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

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ClinicalTrials.gov Identifier: NCT02278289
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: ultrasound Procedure: paraffin therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Ultrasound and Paraffin Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Trial
Study Start Date : January 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Active Comparator: 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.
Device: ultrasound
Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.

Active Comparator: 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
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




Primary Outcome Measures :
  1. Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire [ Time Frame: 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.


Secondary Outcome Measures :
  1. Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire [ Time Frame: 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.

  2. Pain Scale [ Time Frame: 8 weeks ]
    The pain VAS is a continuous scale comprised 10 centimeters (100 mm) in length. 0 indicate no pain, 100 indicate maximum pain.

  3. Difference of Monofilament Sensory Test (Before and After Treatment) [ Time Frame: 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.

  4. Difference in Palmar Pinch Power Test (Before and After Treatment) [ Time Frame: 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

  5. Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment) [ Time Frame: 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.

  6. Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278289


Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
National Science Council, Taiwan
Investigators
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Principal Investigator: Yi Shiung Horng Taipei TzuChi hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT02278289    
Other Study ID Numbers: BuddhistTCGHTaipei
First Posted: October 29, 2014    Key Record Dates
Results First Posted: February 24, 2021
Last Update Posted: February 24, 2021
Last Verified: March 2017
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries