Carpal Tunnel Syndrome
Conditions
Keywords
Carpal tunnel syndrome,ultrasound,pulsed ultrasound
Brief summary
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
Detailed description
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.
Interventions
DEVICEultrasound
a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions
DEVICEpulsed 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
DEVICEplacebo 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
Sponsors
Eskisehir Osmangazi University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)
Exclusion criteria
* Secondary entrapment neuropathies * Cervical radiculopathy * Systemic diseases with increased risk of the carpal tunnel syndrome * Gained surgical relief of the syndrome * Treated with ultrasound for the syndrome * A history of steroid injections into the carpal tunnel and of physical therapy within the last 3 months * Patients with either thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electrophysiological examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Symptom Severity With Symptom Severity Scale | three weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain With Visual Analogue Scale | Three weeks | 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. |
| Change From Baseline in Functional Status With Functional Status Scale | Three weeks | 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. |
| Changes From Baseline Nervus Medianus Motor Conduction Velocity | Three weeks | Post treatment comparison of Median motor nerve conduction velocity between three groups |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 16 |
| 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 | 15 |
| Total | 46 |
Baseline characteristics
| Characteristic | Ultrasound | Pulsed Ultrasound | Placebo Ultrasound | Total |
|---|---|---|---|---|
| Age, Continuous age mean | 43.31 years STANDARD_DEVIATION 2.79 | 45.20 years STANDARD_DEVIATION 2.98 | 44.53 years STANDARD_DEVIATION 2.38 | 44.34 years STANDARD_DEVIATION 2.71 |
| Region of Enrollment Turkey | 15 participants | 16 participants | 15 participants | 46 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 15 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 | 0 / 15 |
Outcome results
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.
Time frame: three weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound | Change From Baseline in Symptom Severity With Symptom Severity Scale | 23.06 units on a scale | Standard Deviation 8.13 |
| Pulsed Ultrasound | Change From Baseline in Symptom Severity With Symptom Severity Scale | 22.06 units on a scale | Standard Deviation 8.73 |
| Placebo Ultrasound | Change From Baseline in Symptom Severity With Symptom Severity Scale | 19.66 units on a scale | Standard Deviation 4.6 |
p-value: 0.442ANOVA
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.
Time frame: Three weeks
Population: ultrasound group has 15 patients, pulsed us group has 16 patients, placebo us has 15 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound | Change From Baseline in Functional Status With Functional Status Scale | 18.8 score | Standard Deviation 7.34 |
| Pulsed Ultrasound | Change From Baseline in Functional Status With Functional Status Scale | 19.31 score | Standard Deviation 9.42 |
| Placebo Ultrasound | Change From Baseline in Functional Status With Functional Status Scale | 14.2 score | Standard Deviation 4.52 |
p-value: 0.125ANOVA
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.
Time frame: Three weeks
Population: ultrasound group has 15, pulsed us group has 16, placebo us group has 15 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound | Change From Baseline in Pain With Visual Analogue Scale | 4.40 score | Standard Deviation 2.32 |
| Pulsed Ultrasound | Change From Baseline in Pain With Visual Analogue Scale | 2.68 score | Standard Deviation 1.92 |
| Placebo Ultrasound | Change From Baseline in Pain With Visual Analogue Scale | 3.53 score | Standard Deviation 1.95 |
p-value: 0.083ANOVA
Secondary
Changes From Baseline Nervus Medianus Motor Conduction Velocity
Post treatment comparison of Median motor nerve conduction velocity between three groups
Time frame: Three weeks
Population: ultrasound group has 15 patients, pulsed us group has 16 patients, placebo us group has 15 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound | Changes From Baseline Nervus Medianus Motor Conduction Velocity | 54.26 meter/seconds | Standard Deviation 4.29 |
| Pulsed Ultrasound | Changes From Baseline Nervus Medianus Motor Conduction Velocity | 55.68 meter/seconds | Standard Deviation 5.24 |
| Placebo Ultrasound | Changes From Baseline Nervus Medianus Motor Conduction Velocity | 57.91 meter/seconds | Standard Deviation 5.44 |
p-value: 0.146ANOVA