Carpal Tunnel SyndromeNCT06237634
Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome
A study testing splint and exercise and advices, Triamsinolon Asetonid ozone and ozone in people with Carpal Tunnel Syndrome, run by Kayseri City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
There are a limited number of studies on the use of ozone in CTS.The aim of this clinical study is to compare the effectiveness of corticosteroid injections and ozone injections added to splint and exercise therapy in mild-moderate CTS patients.. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- splint and exercise and advices, Triamsinolon Asetonid ozone and ozone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 Sep 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-70, male or female.
- Clinically and electrophysiologically diagnosed with mild or moderate CTS
- Having symptoms for 1 month or longer
- No contraindications for corticosteroid and ozone application
- Patients whose consent was obtained to participate in the study
Who cannot join
- Under 18 years old and over 70 years old
- Having a severe CTS
- Having thenar atrophy
- Those with diabetes, thyroid and kidney disease and CTS developing secondary to this
- Those with previous traumatic nerve injury, peripheral nerve injury or surgery
- Those with a diagnosis of polyneuropathy
Show all 14Show fewer
- Having rheumatic disease
- With known radiculopathy
- are pregnant
- Known G6PD deficiency, hyperthyroidism, thrombocytopenia, severe cardiovascular instability
- Those who have infection, burns, cuts or skin integrity in the skin area to be treated
- Cognitive disorder, severe psychiatric illness
- Those with diabetes, thyroid and kidney disease and CTS developing secondary to this
- Patients who have not received corticosteroid or ozone injection in the last 3 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
health sciences university Kayseri medicine faculty
Kayseri, 38080
Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Kayseri, 38080
About this study
Official title: Comparison Of The Effectiveness Of Ultrasound Acrossed Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome
There are a limited number of studies on the use of ozone in CTS.The aim of this clinical study is to compare the effectiveness of corticosteroid injections and ozone injections added to splint and exercise therapy in mild-moderate CTS patients..
106 patients included in the study were randomized and divided into three groups. During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.
Read the detailed description
106 patients included in the study were randomized and divided into three groups.
During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.
Neutral hand-wrist rest splint and tendon-nerve gliding exercises were given to 30 patients included in the control group.
In addition to the treatment given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected under USG guidance to 30 patients included in the corticosteroid group.
In addition to splint and exercise therapy, 3 cc ozone (O2-O3), 10 micrograms were injected under USG guidance to 30 patients in the ozone group.
Patients in all three groups were evaluated at the beginning of treatment, 6 weeks and 3 months after treatment.
Evaluation methods include provocative tests (Tinnel, Phallen, Flick tests), visual analogue scale (VAS) numbness day/night and VAS pain scores, sensory tests (two-point discrimination and Semmes Weinstein monofilament test (SWMT)), hand and finger grip strengths. measurement, Boston carpal tunnel syndrome questionnaire (BCTA), median nerve cross-sectional area (MSCA) measurement with USG and electrophysiological parameters were used.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- splint and exercise and advices, Triamsinolon Asetonid ozone, ozone
- Keywords
- ozone injection, corticosteroid injection, carpal tunnel sendromu, ultrasound guided injection
- 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.
splint and exercise and advicesOther
A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.
Triamsinolon Asetonid ozoneOther
40 mg (1 ml) of triamcinolone acetonide was injected to the median nerve's around at wrist level under ultrasound guidance.
ozoneOther
In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | First group (30 people): A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.. Receives: Other: splint and exercise and advices |
| corticosteroid group | Active comparator | Second group (30 people): In addition to the treatment and recommendations given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected into the wrist under ultrasound guidance. Receives: Other: splint and exercise and advices; Other: Triamsinolon Asetonid ozone |
| ozone group | Experimental | Third group (30 people): In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml. Receives: Other: splint and exercise and advices; Other: ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire
The BCTQ comprises two subscales. The Symptom Severity Scale yields PRO data on the level of symptoms, while the Functional Status Scale assesses the level of hand function. The Symptom Severity Scale consists of 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms, and difficulty of grasping. The Functional Status Scale contains eight items, which assess functional deficits in the following domains: writing, buttoning clothes, holding a book while reading, gripping a telephone handle, opening jars, performing household chores, carrying grocery bags, bathing and dressing. Each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function. A Finnish version of the BCTQ, which was used in this study, has been previously validated
Measured: at baseline, week 6, week 12
Secondary outcomes (3)
VAS
Visual analog scale A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: at baseline, week 6, week 12
ultrasound measurements
median nerve diameter measurement
Measured: at baseline, week 6, week 12
EMG measurements
median nerve latancy,amplitud, velocity measurements
Measured: at baseline, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jan 2021
- Primary completion10 Apr 2021
- Study completion15 Sep 2021
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Calıs, Kayseri City Hospital
- Investigators
- HAVVA TALAY CALIS, PROF. DR, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237634
- Sponsor's protocol ID
- Kayseri CH
- Status last verified
- Jan 2024
- First submitted
- 8 Aug 2023
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effectiveness Of Ultrasound Acrossed Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06237634
- Acronym / sponsor ID
- Kayseri CH
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- ozone injection, corticosteroid injection, carpal tunnel sendromu, ultrasound guided injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 1 Feb 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.
There are a limited number of studies on the use of ozone in CTS.The aim of this clinical study is to compare the effectiveness of corticosteroid injections and ozone injections added to splint and exercise therapy in mild-moderate CTS patients..
106 patients included in the study were randomized and divided into three groups. During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.
Detailed description
106 patients included in the study were randomized and divided into three groups.
During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.
Neutral hand-wrist rest splint and tendon-nerve gliding exercises were given to 30 patients included in the control group.
In addition to the treatment given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected under USG guidance to 30 patients included in the corticosteroid group.
In addition to splint and exercise therapy, 3 cc ozone (O2-O3), 10 micrograms were injected under USG guidance to 30 patients in the ozone group.
Patients in all three groups were evaluated at the beginning of treatment, 6 weeks and 3 months after treatment.
Evaluation methods include provocative tests (Tinnel, Phallen, Flick tests), visual analogue scale (VAS) numbness day/night and VAS pain scores, sensory tests (two-point discrimination and Semmes Weinstein monofilament test (SWMT)), hand and finger grip strengths. measurement, Boston carpal tunnel syndrome questionnaire (BCTA), median nerve cross-sectional area (MSCA) measurement with USG and electrophysiological parameters were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: splint and exercise and advicesFirst group (30 people): A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.. |
| corticosteroid group | Active comparator | Other: splint and exercise and advices, Other: Triamsinolon Asetonid ozoneSecond group (30 people): In addition to the treatment and recommendations given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected into the wrist under ultrasound guidance. |
| ozone group | Experimental | Other: splint and exercise and advices, Other: ozoneThird group (30 people): In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 18-70, male or female.
- Clinically and electrophysiologically diagnosed with mild or moderate CTS
- Having symptoms for 1 month or longer
- No contraindications for corticosteroid and ozone application
- Patients whose consent was obtained to participate in the study
Key exclusion criteria (14 listed)
- Under 18 years old and over 70 years old
- Having a severe CTS
- Having thenar atrophy
- Those with diabetes, thyroid and kidney disease and CTS developing secondary to this
- Those with previous traumatic nerve injury, peripheral nerve injury or surgery
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 |
|---|---|---|
| splint and exercise and advicesA hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side. | Other | control group, corticosteroid group, ozone group |
| Triamsinolon Asetonid ozone40 mg (1 ml) of triamcinolone acetonide was injected to the median nerve's around at wrist level under ultrasound guidance. | Other | corticosteroid group |
| ozoneIn addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml. | Other | ozone group |
Primary outcome
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: at baseline, week 6, week 12
The BCTQ comprises two subscales. The Symptom Severity Scale yields PRO data on the level of symptoms, while the Functional Status Scale assesses the level of hand function. The Symptom Severity Scale consists of 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms, and difficulty of grasping. The Functional Status Scale contains eight items, which assess functional deficits in the following domains: writing, buttoning clothes, holding a book while reading, gripping a telephone handle, opening jars, performing household chores, carrying grocery bags, bathing and dressing. Each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function. A Finnish version of the BCTQ, which was used in this study, has been previously validated
3 secondary outcomes
VAS
Time frame: at baseline, week 6, week 12
ultrasound measurements
Time frame: at baseline, week 6, week 12
EMG measurements
Time frame: at baseline, week 6, week 12
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 1 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for 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.
HAVVA TALAY CALIS, PROF. DR principal investigator
Kayseri City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing splint and exercise and advices, Triamsinolon Asetonid ozone and ozone in people with Carpal Tunnel Syndrome, run by Kayseri City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Boston Carpal Tunnel Syndrome Questionnaire (time frame: at baseline, week 6, week 12). 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 1 Feb 2024.