Rheumatoid ArthritisNCT04758689
Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients
A study testing Laser, exercise, and methotrexate and Exercise, and methotrexate in people with Rheumatoid Arthritis, run by Cairo University at 1 site in Egypt.
Trial summary
Studying the effect of laser acupuncture on geriatric patients with rheumatoid arthritis 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, exercise, and methotrexate and Exercise, and methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 22 Dec 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients referred from physician (immunologist) diagnosed with rheumatoid arthritis.
Who cannot join
- Patients having the disease overlapping with other connective tissue diseases, such as systematic lupus erythromatosus and systematic sclerosis.
- History of malignancies.
Trial locations and contacts
1 site in 1 country.
About this study
Studying the effect of laser acupuncture on geriatric patients with rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis
- Being tested
- Laser, exercise, and methotrexate, Exercise, and methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser, exercise, and methotrexateCombination product
Laser therapy at acupuncture points, aerobic exercise, and methotrexate
Exercise, and methotrexateCombination product
Aerobic exercise, and methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture and aerobic exercise | Experimental | Not described Receives: Combination Product: Laser, exercise, and methotrexate |
| Aerobic exercise | Experimental | Not described Receives: Combination Product: Exercise, and methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 6 (IL-6)
interleukin 6
Measured: Baseline
Interleukin 6 (IL-6)
interleukin 6
Measured: 4 weeks
Malondialdehyde (MDA)
malondialdehyde
Measured: Baseline
Malondialdehyde (MDA)
malondialdehyde
Measured: 4 weeks
Adenosine Triphosphate (ATP)
adenosine triphosphate
Measured: Baseline
Adenosine Triphosphate (ATP)
adenosine triphosphate
Measured: 4 weeks
C-Reactive Protein (CRP)
C-reactive protein
Measured: Baseline
C-Reactive Protein (CRP)
C-reactive protein
Measured: 4 weeks
Secondary outcomes (4)
Rheumatoid Arthritis Quality of Life (RAQoL)
rheumatoid arthritis quality of life
Measured: Baseline
Rheumatoid Arthritis Quality of Life (RAQoL)
rheumatoid arthritis quality of life
Measured: 4 weeks
Health Assessment Questionnaire (HAQ)
health assessment questionnaire
Measured: Baseline
Health Assessment Questionnaire (HAQ)
health assessment questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start20 Nov 2020
- Primary completion20 Dec 2020
- Study completion22 Dec 2020
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
- NCT04758689
- Sponsor's protocol ID
- REC/002-2021
- Status last verified
- May 2021
- First submitted
- 11 Feb 2021
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adly AS, Adly AS, Adly MS. Effects of laser acupuncture tele-therapy for rheumatoid arthritis elderly patients. Lasers Med Sci. 2022 Feb;37(1):499-504. doi: 10.1007/s10103-021-03287-0. Epub 2021 Mar 19.
PubMed 33738615
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients
- ClinicalTrials.gov ID
- NCT04758689
- Acronym / sponsor ID
- REC/002-2021
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 17 Feb 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.
Studying the effect of laser acupuncture on geriatric patients with rheumatoid arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture and aerobic exercise | Experimental | Combination Product: Laser, exercise, and methotrexate |
| Aerobic exercise | Experimental | Combination Product: Exercise, and methotrexate |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients referred from physician (immunologist) diagnosed with rheumatoid arthritis.
Key exclusion criteria (2 listed)
- Patients having the disease overlapping with other connective tissue diseases, such as systematic lupus erythromatosus and systematic sclerosis.
- History of malignancies.
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 |
|---|---|---|
| Laser, exercise, and methotrexateLaser therapy at acupuncture points, aerobic exercise, and methotrexate | Combination product | Laser acupuncture and aerobic exercise |
| Exercise, and methotrexateAerobic exercise, and methotrexate | Combination product | Aerobic exercise |
Primary outcome
Interleukin 6 (IL-6)
Time frame: Baseline
interleukin 6
Interleukin 6 (IL-6)
Time frame: 4 weeks
interleukin 6
Malondialdehyde (MDA)
Time frame: Baseline
malondialdehyde
Malondialdehyde (MDA)
Time frame: 4 weeks
malondialdehyde
Adenosine Triphosphate (ATP)
Time frame: Baseline
adenosine triphosphate
Adenosine Triphosphate (ATP)
Time frame: 4 weeks
adenosine triphosphate
C-Reactive Protein (CRP)
Time frame: Baseline
C-reactive protein
C-Reactive Protein (CRP)
Time frame: 4 weeks
C-reactive protein
4 secondary outcomes
Rheumatoid Arthritis Quality of Life (RAQoL)
Time frame: Baseline
Rheumatoid Arthritis Quality of Life (RAQoL)
Time frame: 4 weeks
Health Assessment Questionnaire (HAQ)
Time frame: Baseline
Health Assessment Questionnaire (HAQ)
Time frame: 4 weeks
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 6 May 2021.
- Derived from this study: PubMed 33738615Adly AS, Adly AS, Adly MS. Effects of laser acupuncture tele-therapy for rheumatoid arthritis elderly patients. Lasers Med Sci. 2022 Feb;37(1):499-504. doi: 10.1007/s10103-021-03287-0. Epub 2021 Mar 19.
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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, exercise, and methotrexate and Exercise, and methotrexate 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 1 inclusion and 2 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 6 May 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?
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?
Interleukin 6 (IL-6) (time frame: Baseline). The study lists 8 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 NCT04758689, 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 6 May 2021.