Carpal Tunnel SyndromePhase 4NCT06282640
Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome
A Phase 4 study testing Vitamin D in people with Carpal Tunnel Syndrome and Vitamin D Deficiency, run by Dr. Ayşe Güç at 1 site in Turkey (Türkiye).
Trial summary
Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 30 Aug 2022
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old male or female gender
- Those with mild to moderate CTS according to ENMG,
- Vitamin D level <20.
Who cannot join
- Severe CTS according to ENMG
- Thenar region atrophy
- diabetes mellitus,
- rheumatoid arthritis,
- hyperthyroidism,
- hypothyroidism
Show all 12Show fewer
- Traumatic nerve injury, history of surgery
- Polyneuropathy
- Pregnancy
- Severe psychiatric illness
- Poor orientation and cooperation,
- Injection (corticosteroid, ozone, stem cell…) applied for CTS treatment within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels.
Read the detailed description
Introduction: Apart from its effect on bone health, vitamin D is also known to have beneficial effects on the neurological system. In studies, vitamin D levels were found to be low in patients with Carpal Tunnel Syndrome (CTS). However, studies examining the effects of vitamin D replacement on CTS are limited. Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. Materials and Methods: Our study was planned as an observational and analytical prospective. Vitamin D loading therapy was given to patients with serum vitamin D levels below 20ng/ml and mild-moderate CTS detected by electroneuromyography (ENMG). Patients with vitamin D levels above 20 ng/ml after 8 weeks were included in the study. Each patient was given a rest splint and exercise program. Patients were evaluated before and 3 months after treatment with electrophysiological, ultrasonographic, VAS, pinch-grip strength, two-point discrimination, monofilament test and Boston symptom severity scale.
- Conditions
- Carpal Tunnel Syndrome, Vitamin D Deficiency
- Being tested
- Vitamin D
- Keywords
- Carpal Tunnel Syndrome, Vitamin D Deficiency, Electrophysiologia
- Medical subject headings
- Carpal Tunnel Syndrome, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D replacement therapy was administered at 50,000 IU weekly for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D in Carpal Tunnel Syndrome | Experimental | Not described Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrophysiological scale.
Electrophysiological Evaluation: Neurowerk (SIGMA-Medizin-TechnicGmbH/Germany) brand ENMG device was used. Patients were evaluated at room temperature of approximately 25 °C. All measurements were made by the same doctor. Our clinic's reference values for the diagnosis of CTS are shown below
Measured: at the baseline and immediately after treatment
Secondary outcomes (1)
monofilament test
Semmes-Weinstein monofilament test (SWMT): The first three fingertips on the palmar surface of the hand included with the 6-monofilament set of Baseline company were evaluated. Monofilament number 2.83 was taken as the threshold value for normal sensory value. SWMT was applied blindly by the same occupational therapist who was unaware of the patients' disease and the treatment they received.
Measured: at the baseline and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start30 Dec 2021
- Primary completion30 Jun 2022
- Study completion30 Aug 2022
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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ayşe Güç
- Sponsor type
- Other government
- Collaborators
- Kayseri City Hospital
- Responsible party
- Sponsor-investigator, Dr. Ayşe Güç, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282640
- Sponsor's protocol ID
- 567
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06282640
- Acronym / sponsor ID
- 567
- Conditions
- Carpal Tunnel Syndrome, Vitamin D Deficiency
- Keywords
- Carpal Tunnel Syndrome, Vitamin D Deficiency, Electrophysiologia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Dr. Ayşe GüçOther government
- Collaborators
- Kayseri City Hospital
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 28 Feb 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.
Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels.
Detailed description
Introduction: Apart from its effect on bone health, vitamin D is also known to have beneficial effects on the neurological system. In studies, vitamin D levels were found to be low in patients with Carpal Tunnel Syndrome (CTS). However, studies examining the effects of vitamin D replacement on CTS are limited. Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. Materials and Methods: Our study was planned as an observational and analytical prospective. Vitamin D loading therapy was given to patients with serum vitamin D levels below 20ng/ml and mild-moderate CTS detected by electroneuromyography (ENMG). Patients with vitamin D levels above 20 ng/ml after 8 weeks were included in the study. Each patient was given a rest splint and exercise program. Patients were evaluated before and 3 months after treatment with electrophysiological, ultrasonographic, VAS, pinch-grip strength, two-point discrimination, monofilament test and Boston symptom severity scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D in Carpal Tunnel Syndrome | Experimental | Drug: Vitamin D |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years old male or female gender
- Those with mild to moderate CTS according to ENMG,
- Vitamin D level <20.
Key exclusion criteria (12 listed)
- Severe CTS according to ENMG
- Thenar region atrophy
- diabetes mellitus,
- rheumatoid arthritis,
- hyperthyroidism,
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 |
|---|---|---|
| Vitamin DVitamin D replacement therapy was administered at 50,000 IU weekly for 8 weeks. | Drug | Vitamin D in Carpal Tunnel Syndrome |
Primary outcome
electrophysiological scale.
Time frame: at the baseline and immediately after treatment
Electrophysiological Evaluation: Neurowerk (SIGMA-Medizin-TechnicGmbH/Germany) brand ENMG device was used. Patients were evaluated at room temperature of approximately 25 °C. All measurements were made by the same doctor. Our clinic's reference values for the diagnosis of CTS are shown below
1 secondary outcome
monofilament test
Time frame: at the baseline and immediately after treatment
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 28 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Carpal Tunnel Syndrome and Vitamin D Deficiency, run by Dr. Ayşe Güç 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 3 inclusion and 12 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 28 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
electrophysiological scale. (time frame: at the baseline and immediately after treatment). 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 28 Feb 2024.