Rheumatoid ArthritisNCT04130178
Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study
A study testing Nerve block and Saline injection in people with Rheumatoid Arthritis, run by Sohag University at 1 site in Egypt.
Trial summary
Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Nerve block and Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2019to 25 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis patient according to ACR/EULAR criteria
- age >18
- bilateral hand affection
Who cannot join
- peripheral neuropathy
- other chronic arthritis
- patient who did mastectomy or any other hand operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study
Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). The other hand will be used as a control and injected subcutaneously with saline. Half ml of Bupivacaine will be injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP. The needle will be directed alternatively toward the two pedicles on both sides.
PIPs of the 2nd and 3rd fingers in both hands will be examined EULAR-OMERACT scoring system at 0, 2 weeks, and 2 months intervals. Visual analog scale (VAS) for each hand will be used at the same intervals. There are no certain conditions for medications and all the patients were using sDMARDS.
Read the detailed description
PIPs of the 2nd and 3rd fingers at the control group will be injected with .5 mL of saline on each joint through a 27G needle.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Nerve block, Saline injection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockDrug
block of the digital nerves in rheumatoid arthritis patient
Saline injectionDrug
subcutaneous saline injection
| Study group | Role | What they receive |
|---|---|---|
| Bupivacine injected | Active comparator | Half ml of Bupivicaine hydrochloride .5% (Marcaine, Pfizer) was injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP on each side of the selected joint. Receives: Drug: Nerve block |
| Control group | Placebo comparator | Saline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint. Receives: Drug: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
by visual analogue sclae
Measured: 0 time after 2 weeks and after 2 months
Change in the degree of inflammation
Musculoskeletal ultrasound evaluation by EULAR-OMERACT score
Measured: at 0 time after 2 weeks and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start15 Oct 2019
- Primary completion25 Jan 2020
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahrous, Sohag University
- Investigators
- Ahmed Elsaman, PhD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130178
- Sponsor's protocol ID
- 4/10/2019
- Status last verified
- Dec 2020
- First submitted
- 11 Oct 2019
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04130178
- Acronym / sponsor ID
- 4/10/2019
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 17 Oct 2019 (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.
Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). The other hand will be used as a control and injected subcutaneously with saline. Half ml of Bupivacaine will be injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP. The needle will be directed alternatively toward the two pedicles on both sides.
PIPs of the 2nd and 3rd fingers in both hands will be examined EULAR-OMERACT scoring system at 0, 2 weeks, and 2 months intervals. Visual analog scale (VAS) for each hand will be used at the same intervals. There are no certain conditions for medications and all the patients were using sDMARDS.
Detailed description
PIPs of the 2nd and 3rd fingers at the control group will be injected with .5 mL of saline on each joint through a 27G needle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacine injected | Active comparator | Drug: Nerve blockHalf ml of Bupivicaine hydrochloride .5% (Marcaine, Pfizer) was injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP on each side of the selected joint. |
| Control group | Placebo comparator | Drug: Saline injectionSaline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rheumatoid arthritis patient according to ACR/EULAR criteria
- age >18
- bilateral hand affection
Key exclusion criteria (3 listed)
- peripheral neuropathy
- other chronic arthritis
- patient who did mastectomy or any other hand operation
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 |
|---|---|---|
| Nerve blockblock of the digital nerves in rheumatoid arthritis patient | Drug | Bupivacine injected |
| Saline injectionsubcutaneous saline injection | Drug | Control group |
Primary outcome
Change in pain
Time frame: 0 time after 2 weeks and after 2 months
by visual analogue sclae
Change in the degree of inflammation
Time frame: at 0 time after 2 weeks and after 2 months
Musculoskeletal ultrasound evaluation by EULAR-OMERACT score
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 28 Dec 2020.
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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.
Ahmed Elsaman, PhD principal investigator
Sohag 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 Nerve block and Saline injection in people with Rheumatoid Arthritis, run by Sohag 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 3 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 28 Dec 2020. 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?
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?
Change in pain (time frame: 0 time after 2 weeks and after 2 months). The study lists 2 primary outcomes in all. 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 28 Dec 2020.