Carpal TunnelNCT06133712
Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief
A study testing Dexmedetomidine, Ozone and Dexamethasone in people with Carpal Tunnel and Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Carpal Tunnel, Dexmedetomidine, Ozone
- What is being tested?
- Dexmedetomidine, Ozone and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 60 years.
- Both sexes.
- Patients with ultrasonographic evidence of mild-to-moderate carpal tunnel syndrome (CTS).
- Inclusion criteria will include numbness and pain in the median nerve (MN) distribution persisting for minimum of 3 months , nerve conduction studies (NCS) consistent with carpal tunnel syndrome (CTS) as per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines, and an median nerve (MN) cross-sectional area (CSA)at the wrist >12 mm2 suggesting mild-to-moderate CTS forms.
Who cannot join
- Patient refusal.
- Patients with severe symptoms and signs of CTS as identified per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines,[14] as this is an indication for surgery,
- Patients who show improvement on medical treatment,
- Previous surgical or injectional CTS treatment,
- Pregnancy ,co existence of brachial plexopathy, or thoracic outlet syndrome, polyneuropathy, radiculopathy and peripheral nerve lesion in upper limb.
- Severe cardiovascular disease
Show all 14Show fewer
- Morbid obese patients (body mass index (BMI) of >35 kg/m2)
- Infection at site of injection.
- Bleeding diathesis.
- History of thyroid deficiency, uncontrolled diabetes mellitus , rheumatoid arthritis and history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- History of Ozone or Dexmedetomidine allergy.
- End stage renal and hepatic disease.
- History of inflammatory joint , connective tissue disorders, , burns, any local tissue contractures and history of wrist trauma.
- Patients who will not consent to completing The visual analogue scale (VAS) for pain or nerve conduction study before and after injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Tanta, El Gharbia, 31527
Mahmoud Elgebaly, MD, 00201092415231, mahmoud.talaat@med.tanta.edu
Mahmoud Elgebaly, MD, 00201006145708, mahmoudelgebaly75@gmail.com
About this study
Official title: A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief
The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.
Read the detailed description
Carpal tunnel syndrome (CTS) is a collection of symptoms and signs associated with median neuropathy at the carpal tunnel. Most CTS is related to idiopathic compression of the median nerve as it travels through the wrist at the carpal tunnel.
Corticosteroid injection is an extensively used and accepted treatment in mild to moderate CTS according to the guidelines of the American Academy of Orthopedic Surgeons as corticosteroids reduce the inflammation and edema associated with CTS. However, there is no guideline as to which corticosteroid has to be used as the standard treatment in CTS.
Triamcinolone acetonide, a commonly used steroid for this indication, is a particulate steroid, which can cause permanent nerve injury if accidentally injected into the nerve.
Local ozone injection as a therapeutic option in some musculoskeletal conditions; ozone (O3) gas is a molecule consisting of three oxygen atoms in a dynamically unstable structure. Ozone therapy has been utilized and studied for more than a century.
- Conditions
- Carpal Tunnel, Dexmedetomidine, Ozone, Dexamethasone
- Being tested
- Dexmedetomidine, Ozone, Dexamethasone
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex®
Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve.
OzoneDrug
Also called PubChem CID 24823
Participants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle.
DexamethasoneDrug
Also called Decadron
Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL [8 mg] dexamethasone) via the same technique.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve Receives: Drug: Dexmedetomidine |
| Ozone | Active comparator | Participants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle. Receives: Drug: Ozone |
| Dexamethasone | Active comparator | Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL [8 mg] dexamethasone) via the same technique. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome
The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome via assessment of Visual Analogue Scale (VAS) before and after injection.
VAS used as an effective tool to detect intensity of pain will be recorded (0 to10) "0" represents no pain ,"10" worst pain, "1-3" mild pain,"4-6 " moderate pain and" 7-10 " severe pain.
Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24 weeks intervals after injection.
Measured: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Secondary outcomes (3)
Median motor nerve conduction study(NCS) evaluation
Each patient will be assessed regarding electrophysiological changes sensory nerve conduction velocity in millimeter/seconds and distal motor latency in milliseconds at the baseline (before injection), at 1week, 4weeks, 12 weeks and 24 weeks intervals after injection.
Measured: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Sensory nerve conduction study(NCS) evaluation
Each patient will be assessed regarding electrophysiological changes sensory nerve conduction velocity in millimeter/seconds and distal motor latency in milliseconds at the baseline (before injection), at 1week, 4weeks, 12weeks, and 24 weeks intervals after injection.
Measured: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Analgesic requirement
Analgesic requirement ( dose and frequency of oral acetaminophen intake in first 48 hours) for post injection .
Measured: First 48 hours post injection .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal TunnelStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud T Elgebaly,MD, Tanta University
- Investigators
- MAHMOUD ELGEBALY, MD, Principal investigator, Tanta faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133712
- Sponsor's protocol ID
- 36226/12/22
- Status last verified
- May 2025
- First submitted
- 2 Nov 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief
- ClinicalTrials.gov ID
- NCT06133712
- Acronym / sponsor ID
- 36226/12/22
- Conditions
- Carpal Tunnel, Dexmedetomidine, Ozone, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.
Detailed description
Carpal tunnel syndrome (CTS) is a collection of symptoms and signs associated with median neuropathy at the carpal tunnel. Most CTS is related to idiopathic compression of the median nerve as it travels through the wrist at the carpal tunnel.
Corticosteroid injection is an extensively used and accepted treatment in mild to moderate CTS according to the guidelines of the American Academy of Orthopedic Surgeons as corticosteroids reduce the inflammation and edema associated with CTS. However, there is no guideline as to which corticosteroid has to be used as the standard treatment in CTS.
Triamcinolone acetonide, a commonly used steroid for this indication, is a particulate steroid, which can cause permanent nerve injury if accidentally injected into the nerve.
Local ozone injection as a therapeutic option in some musculoskeletal conditions; ozone (O3) gas is a molecule consisting of three oxygen atoms in a dynamically unstable structure. Ozone therapy has been utilized and studied for more than a century.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidinePatients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve |
| Ozone | Active comparator | Drug: OzoneParticipants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle. |
| Dexamethasone | Active comparator | Drug: DexamethasonePatients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL [8 mg] dexamethasone) via the same technique. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 20 to 60 years.
- Both sexes.
- Patients with ultrasonographic evidence of mild-to-moderate carpal tunnel syndrome (CTS).
- Inclusion criteria will include numbness and pain in the median nerve (MN) distribution persisting for minimum of 3 months , nerve conduction studies (NCS) consistent with carpal tunnel syndrome (CTS) as per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines, and an median nerve (MN) cross-sectional area (CSA)at the wrist >12 mm2 suggesting mild-to-moderate CTS forms.
Key exclusion criteria (14 listed)
- Patient refusal.
- Patients with severe symptoms and signs of CTS as identified per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines,[14] as this is an indication for surgery,
- Patients who show improvement on medical treatment,
- Previous surgical or injectional CTS treatment,
- Pregnancy ,co existence of brachial plexopathy, or thoracic outlet syndrome, polyneuropathy, radiculopathy and peripheral nerve lesion in upper limb.
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex®Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve. | Drug | Dexmedetomidine |
| OzoneAlso: PubChem CID 24823Participants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle. | Drug | Ozone |
| DexamethasoneAlso: DecadronPatients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL [8 mg] dexamethasone) via the same technique. | Drug | Dexamethasone |
Primary outcome
The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome
Time frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome via assessment of Visual Analogue Scale (VAS) before and after injection. VAS used as an effective tool to detect intensity of pain will be recorded (0 to10) "0" represents no pain ,"10" worst pain, "1-3" mild pain,"4-6 " moderate pain and" 7-10 " severe pain. Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24 weeks intervals after injection.
3 secondary outcomes
Median motor nerve conduction study(NCS) evaluation
Time frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Sensory nerve conduction study(NCS) evaluation
Time frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Analgesic requirement
Time frame: First 48 hours post injection .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Carpal Tunnel
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.
MAHMOUD ELGEBALY, MD principal investigator
Tanta faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Ozone and Dexamethasone in people with Carpal Tunnel and Dexmedetomidine, run by Tanta University at 1 site in Egypt.
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 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: looking for participants now, as of the sponsor's last update on 29 May 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud T Elgebaly, MD (00201092415231, mahmoud.talaat@med.tanta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome (time frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date). 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 29 May 2025.