation 0.6 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Therapy Group | Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment) | 0.03 milliseconds | Standard Deviation 1.1 |
| Paraffin Therapy Group | Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment) | -0.2 milliseconds | Standard Deviation 0.9 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Therapy Group | Difference of Monofilament Sensory Test (Before and After Treatment) | 1.2 units on a scale | Standard Deviation 3.3 |
| Paraffin Therapy Group | Difference of Monofilament Sensory Test (Before and After Treatment) | 1.2 units on a scale | Standard Deviation 3.5 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Therapy Group | Pain Scale | 54.2 units on a scale | Standard Deviation 22.6 |
| Paraffin Therapy Group | Pain Scale | 50.7 units on a scale | Standard Deviation 22.7 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Therapy Group | Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire | 2.1 units on a scale | Standard Deviation 0.8 |
| Paraffin Therapy Group | Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire | 1.9 units on a scale | Standard Deviation 0.7 |