Trial Outcomes & Findings for Comparative Effectiveness of Ultrasound and Paraffin Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Trial (NCT NCT02278289)

NCT ID: NCT02278289

Last Updated: 2021-02-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2021-02-24

Participant Flow

Participant milestones

Measure	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.	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
Overall Study STARTED	30	30
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of Ultrasound and Paraffin Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Trial

Baseline characteristics by cohort

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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	Total n=47 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 11.2 • n=5 Participants	51.9 years STANDARD_DEVIATION 8.8 • n=7 Participants	50.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex/Gender, Customized Female	22 participants n=5 Participants	20 participants n=7 Participants	42 participants n=5 Participants
Sex/Gender, Customized Male	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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
Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire	1.6 units on a scale Standard Deviation 0.7	1.8 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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
Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire	2.1 units on a scale Standard Deviation 0.8	1.9 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 8 weeks

The pain VAS is a continuous scale comprised 10 centimeters (100 mm) in length. 0 indicate no pain, 100 indicate maximum pain.

Outcome measures

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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
Pain Scale	54.2 units on a scale Standard Deviation 22.6	50.7 units on a scale Standard Deviation 22.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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
Difference of Monofilament Sensory Test (Before and After Treatment)	1.2 units on a scale Standard Deviation 3.3	1.2 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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
Difference in Palmar Pinch Power Test (Before and After Treatment)	0.5 kilograms Standard Deviation 1.4	0.4 kilograms Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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
Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment)	0.03 milliseconds Standard Deviation 1.1	-0.2 milliseconds Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ultrasound Therapy Group n=24 Participants 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.	Paraffin Therapy Group n=23 Participants 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
Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment)	-0.03 milliseconds Standard Deviation 0.6	-0.3 milliseconds Standard Deviation 0.6

Adverse Events

Ultrasound Therapy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paraffin Therapy Group

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. Yi-Shiung Horng

Department of Physical Medicine and Rehabilitation, Taipei Tzuchi Hospital, Buddhist Tzuchi Medical Foundation, New Taipei City, Taiwan, ROC

Phone: +886-2-66289779

Email: d97841001@ntu.edu.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place