Carpal Tunnel SyndromeNCT02054247
Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome
A study testing ultrasound and pulsed ultrasound in people with Carpal Tunnel Syndrome, run by Eskisehir Osmangazi University.
Trial summary
The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- ultrasound and pulsed ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jun 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, 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
- Secondary entrapment neuropathies
- Cervical radiculopathy
- Systemic diseases with increased risk of the carpal tunnel syndrome
- Gained surgical relief of the syndrome
- Treated with ultrasound for the syndrome
- A history of steroid injections into the carpal tunnel and of physical therapy within the last 3 months
- Patients with either thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electrophysiological examination
About this study
Official title: The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial
The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome
Read the detailed description
The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- ultrasound, pulsed ultrasound, placebo ultrasound
- Keywords
- Carpal tunnel syndrome,ultrasound,pulsed 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
a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions
pulsed ultrasoundDevice
a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions
placebo ultrasoundDevice
same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Experimental | ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 Receives: Device: ultrasound |
| pulsed ultrasound | Experimental | pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4 Receives: Device: pulsed ultrasound |
| placebo ultrasound | Placebo comparator | placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output Receives: Device: placebo ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Symptom Severity With Symptom Severity Scale
Post treatment comparison of Symptom Severity Scale between three groups minimum score is 11, maximum score is 55. The clinic of patient worses when the score increases.
Measured: three weeks
Secondary outcomes (3)
Change From Baseline in Pain With Visual Analogue Scale
Post treatment comparison of Visual Analogue Scale between three groups min score is 0, maximum score is 10. The clinic of patient worses when the score increases.
Measured: Three weeks
Change From Baseline in Functional Status With Functional Status Scale
Post treatment comparison of Functional Status Scale between three groups min score is 8, maximum score is 40. The clinic of patient worses when the score increases.
Measured: Three weeks
Changes From Baseline Nervus Medianus Motor Conduction Velocity
Post treatment comparison of Median motor nerve conduction velocity between three groups
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Armağan, Eskisehir Osmangazi University
- Investigators
- Onur ARMAGAN, ass. prof., Study director, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054247
- Sponsor's protocol ID
- clinics-2013-0627
- Status last verified
- Nov 2023
- First submitted
- 27 Jan 2014
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Armagan O, Bakilan F, Ozgen M, Mehmetoglu O, Oner S. Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial. Clinics (Sao Paulo). 2014 Aug;69(8):524-8. doi: 10.6061/clinics/2014(08)04.
PubMed 25141110
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial
- ClinicalTrials.gov ID
- NCT02054247
- Acronym / sponsor ID
- clinics-2013-0627
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome,ultrasound,pulsed ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome
Detailed description
The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ultrasound | Experimental | Device: ultrasoundultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 |
| pulsed ultrasound | Experimental | Device: pulsed ultrasoundpulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4 |
| placebo ultrasound | Placebo comparator | Device: placebo ultrasoundplacebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 (7 listed)
- Secondary entrapment neuropathies
- Cervical radiculopathy
- Systemic diseases with increased risk of the carpal tunnel syndrome
- Gained surgical relief of the syndrome
- Treated with ultrasound for the syndrome
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 |
|---|---|---|
| ultrasounda frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions | Device | ultrasound |
| pulsed ultrasounda frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions | Device | pulsed ultrasound |
| placebo ultrasoundsame ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions | Device | placebo ultrasound |
Primary outcome
Change From Baseline in Symptom Severity With Symptom Severity Scale
Time frame: three weeks
Post treatment comparison of Symptom Severity Scale between three groups minimum score is 11, maximum score is 55. The clinic of patient worses when the score increases.
3 secondary outcomes
Change From Baseline in Pain With Visual Analogue Scale
Time frame: Three weeks
Change From Baseline in Functional Status With Functional Status Scale
Time frame: Three weeks
Changes From Baseline Nervus Medianus Motor Conduction Velocity
Time frame: Three weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25141110Armagan O, Bakilan F, Ozgen M, Mehmetoglu O, Oner S. Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial. Clinics (Sao Paulo). 2014 Aug;69(8):524-8. doi: 10.6061/clinics/2014(08)04.
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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.
Onur ARMAGAN, ass. prof. study director
Eskisehir Osmangazi University
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and pulsed ultrasound in people with Carpal Tunnel Syndrome, run by Eskisehir Osmangazi University.
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 7 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 7 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2023). 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?
Change From Baseline in Symptom Severity With Symptom Severity Scale (time frame: three 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 NCT02054247, 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 7 Nov 2023.