Carpal Tunnel SyndromeNCT06658886
Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the efficacy of paraffin therapy, a physical therapy modality, and ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome, the most common entrapment neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2024to 25 Feb 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Adult, Older adult
Study population: Mild and moderate carpal tunnel syndrome
Who may be able to join
- Patients aged 18-65.
- Diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies.
- Received either ultrasound-guided corticosteroid injection or paraffin therapy.
- Symptoms persisting for at least 3 months.
Who cannot join
- Diagnosis of other conditions causing neuropathic symptoms (e.g., polyneuropathy, brachial plexopathy, thoracic outlet syndrome).
- History of previous injection or surgery for carpal tunnel syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
Büşra Şirin, 02124443322, bsrn080@gmail.com
About this study
The aim of this study is to compare the efficacy of paraffin therapy, a physical therapy modality, and ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome, the most common entrapment neuropathy. By doing so, the study will evaluate the effectiveness and feasibility of these two alternative, low-side-effect treatments for managing this frequently encountered condition.
Read the detailed description
A total of 46 patients, aged 18-65, diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies, will be included in the study.Pain levels will be assessed using the Visual Analog Scale (VAS), and functional impairment will be measured with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological evaluations will be performed by a neurology specialist at the 1st and 3rd month follow-ups outside of working hours and without being billed to the Social Security Institution (SGK). VAS, BCTQ scores, and electrophysiological parameters will be evaluated at baseline, and at the 4th and 12th-week follow-ups post-treatment. Electrophysiological measurements will include median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) amplitudes.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- No intervention
- 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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Paraffin treatment group | Patients with carpal tunnel syndrome who have received paraffin therapy Receives: Other: No intervention | |
| Injection group | Patients with carpal tunnel syndrome who have applied ultrasound-guided steroid injection Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS):
The VAS will be used to measure pain intensity. Patients will mark their pain level on a 10 cm scale, where 0 represents "no pain" and 10 represents the "worst imaginable pain." This will be evaluated at baseline, and at the 4th and 12th weeks post-treatment.
Measured: 0 day, 4th week and 12th week
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity Scale (BCTQ-SSS)
The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.
Measured: 0 day, 4th week and 12th week
Boston Carpal Tunnel Syndrome Questionnaire Functional Status Scale (BCTQ-FSS)
The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.
Measured: 0 day, 4th week and 12th week
Secondary outcomes (6)
Median nerve distal motor latency
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Median nerve distal sensory latency
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Sensory nerve conduction velocity
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Motor nerve conduction velocity
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Sensory nerve action potential amplitude
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Motor nerve action potential amplitude
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start10 Nov 2024
- Primary completion25 Feb 2025 (estimated)
- Study completion25 Feb 2025 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658886
- Sponsor's protocol ID
- BeylikduzuStateH9
- Status last verified
- Dec 2024
- First submitted
- 22 Oct 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06658886
- Acronym / sponsor ID
- BeylikduzuStateH9
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 25 Feb 2025 (estimated)
- First posted
- 26 Oct 2024 (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.
The aim of this study is to compare the efficacy of paraffin therapy, a physical therapy modality, and ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome, the most common entrapment neuropathy. By doing so, the study will evaluate the effectiveness and feasibility of these two alternative, low-side-effect treatments for managing this frequently encountered condition.
Detailed description
A total of 46 patients, aged 18-65, diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies, will be included in the study.Pain levels will be assessed using the Visual Analog Scale (VAS), and functional impairment will be measured with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological evaluations will be performed by a neurology specialist at the 1st and 3rd month follow-ups outside of working hours and without being billed to the Social Security Institution (SGK). VAS, BCTQ scores, and electrophysiological parameters will be evaluated at baseline, and at the 4th and 12th-week follow-ups post-treatment. Electrophysiological measurements will include median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) amplitudes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paraffin treatment group | – | Other: No interventionPatients with carpal tunnel syndrome who have received paraffin therapy |
| Injection group | – | Other: No interventionPatients with carpal tunnel syndrome who have applied ultrasound-guided steroid injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mild and moderate carpal tunnel syndrome
Key inclusion criteria (4 listed)
- Patients aged 18-65.
- Diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies.
- Received either ultrasound-guided corticosteroid injection or paraffin therapy.
- Symptoms persisting for at least 3 months.
Key exclusion criteria (2 listed)
- Diagnosis of other conditions causing neuropathic symptoms (e.g., polyneuropathy, brachial plexopathy, thoracic outlet syndrome).
- History of previous injection or surgery for carpal tunnel 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 |
|---|---|---|
| No interventionNo intervention | Other | Injection group, Paraffin treatment group |
Primary outcome
Visual Analog Scale (VAS):
Time frame: 0 day, 4th week and 12th week
The VAS will be used to measure pain intensity. Patients will mark their pain level on a 10 cm scale, where 0 represents "no pain" and 10 represents the "worst imaginable pain." This will be evaluated at baseline, and at the 4th and 12th weeks post-treatment.
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity Scale (BCTQ-SSS)
Time frame: 0 day, 4th week and 12th week
The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.
Boston Carpal Tunnel Syndrome Questionnaire Functional Status Scale (BCTQ-FSS)
Time frame: 0 day, 4th week and 12th week
The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.
6 secondary outcomes
Median nerve distal motor latency
Time frame: 0 day, 4th week and 12th week
Median nerve distal sensory latency
Time frame: 0 day, 4th week and 12th week
Sensory nerve conduction velocity
Time frame: 0 day, 4th week and 12th week
Motor nerve conduction velocity
Time frame: 0 day, 4th week and 12th week
Sensory nerve action potential amplitude
Time frame: 0 day, 4th week and 12th week
Motor nerve action potential amplitude
Time frame: 0 day, 4th week and 12th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra Şirin Ahısha, MD ((0212) 856 27 40, bsrn080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS): (time frame: 0 day, 4th week and 12th week). The study lists 3 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 12 Dec 2024.