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NCT Number: NCT02278289

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

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

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2014
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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