Chronic PainNCT04961281
Dexmedetomidine Versus Triamcinolone Treatment of Carpal Tunnel Syndrome
A study testing Dexmedetomidine and Triamcinolone in people with Chronic Pain and Carpal Tunnel Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Pain, Carpal Tunnel Syndrome
- What is being tested?
- Dexmedetomidine and Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2021to 1 Aug 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients
- complaining of carpal tunnel syndrome of 3 month duration or more
- diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study
Who cannot join
- patient refusal
- infection at the site of intervention
- allergy to utilized drugs
- diabetic
- previous surgery in the site of injection
- previous injection in the targeted site within the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Triamcinolone Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial
Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.
Read the detailed description
Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.
In case of failed conservative oral therapey, local hydro-dessction of the median nerve can be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized to augment the symptoms reliefe.
Dexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects when injected in the perineural area. Upon such discovery, the goal of this study has been built.
- Conditions
- Chronic Pain, Carpal Tunnel Syndrome
- Being tested
- Dexmedetomidine, Triamcinolone
- Medical subject headings
- Chronic Pain, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
injection of Dexmedetomidine ( 10 microgram/kg) + 10 cc saline injection nearby median nerve as hydro-dissection
TriamcinoloneDrug
injection of triamcinolone ( 40 mg) + 10 cc saline injection nearby median nerve as hydro-dissection
| Study group | Role | What they receive |
|---|---|---|
| Dexmeditomidine group | Active comparator | injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection Receives: Drug: Dexmedetomidine |
| triamcinolone group | Active comparator | injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain visual analoge scale
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
Measured: 6 months
Secondary outcomes (1)
change of cross sectional area of the median nerve
change of cross sectional area of the median nerve mm2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start22 Jul 2021
- Primary completion31 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Model description
- Parallel Assignment Investigate if, and to what extent,carapl tunnel hydro-dissection using DEX or triamcinolone (TM) along with saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961281
- Sponsor's protocol ID
- IRB0002021
- Status last verified
- Oct 2022
- First submitted
- 22 Jun 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.
PubMed 12535461Li B, Li Y, Tian S, Wang H, Wu H, Zhang A, Gao C. Anti-inflammatory Effects of Perioperative Dexmedetomidine Administered as an Adjunct to General Anesthesia: A Meta-analysis. Sci Rep. 2015 Jul 21;5:12342. doi: 10.1038/srep12342.
PubMed 26196332Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.
PubMed 18719449Sukegawa S, Higuchi H, Inoue M, Nagatsuka H, Maeda S, Miyawaki T. Locally injected dexmedetomidine inhibits carrageenin-induced inflammatory responses in the injected region. Anesth Analg. 2014 Feb;118(2):473-480. doi: 10.1213/ANE.0000000000000060.
PubMed 24445644Honda Y, Higuchi H, Matsuoka Y, Yabuki-Kawase A, Ishii-Maruhama M, Tomoyasu Y, Maeda S, Morimatsu H, Miyawaki T. The inhibitory effect of locally injected dexmedetomidine on carrageenan-induced nociception in rats. Eur J Pharmacol. 2015 Oct 5;764:215-219. doi: 10.1016/j.ejphar.2015.06.054. Epub 2015 Jul 6.
PubMed 26160316
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Triamcinolone Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04961281
- Acronym / sponsor ID
- IRB0002021
- Conditions
- Chronic Pain, Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 14 Jul 2021 (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 mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.
Detailed description
Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.
In case of failed conservative oral therapey, local hydro-dessction of the median nerve can be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized to augment the symptoms reliefe.
Dexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects when injected in the perineural area. Upon such discovery, the goal of this study has been built.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Investigate if, and to what extent,carapl tunnel hydro-dissection using DEX or triamcinolone (TM) along with saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
| Arm | Type | Receives |
|---|---|---|
| Dexmeditomidine group | Active comparator | Drug: Dexmedetomidineinjection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection |
| triamcinolone group | Active comparator | Drug: Triamcinoloneinjection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adult patients
- complaining of carpal tunnel syndrome of 3 month duration or more
- diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study
Key exclusion criteria (6 listed)
- patient refusal
- infection at the site of intervention
- allergy to utilized drugs
- diabetic
- previous surgery in the site of injection
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 |
|---|---|---|
| Dexmedetomidineinjection of Dexmedetomidine ( 10 microgram/kg) + 10 cc saline injection nearby median nerve as hydro-dissection | Drug | Dexmeditomidine group |
| Triamcinoloneinjection of triamcinolone ( 40 mg) + 10 cc saline injection nearby median nerve as hydro-dissection | Drug | triamcinolone group |
Primary outcome
pain visual analoge scale
Time frame: 6 months
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
1 secondary outcome
change of cross sectional area of the median nerve
Time frame: 6 months
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 Nov 2022.
- Background: PubMed 12535461O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.
- Background: PubMed 26196332Li B, Li Y, Tian S, Wang H, Wu H, Zhang A, Gao C. Anti-inflammatory Effects of Perioperative Dexmedetomidine Administered as an Adjunct to General Anesthesia: A Meta-analysis. Sci Rep. 2015 Jul 21;5:12342. doi: 10.1038/srep12342.
- Background: PubMed 18719449Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.
- Background: PubMed 24445644Sukegawa S, Higuchi H, Inoue M, Nagatsuka H, Maeda S, Miyawaki T. Locally injected dexmedetomidine inhibits carrageenin-induced inflammatory responses in the injected region. Anesth Analg. 2014 Feb;118(2):473-480. doi: 10.1213/ANE.0000000000000060.
- Background: PubMed 26160316Honda Y, Higuchi H, Matsuoka Y, Yabuki-Kawase A, Ishii-Maruhama M, Tomoyasu Y, Maeda S, Morimatsu H, Miyawaki T. The inhibitory effect of locally injected dexmedetomidine on carrageenan-induced nociception in rats. Eur J Pharmacol. 2015 Oct 5;764:215-219. doi: 10.1016/j.ejphar.2015.06.054. Epub 2015 Jul 6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Triamcinolone in people with Chronic Pain and Carpal Tunnel Syndrome, run by Assiut 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 3 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: finished, as of the sponsor's last update on 1 Nov 2022. 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?
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 visual analoge scale (time frame: 6 months). 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 NCT04961281, which also lists 5 linked publications.
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 Nov 2022.