Carpal Tunnel Syndrome (CTS)NCT06850779
Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments in Patients With Carpal Tunnel Syndrome
A study testing Extracorporeal shock wave therapy (ESWT), Kinesio taping (KT) and Exercise in people with Carpal Tunnel Syndrome (CTS), run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Carpal Tunnel Syndrome (CTS) is a common upper extremity nerve compression syndrome that causes significant economic and social burden to affected individuals. Although the severity may vary among patients, symptoms such as night pain, transient numbness, tingling, constant pain, muscle weakness, and sleep disturbance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Extracorporeal shock wave therapy (ESWT), Kinesio taping (KT) and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Mar 2024
- 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
- Mild to moderate unilateral carpal tunnel syndrome confirmed by electroneuromyography (ENMG)
- Patients over 18 years of age
- Symptom duration of at least 3 months
- Those who have not received any medical treatment other than analgesics in the last 3 months
Who cannot join
- Bilateral Carpal Tunnel Syndrome (CTS)
- Severe CTS detected by ENMG
- Operated CTS
- Corticosteroid injection within the last 3 months
- History of peripheral nerve damage
- Secondary CTS causes (thyroid dysfunction, connective tissue diseases)
Show all 12Show fewer
- Cervical disc herniation
- DeQuervain tenosynovitis, trigger finger, Dupuytren contracture
- Inflammatory disorder
- Bleeding disorder
- Pregnancy
- Malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments on Quality of Life, Hand Function and Median Nerve Cross-Sectional Area Measured by Ultrasonography in Patients With Carpal Tunnel Syndrome: A Single-Blind Randomized Controlled Trial
Carpal Tunnel Syndrome (CTS) is a common upper extremity nerve compression syndrome that causes significant economic and social burden to affected individuals. Although the severity may vary among patients, symptoms such as night pain, transient numbness, tingling, constant pain, muscle weakness, and sleep disturbance may be observed. The treatment of CTS can be grouped as nonsurgical and surgical treatments. The aim of this study is to investigate the effects of treatment with sound waves and a healing method called extracorporeal shock wave therapy and a therapeutic flexible tape called kinesiology taping on pain, grip strength, quality of life, depression symptoms, hand functions, and ultrasonographic median nerve cross-sectional area in patients with CTS.
Read the detailed description
Carpal tunnel syndrome is the most common nerve entrapment syndrome, typically affecting the dominant extremity. Symptoms often become more pronounced at night, and may include numbness, tingling, electric shock sensations, pain, and other related symptoms. Diagnosis can be made based on patient history, physical examination, electrodiagnostic tests, and ultrasonography. Treatment options include splinting, exercise therapy, physical therapy modalities, various injections, and surgical methods.
In our study, we compared the effects of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KT) on carpal tunnel syndrome. The study involved four randomized groups: Group 1 received both ESWT and KT, Group 2 received only ESWT, Group 3 received only KT, and Group 4 received exercise therapy alone. Evaluations were conducted using the Visual Analog Scale, Boston Carpal Tunnel Questionnaire, Douleur Neuropathique 4 Questions, Nottingham Health Profile, grip strength measurements, and median nerve cross-sectional area via ultrasonography. Evaluations were performed three times: before treatment, at week 3, and at week 6.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Extracorporeal shock wave therapy (ESWT), Kinesio taping (KT), Exercise
- Keywords
- carpal tunnel syndrome, extracorporeal shock wave therapy, kinesio taping
- 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.
Extracorporeal shock wave therapy (ESWT)Other
Radial ESWT (Vibrolith OrthoⓇ) was applied to the wrist as 1000 pulses with a frequency of 5 Hz and a power of 1.5 bar. The treatment was applied once a week for a total of 3 sessions.
Kinesio taping (KT)Other
KT was prepared as 2 pieces of 2.5 cm I band and 1 piece of 5 cm I band. It was applied with a maximum of 50% tension (without tension on the ends) while the wrist was in 30 degrees of extension, forearm supination and elbow extension. The treatment was applied once a week for a total of 3 sessions.
ExerciseOther
Median nerve gliding exercises were given to the 4th group during the follow-up period. The same exercises were given to the other groups.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Those who received both extracorporeal shock wave therapy (ESWT) and kinesio taping (KB) Receives: Other: Extracorporeal shock wave therapy (ESWT); Other: Kinesio taping (KT); Other: Exercise |
| Group 2 | Active comparator | Those who received ESWT Receives: Other: Extracorporeal shock wave therapy (ESWT); Other: Exercise |
| Group 3 | Active comparator | Those who received KT Receives: Other: Kinesio taping (KT); Other: Exercise |
| Group 4 | Other | Those who received only exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level before treatment, 3rd week and 6th week after treatment
Pain level will be evaluated with the Visual Analog Scale. (minimum: 0, maximum: 100 mm)
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of symptom severity and functionality
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) questionnaire was used to assess symptom severity and functionality. It includes 2 subgroups: Symptom Severity Scale (SSS) and Functional Status Scale (FSS). Symptom severity is assessed with 11 questions, and functional status is assessed with 8 questions. Each question is scored from low to high, 1 to 5. As the total score increases, deterioration increases.
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of median nerve cross sectional area by ultrasonography
The median nerve cross-sectional area was measured by tracing just proximal to the carpal tunnel entrance with the wrist resting on a table in a neutral position. The carpal tunnel entrance was identified by detecting the proximal side of the transverse carpal ligament. The distal radioulnar joint was also observed at this level.
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Secondary outcomes (5)
Assessment of grip strength and lateral pinch strength
A hydraulic hand dynamometer was used to assess grip strength, and a hydraulic pinchmeter was used to assess lateral pinch strength. Measurements were made using the 2nd level resistance (3.75 cm) with the elbow at 90 degrees of flexion and the forearm and wrist in a neutral position. Patients were asked to squeeze with maximum force, measurements were made three times, and the average result was recorded in kilograms. For lateral pinch (LP), the pinchmeter was pressed with the distal middle of the thumb, and the lateral part of the second phalanx of the index finger was used to support the lower part.
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of functionality
Duruöz Hand Index was used for functional assessment. This questionnaire contains 18 questions on hand activities. It consists of five areas. There are eight questions on kitchen activities, two questions on dressing, two questions on personal hygiene, two questions on office work and four questions on other activities. The patient selects one of the answers for each question on a scale of one to five. The scores given for each question are added to obtain a total score ranging from 0 to 90. Higher scores indicate more severe hand disability.
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of neuropathic pain
Douleur Neuropathique 4 Questions was used to assessment of neuropathic pain. The DN4 questionnaire consists of 10 items. The first 7 items are related to pain characteristics and sensation, while the remaining 3 items are related to examination. For each item, a score of "1" is given if the answer is "yes" and a score of "0" if the answer is "no". If the total number of yes answers from the 10 items is calculated as 4 or more, the patient is defined as having neuropathic pain.
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of quality of life
The Nottingham Health Profile was used.As a general health status questionnaire, it provides a brief indication of a patient's perceived emotional, social and physical health and is designed for use in the general population. It is concerned with the individual's health status and includes energy levels, pain, emotional responses, sleep, social isolation and physical abilities. The energy levels domain consists of 3 items, pain 8 items, emotional responses 9 items, sleep and social isolation domains 5 items each and physical abilities domain 8 items. Each item requires a yes or no response. The patient's score is calculated out of a total of 600 points. The higher the score, the lower the quality of life.
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of depression
Beck Depression Inventory was used for depression assessment. It consists of 21 items with four precursors scored between 0 and 3. Patients are asked to mark the item that best suits their mood in the past week. As the score increases, it is thought that the depressive state is more severe. The total score is scored as 0-9 = Minimal, 10-16 = mild, 17-29 = moderate, 30-63 = severe.
Measured: From enrollment to the end of treatment at 3rd week and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Oct 2023
- Primary completion30 Mar 2024
- Study completion30 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 Syndrome (CTS)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Banu Kuran, Professor, MD, Study director, Şişli Hamidiye Etfal Training and Research Hospital, Deparment of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850779
- Sponsor's protocol ID
- 26.09.2023/4106
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments on Quality of Life, Hand Function and Median Nerve Cross-Sectional Area Measured by Ultrasonography in Patients With Carpal Tunnel Syndrome: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06850779
- Acronym / sponsor ID
- 26.09.2023/4106
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- carpal tunnel syndrome, extracorporeal shock wave therapy, kinesio taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 27 Feb 2025 (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.
Carpal Tunnel Syndrome (CTS) is a common upper extremity nerve compression syndrome that causes significant economic and social burden to affected individuals. Although the severity may vary among patients, symptoms such as night pain, transient numbness, tingling, constant pain, muscle weakness, and sleep disturbance may be observed. The treatment of CTS can be grouped as nonsurgical and surgical treatments. The aim of this study is to investigate the effects of treatment with sound waves and a healing method called extracorporeal shock wave therapy and a therapeutic flexible tape called kinesiology taping on pain, grip strength, quality of life, depression symptoms, hand functions, and ultrasonographic median nerve cross-sectional area in patients with CTS.
Detailed description
Carpal tunnel syndrome is the most common nerve entrapment syndrome, typically affecting the dominant extremity. Symptoms often become more pronounced at night, and may include numbness, tingling, electric shock sensations, pain, and other related symptoms. Diagnosis can be made based on patient history, physical examination, electrodiagnostic tests, and ultrasonography. Treatment options include splinting, exercise therapy, physical therapy modalities, various injections, and surgical methods.
In our study, we compared the effects of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KT) on carpal tunnel syndrome. The study involved four randomized groups: Group 1 received both ESWT and KT, Group 2 received only ESWT, Group 3 received only KT, and Group 4 received exercise therapy alone. Evaluations were conducted using the Visual Analog Scale, Boston Carpal Tunnel Questionnaire, Douleur Neuropathique 4 Questions, Nottingham Health Profile, grip strength measurements, and median nerve cross-sectional area via ultrasonography. Evaluations were performed three times: before treatment, at week 3, and at week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Extracorporeal shock wave therapy (ESWT), Other: Kinesio taping (KT), Other: ExerciseThose who received both extracorporeal shock wave therapy (ESWT) and kinesio taping (KB) |
| Group 2 | Active comparator | Other: Extracorporeal shock wave therapy (ESWT), Other: ExerciseThose who received ESWT |
| Group 3 | Active comparator | Other: Kinesio taping (KT), Other: ExerciseThose who received KT |
| Group 4 | Other | Other: ExerciseThose who received only exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate unilateral carpal tunnel syndrome confirmed by electroneuromyography (ENMG)
- Patients over 18 years of age
- Symptom duration of at least 3 months
- Those who have not received any medical treatment other than analgesics in the last 3 months
Key exclusion criteria (12 listed)
- Bilateral Carpal Tunnel Syndrome (CTS)
- Severe CTS detected by ENMG
- Operated CTS
- Corticosteroid injection within the last 3 months
- History of peripheral nerve damage
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 |
|---|---|---|
| Extracorporeal shock wave therapy (ESWT)Radial ESWT (Vibrolith OrthoⓇ) was applied to the wrist as 1000 pulses with a frequency of 5 Hz and a power of 1.5 bar. The treatment was applied once a week for a total of 3 sessions. | Other | Group 1, Group 2 |
| Kinesio taping (KT)KT was prepared as 2 pieces of 2.5 cm I band and 1 piece of 5 cm I band. It was applied with a maximum of 50% tension (without tension on the ends) while the wrist was in 30 degrees of extension, forearm supination and elbow extension. The treatment was applied once a week for a total of 3 sessions. | Other | Group 1, Group 3 |
| ExerciseMedian nerve gliding exercises were given to the 4th group during the follow-up period. The same exercises were given to the other groups. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Pain level before treatment, 3rd week and 6th week after treatment
Time frame: From enrollment to the end of treatment at 3rd week and 6th week
Pain level will be evaluated with the Visual Analog Scale. (minimum: 0, maximum: 100 mm)
Assessment of symptom severity and functionality
Time frame: From enrollment to the end of treatment at 3rd week and 6th week
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) questionnaire was used to assess symptom severity and functionality. It includes 2 subgroups: Symptom Severity Scale (SSS) and Functional Status Scale (FSS). Symptom severity is assessed with 11 questions, and functional status is assessed with 8 questions. Each question is scored from low to high, 1 to 5. As the total score increases, deterioration increases.
Assessment of median nerve cross sectional area by ultrasonography
Time frame: From enrollment to the end of treatment at 3rd week and 6th week
The median nerve cross-sectional area was measured by tracing just proximal to the carpal tunnel entrance with the wrist resting on a table in a neutral position. The carpal tunnel entrance was identified by detecting the proximal side of the transverse carpal ligament. The distal radioulnar joint was also observed at this level.
5 secondary outcomes
Assessment of grip strength and lateral pinch strength
Time frame: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of functionality
Time frame: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of neuropathic pain
Time frame: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of quality of life
Time frame: From enrollment to the end of treatment at 3rd week and 6th week
Assessment of depression
Time frame: From enrollment to the end of treatment at 3rd week and 6th 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 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Banu Kuran, Professor, MD study director
Şişli Hamidiye Etfal Training and Research Hospital, Deparment of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy (ESWT), Kinesio taping (KT) and Exercise in people with Carpal Tunnel Syndrome (CTS), run by Sisli Hamidiye Etfal Training 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 4 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 27 Feb 2025. 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?
Pain level before treatment, 3rd week and 6th week after treatment (time frame: From enrollment to the end of treatment at 3rd week and 6th 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 27 Feb 2025.