Treatment Resistant Carpal Tunnel in RA PatientsNCT03394131
ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients
A study testing Hylase, Insulin and saline in people with Treatment Resistant Carpal Tunnel in RA Patients, run by Assiut University at 1 site in Egypt.
Trial summary
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection using insulin versus hyalase versus saline, ultrasounic guided as an effective treatment Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Treatment Resistant Carpal Tunnel in RA Patients
- What is being tested?
- Hylase, Insulin and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Aug 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis in remission
Who cannot join
- active Rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Manal Hassanien
Asyut, Assuit, 71111
Manal Hassanien, MD, 01062679200, manal_hassanien@yahoo.com
Abdelraheem Elawamy, MD, 01000032655, arawamyyy@yahoo.com
About this study
Official title: Treatment of Carpal Tunnel in Rheumatoid Arthritis
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection using insulin versus hyalase versus saline, ultrasounic guided as an effective treatment
Read the detailed description
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection of median nerve inside CT twice injections with interval 2 weeks using insulin and 10 cc saline versus hyalase and 10 cc saline versus 10 cc saline, ultrasounic guided as an effective treatment of CT
- Being tested
- Hylase, Insulin, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HylaseDrug
Also called Hyaluronidase
hydro-dissection injection of median nerve inside carpal tunnel using hyalase and 10 cc saline
InsulinDrug
Also called crystalline insulin
hydro-dissection injection of median nerve inside carpal tunnel using 10 IU insulin and 10 cc saline
salineOther
Also called normal saline
hydro-dissection injection of median nerve inside carpal tunnel using 10 cc saline
| Study group | Role | What they receive |
|---|---|---|
| Hyalase | Experimental | injection and hydro-dissection of median nerve using hyaluronidase followed by 10 cc normal saline ultrasonic guided Receives: Drug: Hylase |
| Placebo | Placebo comparator | injection and hydro-dissection of median nerve hydro-dissection using 10 cc saline injection ultrasonic guided Receives: Other: saline |
| Insilin | Active comparator | injection and hydro-dissection of median nerve hydro-dissection using 10 IU insuline followed by 10 cc normal saline ultrasonic guided Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Visual analog scale 0-100
Measured: 6 months
Secondary outcomes (2)
nerve conduction
sensory velocity
Measured: 6 months
ultrasound
cross sectional area
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 posted9 Jan 2018
- Study start1 Jul 2017
- Primary completion1 May 2018
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Carpal Tunnel in RA PatientsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
- Investigators
- Manal Hassanien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394131
- Sponsor's protocol ID
- Hydrodissection of CT in RA
- Status last verified
- Jul 2018
- First submitted
- 25 Dec 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after complete recruiting of patients
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Carpal Tunnel in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03394131
- Acronym / sponsor ID
- Hydrodissection of CT in RA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 9 Jan 2018 (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 peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection using insulin versus hyalase versus saline, ultrasounic guided as an effective treatment
Detailed description
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection of median nerve inside CT twice injections with interval 2 weeks using insulin and 10 cc saline versus hyalase and 10 cc saline versus 10 cc saline, ultrasounic guided as an effective treatment of CT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyalase | Experimental | Drug: Hylaseinjection and hydro-dissection of median nerve using hyaluronidase followed by 10 cc normal saline ultrasonic guided |
| Placebo | Placebo comparator | Other: salineinjection and hydro-dissection of median nerve hydro-dissection using 10 cc saline injection ultrasonic guided |
| Insilin | Active comparator | Drug: Insulininjection and hydro-dissection of median nerve hydro-dissection using 10 IU insuline followed by 10 cc normal saline ultrasonic guided |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid arthritis in remission
Key exclusion criteria (1 listed)
- active Rheumatoid arthritis
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 |
|---|---|---|
| HylaseAlso: Hyaluronidasehydro-dissection injection of median nerve inside carpal tunnel using hyalase and 10 cc saline | Drug | Hyalase |
| InsulinAlso: crystalline insulinhydro-dissection injection of median nerve inside carpal tunnel using 10 IU insulin and 10 cc saline | Drug | Insilin |
| salineAlso: normal salinehydro-dissection injection of median nerve inside carpal tunnel using 10 cc saline | Other | Placebo |
Primary outcome
pain intensity
Time frame: 6 months
Visual analog scale 0-100
2 secondary outcomes
nerve conduction
Time frame: 6 months
ultrasound
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: Yes. after complete recruiting of patients
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.
Manal Hassanien, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hylase, Insulin and saline in people with Treatment Resistant Carpal Tunnel in RA Patients, 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 1 inclusion and 1 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 13 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
Contact Manal Hassanien, MD (01062679200, manal_hassanien@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: 6 months). 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 13 Jul 2018.