Carpal Tunnel SyndromeNCT04499014
Ultrasound and Phonophoresis in Carpal Tunnel Syndrome
A study testing ultrasound in people with Carpal Tunnel Syndrome, run by Eskisehir City Hospital.
Trial summary
In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic carpal tunnel syndrome. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2014to 15 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)
Who cannot join
- The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic diseases, acute trauma, pregnancy etc.)
- cervical radiculopathy
- etiologic factors which predispose to or polyneuropathy
- reinnervation or fibrillation potentials in their abductor pollicis brevis muscles
- physical or medical therapy within 3 months for CTS and steroid injection applied
- experience CTS median nerve trauma and CTS surgery
Show all 9Show fewer
- serious thenar atrophy and anesthesia
- contraindication in steroid treatment (steroid allergies, hypertension etc.)
- contraindication in ultrasonic therapy (bleeding disorders, acute inflammation of the joints, acute infections, cancer and precancerous lesions, arteriovenous circulatory disorders etc.)
About this study
Official title: Evaluation of the Effects of Steroid Phonophoresis and Therapeutic Ultrasound in Carpal Tunnel Syndrome: A Randomized Placebo - Controlled Trial
In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic carpal tunnel syndrome.
Read the detailed description
Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided three groups. The first group was ultrasound group, the second group was PH group and the third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1% dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm² ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston Symptom Severity Scale, Functional Capacity Scale, grip strength and electroneurophysiological evaluations were compared before the treatment, after the treatment and three months later.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- ultrasound
- Keywords
- carpal tunnel syndrome, steroid phonophoresis, ultrasound
- 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
Also called phonophoresis, placebo ultrasound
5 days a week, a total of 10 sessions
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Experimental | ultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions Receives: Device: ultrasound |
| phonophoresis | Experimental | an intensity of 1 W/cm2 and a frequency of 1 MHz and phonophoresis with 0.1% dexamethasone pomade,5 days a week, a total of 10 sessions Receives: Device: ultrasound |
| placebo ultrasound | Placebo comparator | same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Change from baseline in pain with Visual Analogue Scale:Patients were asked to express the pain felt by them using 0-10 scales, 0 no pain and 10 the most severe pain faced throughout their life.
Measured: three month
Boston Symptom Severity Scale
Change from baseline in symptom severity with Boston Symptom Severity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and the score was determined and high scores were interpreted as increased symptom severity
Measured: three month
Boston Functional Capacity Scale
Change from baseline in functional status with Boston Functional Capacity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and average score was determined and high scores were interpreted as functionality deformation in the hands
Measured: three month
grip strength
Change from baseline in strength with grip strength:To assess the grip strength, baseline hydraulic hand dynamometer was used. 3 measurements were made for each patient and the average of them was calculated
Measured: three month
electroneurophysiological evaluations
Change from baseline electroneurophysiological measurement:The median nerve motor conduction velocity(m/s) , the median nerve motor distal latency(ms), 2nd finger - palm median nerve sensory distal latency(ms), 2nd finger - palm median nerve sensory conduction velocity(m/s), median sensory nerve conduction velocity(m/s) and median nerve sensory distal latency between the wrist and palm(ms)
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start14 Mar 2014
- Primary completion1 Oct 2015
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Bakılan, Eskisehir City Hospital
- Investigators
- Burcu Ortanca, Principal investigator, Eskişehir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499014
- Sponsor's protocol ID
- 1234567
- Status last verified
- Jan 2016
- First submitted
- 28 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Steroid Phonophoresis and Therapeutic Ultrasound in Carpal Tunnel Syndrome: A Randomized Placebo - Controlled Trial
- ClinicalTrials.gov ID
- NCT04499014
- Acronym / sponsor ID
- 1234567
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, steroid phonophoresis, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Eskisehir City HospitalUniversity, hospital or other
- Study start
- 14 Mar 2014 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic carpal tunnel syndrome.
Detailed description
Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided three groups. The first group was ultrasound group, the second group was PH group and the third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1% dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm² ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston Symptom Severity Scale, Functional Capacity Scale, grip strength and electroneurophysiological evaluations were compared before the treatment, after the treatment and three months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ultrasound | Experimental | Device: ultrasoundultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions |
| phonophoresis | Experimental | Device: ultrasoundan intensity of 1 W/cm2 and a frequency of 1 MHz and phonophoresis with 0.1% dexamethasone pomade,5 days a week, a total of 10 sessions |
| placebo ultrasound | Placebo comparator | Device: ultrasoundsame ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)
Key exclusion criteria (9 listed)
- The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic diseases, acute trauma, pregnancy etc.)
- cervical radiculopathy
- etiologic factors which predispose to or polyneuropathy
- reinnervation or fibrillation potentials in their abductor pollicis brevis muscles
- physical or medical therapy within 3 months for CTS and steroid injection applied
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 |
|---|---|---|
| ultrasoundAlso: phonophoresis, placebo ultrasound5 days a week, a total of 10 sessions | Device | phonophoresis, placebo ultrasound, ultrasound |
Primary outcome
Visual Analogue Scale
Time frame: three month
Change from baseline in pain with Visual Analogue Scale:Patients were asked to express the pain felt by them using 0-10 scales, 0 no pain and 10 the most severe pain faced throughout their life.
Boston Symptom Severity Scale
Time frame: three month
Change from baseline in symptom severity with Boston Symptom Severity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and the score was determined and high scores were interpreted as increased symptom severity
Boston Functional Capacity Scale
Time frame: three month
Change from baseline in functional status with Boston Functional Capacity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and average score was determined and high scores were interpreted as functionality deformation in the hands
grip strength
Time frame: three month
Change from baseline in strength with grip strength:To assess the grip strength, baseline hydraulic hand dynamometer was used. 3 measurements were made for each patient and the average of them was calculated
electroneurophysiological evaluations
Time frame: three month
Change from baseline electroneurophysiological measurement:The median nerve motor conduction velocity(m/s) , the median nerve motor distal latency(ms), 2nd finger - palm median nerve sensory distal latency(ms), 2nd finger - palm median nerve sensory conduction velocity(m/s), median sensory nerve conduction velocity(m/s) and median nerve sensory distal latency between the wrist and palm(ms)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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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.
Burcu Ortanca principal investigator
Eskişehir City Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Carpal Tunnel Syndrome, run by Eskisehir City Hospital.
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 9 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 5 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale (time frame: three month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2020.