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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278289
• Other study ID #: BuddhistTCGHTaipei
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• ultrasound
Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	National Science Council, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks
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.	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.	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.	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	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.	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.	8 weeks