Carpal Tunnel SyndromeNCT06469931
Ozone Therapy in Patients With Carpal Tunnel Syndrome
A study testing range of motion exercises, Extracorporeal shock wave therapy and ozone therapy in people with Carpal Tunnel Syndrome, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- range of motion exercises, Extracorporeal shock wave therapy and ozone therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 20 Sep 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-65 who have been complaining for at least 3 months
- Diagnosed with mild or moderate Carpal Tunnel Syndrome
Who cannot join
- Cervical disc herniation or radiculopathy,
- Brachial plexus lesion
- Previous hand or neck surgery
- Pregnancy,
- History of fracture at the wrist level
- Inflammatory rheumatic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, songulbaglan23@hotmail.com
About this study
Official title: Comparison of the Effectiveness of ESWT and Ozone Therapy in Patients With Carpal Tunnel Syndrome
ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy resulting from compression of the median nerve at the wrist level. Various methods are applied in the conservative treatment of CTS. These include modification of daily life, splinting, physical therapy modalities and exercise methods. ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Ozone therapy has trophic effects, analgesic effects, antioxidant, immunomodulator, anti-inflammatory and antitumoral effects. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting. Ultrasonographic examinations of the median nerve cross-sectional area will be performed using a LOGIQ P5 (Healthcare Ultrasound, Korea) and a high frequency 7-12 MHz linear probe. A hand dynamometer will be used to assess the grip strength of the hand.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- range of motion exercises, Extracorporeal shock wave therapy, ozone therapy
- Keywords
- Carpal Tunnel Syndrome, ESWT, Ozone therapy
- 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.
range of motion exercisesOther
In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.
Extracorporeal shock wave therapyDevice
Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercises for wrist and hand and splinting.
ozone therapyOther
ozone therapy
| Study group | Role | What they receive |
|---|---|---|
| Ozone therapy group | Experimental | In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week. Receives: Other: range of motion exercises; Other: ozone therapy |
| Extracorporeal shock wave therapy group | Experimental | Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercisess for wrist and hand and splinting. Receives: Other: range of motion exercises; Device: Extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median nerve cross-sectional area
Patients will be positioned seated facing the assessor, with the volar aspect of the wrist facing the air and at rest on a pillow. In the proximal carpal tunnel (at the level of the pisiform bone), the median nerve hyperechoic inner border line will be continuously traced and the transverse section surface area will be measured.
Measured: 2 minutes
Secondary outcomes (1)
Pain assesment
On a 10 cm straight line with values 0 and 10 marked, the patient will be asked to place a mark according to the severity of the hand and/or wrist pain being studied
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469931
- Sponsor's protocol ID
- 2024/06-40
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 24 Jun 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of ESWT and Ozone Therapy in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06469931
- Acronym / sponsor ID
- 2024/06-40
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, ESWT, Ozone therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 24 Jun 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.
ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting.
Detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy resulting from compression of the median nerve at the wrist level. Various methods are applied in the conservative treatment of CTS. These include modification of daily life, splinting, physical therapy modalities and exercise methods. ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Ozone therapy has trophic effects, analgesic effects, antioxidant, immunomodulator, anti-inflammatory and antitumoral effects. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting. Ultrasonographic examinations of the median nerve cross-sectional area will be performed using a LOGIQ P5 (Healthcare Ultrasound, Korea) and a high frequency 7-12 MHz linear probe. A hand dynamometer will be used to assess the grip strength of the hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone therapy group | Experimental | Other: range of motion exercises, Other: ozone therapyIn addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week. |
| Extracorporeal shock wave therapy group | Experimental | Other: range of motion exercises, Device: Extracorporeal shock wave therapyPatients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercisess for wrist and hand and splinting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18-65 who have been complaining for at least 3 months
- Diagnosed with mild or moderate Carpal Tunnel Syndrome
Key exclusion criteria (6 listed)
- Cervical disc herniation or radiculopathy,
- Brachial plexus lesion
- Previous hand or neck surgery
- Pregnancy,
- History of fracture at the wrist level
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 |
|---|---|---|
| range of motion exercisesIn addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week. | Other | Extracorporeal shock wave therapy group, Ozone therapy group |
| Extracorporeal shock wave therapyPatients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercises for wrist and hand and splinting. | Device | Extracorporeal shock wave therapy group |
| ozone therapyozone therapy | Other | Ozone therapy group |
Primary outcome
Median nerve cross-sectional area
Time frame: 2 minutes
Patients will be positioned seated facing the assessor, with the volar aspect of the wrist facing the air and at rest on a pillow. In the proximal carpal tunnel (at the level of the pisiform bone), the median nerve hyperechoic inner border line will be continuously traced and the transverse section surface area will be measured.
1 secondary outcome
Pain assesment
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing range of motion exercises, Extracorporeal shock wave therapy and ozone therapy in people with Carpal Tunnel Syndrome, run by Firat 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jun 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median nerve cross-sectional area (time frame: 2 minutes). 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 24 Jun 2024.