Rheumatoid ArthritisNCT04684693
Effect of Laser Puncture on Rheumatoid Arthritis Patients
A study testing Laser in people with Rheumatoid Arthritis, run by Cairo University at 1 site in Egypt.
Trial summary
Studying the effect of laser puncture on rheumatoid arthritis patients Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2020to 22 Jan 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Meeting the criteria of ACR classification for rheumatoid arthritis
- Meeting the criteria of EULAR classification for rheumatoid arthritis
Who cannot join
- Having malignancy
- Having connective tissue disease
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Studying the effect of laser puncture on rheumatoid arthritis patients
- Conditions
- Rheumatoid Arthritis
- Being tested
- Laser, Control
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Laser puncture and exercise
ControlProcedure or surgery
Exercise
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Experimental | Not described Receives: Device: Laser |
| Control Group | Active comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAQ (Change)
Health Assessment questionnaire
Measured: Pre-intervention, 4 weeks
RAQoL (Change)
Rheumatoid Arthritis Quality of Life
Measured: Pre-intervention, 4 weeks
CRP (Change)
Analysis of serum C-reactive protein
Measured: Pre-intervention, 4 weeks
IL-6 (Change)
Plasma interleukin-6 inflammatory markers
Measured: Pre-intervention, 4 weeks
ATP (Change)
Plasma ATP concentration anti-oxidant marker
Measured: Pre-intervention, 4 weeks
MDA (Change)
plasma malondialdehyde oxidative marker
Measured: Pre-intervention, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start25 Dec 2020
- Primary completion20 Jan 2021 (estimated)
- Study completion22 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Sedky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684693
- Sponsor's protocol ID
- REC/010-2020
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adly AS, Adly AS, Adly MS, Ali MF. A novel approach utilizing laser acupuncture teletherapy for management of elderly-onset rheumatoid arthritis: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):298-306. doi: 10.1177/1357633X211009861. Epub 2021 May 9.
PubMed 33966520
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Puncture on Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT04684693
- Acronym / sponsor ID
- REC/010-2020
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 22 Jan 2021 (estimated)
- First posted
- 24 Dec 2020 (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.
Studying the effect of laser puncture on rheumatoid arthritis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Experimental | Device: Laser |
| Control Group | Active comparator | Procedure: Control |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Meeting the criteria of ACR classification for rheumatoid arthritis
- Meeting the criteria of EULAR classification for rheumatoid arthritis
Key exclusion criteria (3 listed)
- Having malignancy
- Having connective tissue disease
- Smokers
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 |
|---|---|---|
| LaserLaser puncture and exercise | Device | Laser Group |
| ControlExercise | Procedure or surgery | Control Group |
Primary outcome
HAQ (Change)
Time frame: Pre-intervention, 4 weeks
Health Assessment questionnaire
RAQoL (Change)
Time frame: Pre-intervention, 4 weeks
Rheumatoid Arthritis Quality of Life
CRP (Change)
Time frame: Pre-intervention, 4 weeks
Analysis of serum C-reactive protein
IL-6 (Change)
Time frame: Pre-intervention, 4 weeks
Plasma interleukin-6 inflammatory markers
ATP (Change)
Time frame: Pre-intervention, 4 weeks
Plasma ATP concentration anti-oxidant marker
MDA (Change)
Time frame: Pre-intervention, 4 weeks
plasma malondialdehyde oxidative marker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 33966520Adly AS, Adly AS, Adly MS, Ali MF. A novel approach utilizing laser acupuncture teletherapy for management of elderly-onset rheumatoid arthritis: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):298-306. doi: 10.1177/1357633X211009861. Epub 2021 May 9.
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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 Laser in people with Rheumatoid Arthritis, run by Cairo 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 2 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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?
Results are not available in the source record.
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?
HAQ (Change) (time frame: Pre-intervention, 4 weeks). The study lists 6 primary outcomes in all. 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 NCT04684693, which also lists 1 linked publication.
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 5 Jan 2021.