Carpal Tunnel SyndromeNCT05343351
Effect of Out of Plane and In Plane Injection Techniques in Patients With Carpal Tunnel Syndrome
A study testing Technique of injection method in people with Carpal Tunnel Syndrome and Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study, using two different injection techniques, 1. To evaluate the patients in terms of the pain they feel during the application of carpal tunnel syndrome (CTS) injection, 2. Evaluation in terms of undesirable effects developing after injection, 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, Pain, Carpal Tunnel
- What is being tested?
- Technique of injection method
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 21 Feb 2023
- 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
- Age ≥18
- Numbness and tingling in the median nerve innervation area with or without pain
- Worsening of symptoms at night
- Positive Tinel and/or Phalen sign
- Symptom duration longer than 12 weeks
- Electrophysiologically mild or moderate CTS being diagnosed.
Who cannot join
- Presence of conditions such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome that may mimic CTS
- Presence of multiple entrapment neuropathy
- Weakness in hand thumb abduction or opposition
- Thenar atrophy
- Presence of wrist corticosteroid and/or local anesthetic injection
- Regular use of medical treatment such as oral corticosteroids or NSAIDs
Show all 17Show fewer
- Having entered a physical therapy program due to CTS in the last 6 months before the injection
- A history of trauma or arthritis attack at the wrist level
- Previous surgery due to CTS
- Thyroid diseases, diabetes, chronic kidney failure
- Having bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis or tendinitis on wrist USG
- Rheumatological disease (rheumatoid arthritis, ankylosing spondylitis, systemic lupus) erythematosus, vasculitis, systemic sclerosis, dermatomyositis)
- Presence of malignancy
- Pregnant or breastfeeding mothers
- Infection or skin lesion at the injection site
- Use of wrist splints in the last 4 weeks
- Allergy to corticosteroids or local anesthetics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul
About this study
Official title: The Effect of Out of Plane and In Plane Injection Techniques on Injection Pain and Functionality in Patients With Carpal Tunnel Syndrome Undergoing Ultrasound-Guided Injection: A Randomized, Double-Blind Study
The aim of this study, using two different injection techniques,
- To evaluate the patients in terms of the pain they feel during the application of carpal tunnel syndrome (CTS) injection,
- Evaluation in terms of undesirable effects developing after injection,
- To evaluate the degree of pain/drowsiness, symptom severity and functionality, and median nerve diameter at the end of the first month after the injection, and to evaluate the relationship of these parameters with the pain felt by the patients during the injection.
Read the detailed description
Among the evaluated patients, the patients who met the inclusion and exclusion criteria and accepted the carpal tunnel syndrome injection will be randomized into 2 groups using the random numbers table.
One group will be injected using the out-of-plane technique under ultrasound, and the other group will be injected using the in-plane technique. Patients will be evaluated before the treatment, at the 1st hour after the injection and at the end of the 4th week after the injection.
Randomization and injection of the patients will be done by Dr Gül Tuğba Bulut, while the evaluation of the patients and the sonographic evaluation of the median nerve will be done by Dr Alper Mengi.
Age, gender, education level, body mass index, duration of symptoms, dominant hand, injection hand, and carpal tunnel syndrome severity detected in EMG of the patients included in the study will be recorded.
The patients will be questioned about the pain they feel during the injection at the end of the 1st hour after the injection, while the degree of pain/numbness in the wrist and finger, symptom severity and functionality, and median nerve diameter are evaluated at the end of the 4th week before and after the injection.
Patients will be questioned about undesirable effects at the end of the 4th week after the injection.
- Conditions
- Carpal Tunnel Syndrome, Pain, Carpal Tunnel
- Being tested
- Technique of injection method
- Medical subject headings
- Carpal Tunnel Syndrome, Pain, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technique of injection methodOther
In 'out of plane group', the ultrasound probe will be placed at the entrance level of the proximal carpal tunnel (scaphoid-pisiform plane), the ulnar edge of the median nerve will be taken to the midpoint of the probe, and then the needle will be inserted from the middle point of the probe with the out of plane method. Then the needle will be advanced towards the ulnar side of the median nerve and the injection content will be given into the tunnel.
In 'in plane group group', the ultrasound probe will be placed at the proximal carpal tunnel entrance level (scaphoid-pisiform plane), it will be entered at a cross angle between the ulnar artery and the median nerve with the in-plane method, and be advanced under the median nerve, and then the injection content will be given into the carpal tunnel.
| Study group | Role | What they receive |
|---|---|---|
| Out of Plane arm | Experimental | The patient group who was injected using the ultrasound-guided out of plane injection method. Receives: Other: Technique of injection method |
| In Plane arm | Experimental | The group of patients who were injected using the ultrasound-guided in-plane injection method. Receives: Other: Technique of injection method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain during injection
Patients will be asked to rate the average level of pain they feel during the injection as absent, mild, moderate, severe, and unbearable.
Measured: 1 hour
Pain/Numbness Evaluation
The severity of pain and numbness of the patients will be questioned by visual analog scale (VAS). A horizontal straight line 10 cm long will be used in the VAS assessment. The patient will be told that a value of 0 represents no pain and numbness, and a value of 10 represents the most severe pain and numbness he has ever felt. In each evaluation, the average of the day and night pain/numbness severity over the last 3 days will be questioned.
Measured: 3 days
Evaluation of symptom severity and functionality
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) with Turkish validity and reliability will be used to evaluate the symptom severity and functionality of the patients. BCTQ is a self-filled questionnaire consisting of two parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has five different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom. Average scores are calculated separately for symptom severity and functional status.
Measured: 3 days
Evaluation of undesirable effects
At the controls at the end of the 4th week after the injection, the patients had skin discoloration or fat atrophy, steroid exacerbation (transient pain that started at the 24th hour after the injection and lasted an average of 2-5 days after the injection), superficial infection and median nerve irritation (from the injection). Finger numbness or weakness lasting more than 2 weeks after injection, increasing compared to pre-injection) will be evaluated.
Measured: 1 day
Sonographic evaluation of the median nerve
Ultrasonographic evaluation will be performed with an 18-6 MHz superficial linear probe (Esaote MyLab Five LA435 Transducer). Fixed frequency and depth settings will be used for all measurements. During the examination, patients will be performed in a sitting position facing the clinician, with the elbow in 90° flexion, the forearm supinated, and the fingers in the semi-flexion position. The examination will begin by seeing the median nerve in the axial plane at the wrist localization, and the cross-sectional area of the median nerve (MSCA) will be measured with the probe at the level of the psiform and scaphoid bone. In the measurements, the hyperechoic sheath will be excluded from the drawing and the manual trace method available in the USG device will be used. Square millimeter (mm2) unit will be used for area values in all measurements. All measurements will be made in triplicate and the average of the three measurements will be taken.
Measured: 1 day
Descriptive information
Age, gender, education level, body mass index, duration of symptoms, dominant hand, injection hand, and CTS severity detected in EMG of the patients included in the study will be recorded.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2022
- Study completion21 Feb 2023
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Training and Research Hospital
- Responsible party
- Principal investigator, Alper mengi, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343351
- Sponsor's protocol ID
- 25.03.2022/109
- Status last verified
- Feb 2023
- First submitted
- 18 Apr 2022
- Last updated
- 28 Feb 2023
- 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 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Out of Plane and In Plane Injection Techniques on Injection Pain and Functionality in Patients With Carpal Tunnel Syndrome Undergoing Ultrasound-Guided Injection: A Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT05343351
- Acronym / sponsor ID
- 25.03.2022/109
- Conditions
- Carpal Tunnel Syndrome, Pain, Carpal Tunnel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Istanbul Training and Research Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 25 Apr 2022 (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, using two different injection techniques,
- To evaluate the patients in terms of the pain they feel during the application of carpal tunnel syndrome (CTS) injection,
- Evaluation in terms of undesirable effects developing after injection,
- To evaluate the degree of pain/drowsiness, symptom severity and functionality, and median nerve diameter at the end of the first month after the injection, and to evaluate the relationship of these parameters with the pain felt by the patients during the injection.
Detailed description
Among the evaluated patients, the patients who met the inclusion and exclusion criteria and accepted the carpal tunnel syndrome injection will be randomized into 2 groups using the random numbers table.
One group will be injected using the out-of-plane technique under ultrasound, and the other group will be injected using the in-plane technique. Patients will be evaluated before the treatment, at the 1st hour after the injection and at the end of the 4th week after the injection.
Randomization and injection of the patients will be done by Dr Gül Tuğba Bulut, while the evaluation of the patients and the sonographic evaluation of the median nerve will be done by Dr Alper Mengi.
Age, gender, education level, body mass index, duration of symptoms, dominant hand, injection hand, and carpal tunnel syndrome severity detected in EMG of the patients included in the study will be recorded.
The patients will be questioned about the pain they feel during the injection at the end of the 1st hour after the injection, while the degree of pain/numbness in the wrist and finger, symptom severity and functionality, and median nerve diameter are evaluated at the end of the 4th week before and after the injection.
Patients will be questioned about undesirable effects at the end of the 4th week after the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Out of Plane arm | Experimental | Other: Technique of injection methodThe patient group who was injected using the ultrasound-guided out of plane injection method. |
| In Plane arm | Experimental | Other: Technique of injection methodThe group of patients who were injected using the ultrasound-guided in-plane injection method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18
- Numbness and tingling in the median nerve innervation area with or without pain
- Worsening of symptoms at night
- Positive Tinel and/or Phalen sign
- Symptom duration longer than 12 weeks
Key exclusion criteria (17 listed)
- Presence of conditions such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome that may mimic CTS
- Presence of multiple entrapment neuropathy
- Weakness in hand thumb abduction or opposition
- Thenar atrophy
- Presence of wrist corticosteroid and/or local anesthetic injection
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 |
|---|---|---|
| Technique of injection methodIn 'out of plane group', the ultrasound probe will be placed at the entrance level of the proximal carpal tunnel (scaphoid-pisiform plane), the ulnar edge of the median nerve will be taken to the midpoint of the probe, and then the needle will be inserted from the middle point of the probe with the out of plane method. Then the needle will be advanced towards the ulnar side of the median nerve and the injection content will be given into the tunnel. In 'in plane group group', the ultrasound probe will be placed at the proximal carpal tunnel entrance level (scaphoid-pisiform plane), it will be entered at a cross angle between the ulnar artery and the median nerve with the in-plane method, and be advanced under the median nerve, and then the injection content will be given into the carpal tunnel. | Other | In Plane arm, Out of Plane arm |
Primary outcome
Assessment of pain during injection
Time frame: 1 hour
Patients will be asked to rate the average level of pain they feel during the injection as absent, mild, moderate, severe, and unbearable.
Pain/Numbness Evaluation
Time frame: 3 days
The severity of pain and numbness of the patients will be questioned by visual analog scale (VAS). A horizontal straight line 10 cm long will be used in the VAS assessment. The patient will be told that a value of 0 represents no pain and numbness, and a value of 10 represents the most severe pain and numbness he has ever felt. In each evaluation, the average of the day and night pain/numbness severity over the last 3 days will be questioned.
Evaluation of symptom severity and functionality
Time frame: 3 days
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) with Turkish validity and reliability will be used to evaluate the symptom severity and functionality of the patients. BCTQ is a self-filled questionnaire consisting of two parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has five different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom. Average scores are calculated separately for symptom severity and functional status.
Evaluation of undesirable effects
Time frame: 1 day
At the controls at the end of the 4th week after the injection, the patients had skin discoloration or fat atrophy, steroid exacerbation (transient pain that started at the 24th hour after the injection and lasted an average of 2-5 days after the injection), superficial infection and median nerve irritation (from the injection). Finger numbness or weakness lasting more than 2 weeks after injection, increasing compared to pre-injection) will be evaluated.
Sonographic evaluation of the median nerve
Time frame: 1 day
Ultrasonographic evaluation will be performed with an 18-6 MHz superficial linear probe (Esaote MyLab Five LA435 Transducer). Fixed frequency and depth settings will be used for all measurements. During the examination, patients will be performed in a sitting position facing the clinician, with the elbow in 90° flexion, the forearm supinated, and the fingers in the semi-flexion position. The examination will begin by seeing the median nerve in the axial plane at the wrist localization, and the cross-sectional area of the median nerve (MSCA) will be measured with the probe at the level of the psiform and scaphoid bone. In the measurements, the hyperechoic sheath will be excluded from the drawing and the manual trace method available in the USG device will be used. Square millimeter (mm2) unit will be used for area values in all measurements. All measurements will be made in triplicate and the average of the three measurements will be taken.
Descriptive information
Time frame: 1 day
Age, gender, education level, body mass index, duration of symptoms, dominant hand, injection hand, and CTS severity detected in EMG of the patients included in the study will be recorded.
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 2023.
- 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.
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 study testing Technique of injection method in people with Carpal Tunnel Syndrome and Pain, run by Istanbul University - Cerrahpasa 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 6 inclusion and 17 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 2023. 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?
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?
Assessment of pain during injection (time frame: 1 hour). The study lists 6 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 28 Feb 2023.