Carpal Tunnel SyndromePhase 4NCT03792945
Comparison of the Efficacy of Corticosteroid Injection and ESWT in Patients With CTS
A Phase 4 study testing local injection and extracorporeal shock wave therapy in people with Carpal Tunnel Syndrome and Tenosynovitis, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection in patients with carpal tunnel syndrome(CTS) compared to participants receiving only splint and exercise therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Tenosynovitis
- What is being tested?
- local injection and extracorporeal shock wave therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2019to 29 May 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis diagnosed between 18-65 years of age with clinical and EMG.
- Patients who are able to understand and correctly understand the patient information form
- Patients consenting to participate in the study according to the informed consent form
Who cannot join
- Cervical radiculopathy
- Polyneuropathy
- Brachial plexopathy
- Systemic corticosteroid treatment
- Fracture and trauma history of the treated side anterior arm and wrist
- Inflammatory rheumatic disease
Show all 14Show fewer
- Pregnant and lactating patients
- Patients with cardiac pacemakers
- Patients undergoing carpal tunnel syndrome surgery
- Thoracic outlet syndrome
- Severe atrophy
- Severe carpal tunnel syndrome
- Patients who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the patient is not in favor of the patient,
- Systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evran University Education and Research Hospital
Kırşehir
About this study
Official title: Comparison of the Efficacy of Corticosteroid Injection and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Carpal Tunnel Syndrome; A Prospective Randomized Controlled Trial
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection in patients with carpal tunnel syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded.The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.
And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer.
Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.
Read the detailed description
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid treatment, fracture and trauma history of the treated side anterior arm and wrist, inflammatory rheumatic disease, pregnant and lactating participants, participants with cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the participants is not in favor of the participants, systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90 idiopathic moderate and mild CTS participants will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded. The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.
And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.
- Conditions
- Carpal Tunnel Syndrome, Tenosynovitis
- Being tested
- local injection, extracorporeal shock wave therapy
- Keywords
- extracorporeal shock wave therapy, corticosteroid injection
- Medical subject headings
- Carpal Tunnel Syndrome, Tenosynovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local injectionDrug
Also called local corticosteroid injection
In addition to the local injection, carpal tunnel brace will be given.
extracorporeal shock wave therapyDevice
Also called physiotheraphy
In addition to all ESWT participants, carpal tunnel brace will be given.
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal shock wave therapy | Active comparator | ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months. Receives: Device: extracorporeal shock wave therapy |
| local injection | Active comparator | 40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months. Receives: Drug: local injection |
| carpal tunnel wrist brace | No intervention | Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) - Pain
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.
Measured: 3. months after treatment
Visual Analog Scale (VAS) - Numbness
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.
Measured: 3. months after treatment
Secondary outcomes (8)
hand clamping force
Hand grip strength measurement using Jamar hydraulic hand dynamometer. Hand grip strength measurements will be performed using the elbow at 90 degrees of flexion, while the forearm and wrist is in neutral position using resistance at level 2. Measurements shall be performed three times, and the average result shall be recorded in kilograms (kg) for each hand separately.
Measured: 3. months after treatment
boston scale
Boston symptom severity score(SSS) and improvement in functional status score(FSS). There are 11 questions at SSS. Responses vary from 'none(1 point)' to 'very severe(5 points)'. There are 8 questions in FSS. Responses vary from 'very easy (1 point)' to 'very difficult (5 points) according to difficulty level. In both scales, the degree of symptom severity and dysfunction increases as the total score increases.The score of the patient is divided by the total score (total score is 11x5 = 55 for the SSS and the total score is 8x5 = 40 for FSS) and 0 to 1 for each patient. As this ratio reaches 1, the degree of symptom severity and dysfunction of the patient increases. For example; Considering that the total score obtained from all the questions in the SPS is 22, the ratio of 22/55 = 0. 4 is obtained.These scales will be applied after treatment and the rates obtained before and after treatment will be compared.
Measured: 3. months after treatment
Median nerve sensory distal latency(electrophysiological examination,physiological parameter)
Evaluation of median nerve sensory distal latency: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. On EMG examination, sensory distal latency was greater than 3.6 ms and CTS was accepted.
Measured: 3. months after treatment
Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)
Evaluation of median nerve sensory transmission rate: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. Emotional nerve conduction velocity lower than 50 m/s in EMG examination will be accepted as CTS.
Measured: 3. months after treatment
Median nerve motor distal latency( electrophysiological examination, physiological parameter)
Evaluation of median nerve motor distal latency : The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. In the EMG examination, if the motor distal latency is over 4.2 ms, CTS will be accepted.
Measured: 3. months after treatment
Median nerve motor transmission rate ( electrophysiological examination, physiological parameter)
Evaluation of median nerve motor transmission rate: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist.
Measured: 3. months after treatment
Median sensory nerve action potential amplitude
Evaluation of Median sensory nerve action potential amplitude: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. In the emg examination, the median sensory nerve action potential amplitude below 10 microvolts will be accepted as CTS.
Measured: 3. months after treatment
Compound muscle action potential amplitude
Evaluation of compound muscle action potential amplitude: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. The median CBAP amplitude below 5 millivolt in the recording of APB muscle in the emg examination will be accepted as CTS.
Measured: 3. months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start20 Jan 2019
- Primary completion29 Apr 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Öztürk Durmaz, Ahi Evran University Education and Research Hospital
- Investigators
- Havva ÖZTÜRK DURMAZ, Principal investigator, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792945
- Sponsor's protocol ID
- AhiEvranUERH
- Status last verified
- Apr 2020
- First submitted
- 7 Dec 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ozturk Durmaz H, Tuncay F, Durmaz H, Erdem HR. Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Jul 1;101(7):685-692. doi: 10.1097/PHM.0000000000001891. Epub 2021 Oct 4.
PubMed 35706121
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Corticosteroid Injection and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Carpal Tunnel Syndrome; A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03792945
- Acronym / sponsor ID
- AhiEvranUERH
- Conditions
- Carpal Tunnel Syndrome, Tenosynovitis
- Keywords
- extracorporeal shock wave therapy, corticosteroid injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 4 Jan 2019 (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.
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection in patients with carpal tunnel syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded.The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.
And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer.
Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.
Detailed description
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid treatment, fracture and trauma history of the treated side anterior arm and wrist, inflammatory rheumatic disease, pregnant and lactating participants, participants with cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the participants is not in favor of the participants, systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90 idiopathic moderate and mild CTS participants will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded. The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.
And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| extracorporeal shock wave therapy | Active comparator | Device: extracorporeal shock wave therapyESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months. |
| local injection | Active comparator | Drug: local injection40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months. |
| carpal tunnel wrist brace | No intervention | –Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis diagnosed between 18-65 years of age with clinical and EMG.
- Patients who are able to understand and correctly understand the patient information form
- Patients consenting to participate in the study according to the informed consent form
Key exclusion criteria (14 listed)
- Cervical radiculopathy
- Polyneuropathy
- Brachial plexopathy
- Systemic corticosteroid treatment
- Fracture and trauma history of the treated side anterior arm and wrist
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 |
|---|---|---|
| local injectionAlso: local corticosteroid injectionIn addition to the local injection, carpal tunnel brace will be given. | Drug | local injection |
| extracorporeal shock wave therapyAlso: physiotheraphyIn addition to all ESWT participants, carpal tunnel brace will be given. | Device | extracorporeal shock wave therapy |
Primary outcome
Visual Analog Scale (VAS) - Pain
Time frame: 3. months after treatment
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.
Visual Analog Scale (VAS) - Numbness
Time frame: 3. months after treatment
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.
8 secondary outcomes
hand clamping force
Time frame: 3. months after treatment
boston scale
Time frame: 3. months after treatment
Median nerve sensory distal latency(electrophysiological examination,physiological parameter)
Time frame: 3. months after treatment
Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)
Time frame: 3. months after treatment
Median nerve motor distal latency( electrophysiological examination, physiological parameter)
Time frame: 3. months after treatment
Median nerve motor transmission rate ( electrophysiological examination, physiological parameter)
Time frame: 3. months after treatment
Median sensory nerve action potential amplitude
Time frame: 3. months after treatment
Compound muscle action potential amplitude
Time frame: 3. months 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 Apr 2020.
- Derived from this study: PubMed 35706121Ozturk Durmaz H, Tuncay F, Durmaz H, Erdem HR. Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Jul 1;101(7):685-692. doi: 10.1097/PHM.0000000000001891. Epub 2021 Oct 4.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Havva ÖZTÜRK DURMAZ principal investigator
Ahi Evran University Education and Research 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 local injection and extracorporeal shock wave therapy in people with Carpal Tunnel Syndrome and Tenosynovitis, run by Ahi Evran University Education and Research 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 3 inclusion and 14 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 Apr 2020. 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 Analog Scale (VAS) - Pain (time frame: 3. months after treatment). The study lists 2 primary outcomes in all. 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 NCT03792945, 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 28 Apr 2020.