Carpal Tunnel SyndromeNCT02278289
Comparative Effectiveness of Ultrasound and Paraffin Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Trial
A study testing ultrasound and paraffin therapy in people with Carpal Tunnel Syndrome, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- ultrasound and paraffin therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (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.
About this study
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- ultrasound, paraffin therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.
paraffin therapyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: paraffin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (6)
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.
Measured: 8 weeks
Pain Scale
The pain VAS is a continuous scale comprised 10 centimeters (100 mm) in length. 0 indicate no pain, 100 indicate maximum pain.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yi Shiung Horng, Principal investigator, Taipei TzuChi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278289
- Sponsor's protocol ID
- BuddhistTCGHTaipei
- Status last verified
- Mar 2017
- First submitted
- 13 Oct 2014
- Last updated
- 24 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25428566
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Ultrasound and Paraffin Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02278289
- Acronym / sponsor ID
- BuddhistTCGHTaipei
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound therapy group | Active comparator | Device: ultrasoundPatients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. |
| paraffin therapy group | Active comparator | Procedure: paraffin therapyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundPatients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks. | Device | ultrasound therapy group |
| paraffin therapyPatients 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 or surgery | paraffin therapy group |
Primary outcome
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.
6 secondary outcomes
Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire
Time frame: 8 weeks
Pain Scale
Time frame: 8 weeks
Difference of Monofilament Sensory Test (Before and After Treatment)
Time frame: 8 weeks
Difference in Palmar Pinch Power Test (Before and After Treatment)
Time frame: 8 weeks
Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment)
Time frame: 8 weeks
Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25428566Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Shiung Horng principal investigator
Taipei TzuChi hospital
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and paraffin therapy in people with Carpal Tunnel Syndrome, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.