Trial Outcomes & Findings for Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome (NCT NCT02054247)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

three weeks

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	15	16	15
Overall Study COMPLETED	15	16	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound n=15 Participants 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	Pulsed Ultrasound n=16 Participants 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	Placebo Ultrasound n=15 Participants 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	Total n=46 Participants Total of all reporting groups
Age, Continuous age mean	43.31 years STANDARD_DEVIATION 2.79 • n=5 Participants	45.20 years STANDARD_DEVIATION 2.98 • n=7 Participants	44.53 years STANDARD_DEVIATION 2.38 • n=5 Participants	44.34 years STANDARD_DEVIATION 2.71 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	46 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Turkey	15 participants n=5 Participants	16 participants n=7 Participants	15 participants n=5 Participants	46 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrasound n=15 Participants 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	Pulsed Ultrasound n=16 Participants 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	Placebo Ultrasound n=15 Participants 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
Change From Baseline in Symptom Severity With Symptom Severity Scale	23.06 units on a scale Standard Deviation 8.13	22.06 units on a scale Standard Deviation 8.73	19.66 units on a scale Standard Deviation 4.60

SECONDARY outcome

Timeframe: Three weeks

Population: ultrasound group has 15, pulsed us group has 16, placebo us group has 15 patients

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.

Outcome measures

Outcome measures
Measure	Ultrasound n=15 Participants 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	Pulsed Ultrasound n=16 Participants 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	Placebo Ultrasound n=15 Participants 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
Change From Baseline in Pain With Visual Analogue Scale	4.40 score Standard Deviation 2.32	2.68 score Standard Deviation 1.92	3.53 score Standard Deviation 1.95

SECONDARY outcome

Timeframe: Three weeks

Population: ultrasound group has 15 patients, pulsed us group has 16 patients, placebo us has 15 patients.

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.

Outcome measures

Outcome measures
Measure	Ultrasound n=15 Participants 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	Pulsed Ultrasound n=16 Participants 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	Placebo Ultrasound n=15 Participants 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
Change From Baseline in Functional Status With Functional Status Scale	18.8 score Standard Deviation 7.34	19.31 score Standard Deviation 9.42	14.2 score Standard Deviation 4.52

SECONDARY outcome

Timeframe: Three weeks

Population: ultrasound group has 15 patients, pulsed us group has 16 patients, placebo us group has 15 patients.

Post treatment comparison of Median motor nerve conduction velocity between three groups

Outcome measures

Outcome measures
Measure	Ultrasound n=15 Participants 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	Pulsed Ultrasound n=16 Participants 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	Placebo Ultrasound n=15 Participants 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
Changes From Baseline Nervus Medianus Motor Conduction Velocity	54.26 meter/seconds Standard Deviation 4.29	55.68 meter/seconds Standard Deviation 5.24	57.91 meter/seconds Standard Deviation 5.44

Adverse Events

Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pulsed Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Onur Armagan

Eskisehir Osmangazi University

Phone: 00902222392979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place