Carpal Tunnel SyndromePhase 4NCT06349265
Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome
A Phase 4 study testing Carpal Tunnel Hydrodissection with %5 dextrose in water injection in people with Carpal Tunnel Syndrome, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Carpal Tunnel Hydrodissection with %5 dextrose in water injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 2 Mar 2024
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
- Sensory loss with numbness in the median nerve-innervated regions of the hand.
- Weakness with atrophy of the median nerve-innervated thenar muscles.
- Positive Phalen's test and/or Tinel's sign.
- The diagnosis should be confirmed with electrodiagnostic studies.
Who cannot join
- History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
- History of systematic infection, and rheumatologic disorders.
- Previous steroid injection for carpal tunnel syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Analysis of the Efficacy of Ultrasound-Guided Injection of 5% Dextrose in Water for the Treatment of Mild to Severe Carpal Tunnel Syndrome
This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal Tunnel Hydrodissection with %5 dextrose in water injection
- Keywords
- dextrose, carpal tunnel syndrome, 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.
Carpal Tunnel Hydrodissection with %5 dextrose in water injectionDrug
Under the inplane ulnar approach, 3ml injectate was injected to hydrodissect the median nerve from the flexor retinaculum, and the residual 2ml injectate was then injected to hydrodissect the inferior median nerve away from the flexor tendons.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Mild Carpal Tunnel syndrome Receives: Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection |
| Group 2 | Active comparator | Moderate Carpal Tunnel Syndrome Receives: Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection |
| Group 3 | Active comparator | Severe Carpal Tunnel Syndrome Receives: Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale(VAS)
VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line. The Turkish version of the assessment has been validated and shown to be reliable.
Measured: At the beginning, 1.,4., 12. week
Secondary outcomes (2)
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
The Boston Carpal Tunnel Questionnaire (BCTQ) comprises two subscales. The Symptom Severity Scale provides data on symptom intensity, while the Functional Status Scale assesses hand function. The Symptom Severity Scale comprises 11 items evaluating pain, paresthesia, numbness, weakness, night symptoms, and difficulty grasping. Meanwhile, the Functional Status Scale includes eight items assessing functional deficits in writing, buttoning clothes, holding a book while reading, gripping a phone handle, opening jars, performing household chores, carrying a shopping bag, bathing, and dressing.
Each item is scored from 1 (no symptoms/no difficulty) to 5 (worst symptom or cannot perform the activity at all). The average score of each scale yields a score between 1 and 5, with higher scores indicating more severe symptoms or functional impairments.A Turkish validity and reliability study has been conducted.
Measured: At the beginning, 1.,4., 12. week
Dolour Neuropathique en 4 Questions (DN4) questionnaire
The DN4 (Dolour Neuropathique en 4 Questions) questionnaire is a screening tool designed to aid in diagnosing neuropathic pain. Developed in 2005, it consists of ten items, with seven questions focusing on sensory symptoms and three on signs related to neuropathic pain. The questions cover various characteristics of neuropathic pain, such as burning, tingling, and sensitivity to touch. Turkish validity and reliability measures were established for its use.
Measured: At the beginning, 1.,4., 12. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start2 Oct 2023
- Primary completion2 Feb 2024
- Study completion2 Mar 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Gul Gulec, Kastamonu University
- Investigators
- Emre Özmen, Study chair, İstanbul Physical Medicine and Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349265
- Sponsor's protocol ID
- 02
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- 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 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of the Efficacy of Ultrasound-Guided Injection of 5% Dextrose in Water for the Treatment of Mild to Severe Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06349265
- Acronym / sponsor ID
- 02
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- dextrose, carpal tunnel syndrome, ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 5 Apr 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.
This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injectionMild Carpal Tunnel syndrome |
| Group 2 | Active comparator | Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injectionModerate Carpal Tunnel Syndrome |
| Group 3 | Active comparator | Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injectionSevere Carpal Tunnel Syndrome |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
- Sensory loss with numbness in the median nerve-innervated regions of the hand.
- Weakness with atrophy of the median nerve-innervated thenar muscles.
- Positive Phalen's test and/or Tinel's sign.
- The diagnosis should be confirmed with electrodiagnostic studies.
Key exclusion criteria (3 listed)
- History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
- History of systematic infection, and rheumatologic disorders.
- Previous steroid injection 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 |
|---|---|---|
| Carpal Tunnel Hydrodissection with %5 dextrose in water injectionUnder the inplane ulnar approach, 3ml injectate was injected to hydrodissect the median nerve from the flexor retinaculum, and the residual 2ml injectate was then injected to hydrodissect the inferior median nerve away from the flexor tendons. | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Visual Analogue Scale(VAS)
Time frame: At the beginning, 1.,4., 12. week
VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line. The Turkish version of the assessment has been validated and shown to be reliable.
2 secondary outcomes
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time frame: At the beginning, 1.,4., 12. week
Dolour Neuropathique en 4 Questions (DN4) questionnaire
Time frame: At the beginning, 1.,4., 12. week
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 Apr 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. This study is not recruiting at the moment.
Emre Özmen study chair
İstanbul Physical Medicine and Rehabilitation Hospital
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 Carpal Tunnel Hydrodissection with %5 dextrose in water injection in people with Carpal Tunnel Syndrome, run by Kastamonu University 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 5 inclusion and 3 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 Apr 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?
Visual Analogue Scale(VAS) (time frame: At the beginning, 1.,4., 12. week). 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 Apr 2024.