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

NCT02278289 | Completed Results DMC

• 1 other identifier: BuddhistTCGHTaipei
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire

  8 weeks

• Pain Scale

  8 weeks

• Difference of Monofilament Sensory Test (Before and After Treatment)

  8 weeks

• Difference in Palmar Pinch Power Test (Before and After Treatment)

  8 weeks

• Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment)

  8 weeks

Study Arms (2)

ultrasound therapy group

ACTIVE COMPARATOR

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

Device: ultrasound

paraffin therapy group

ACTIVE COMPARATOR

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

Procedure: paraffin therapy

Interventions

ultrasound DEVICE

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

ultrasound therapy group

paraffin therapy PROCEDURE

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 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead
• National Science and Technology Council, Taiwan: collaborator

Related Publications (1)

• Chang YW, Hsieh SF, Horng YS, Chen HL, Lee KC, Horng YS. Comparative effectiveness of ultrasound and paraffin therapy in patients with carpal tunnel syndrome: a randomized trial. BMC Musculoskelet Disord. 2014 Nov 26;15:399. doi: 10.1186/1471-2474-15-399.

  PMID: 25428566 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Yi-Shiung Horng
• Organization: Department of Physical Medicine and Rehabilitation, Taipei Tzuchi Hospital, Buddhist Tzuchi Medical Foundation, New Taipei City, Taiwan, ROC

d97841001@ntu.edu.tw

+886-2-66289779

Study Officials

• Yi Shiung Horng

  Taipei TzuChi hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 29, 2014
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 24, 2021
• Results First Posted: February 24, 2021

Record last verified: 2017-03