Laser StimulationELAROPNCT03757871
Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
A study testing Laser stimulation in people with Laser Stimulation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Read more about this study
- Who is it for?
- Ages 23 to 31 weeks
- Conditions the study is for
- Laser Stimulation
- What is being tested?
- Laser stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2019to 1 Mar 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 23 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP screening;
- Premature birth weights < 1250g with a 1st FO for ROP screening;
- Informed consent of the holder(s) of parental authority;
- Child benefiting from a social security system
Who cannot join
- Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.
- Known chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective.
Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.
Read the detailed description
Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the G30% glucose solution 2 minutes before the examination associated with the instillation of a drop of oxybuprocaine administered 1 minute before the start of the examination on pain assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP) measured before the start of the examination (baseline) and on 30 seconds after the examination of both eyes.
- Conditions
- Laser Stimulation
- Being tested
- Laser stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser stimulationDevice
an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Laser Stimulation | Experimental | laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point. Receives: Device: Laser stimulation |
| Placebo | Placebo comparator | The placebo group will have an application of the pen according to the same extinguished laser criteria. Receives: Device: Laser stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
score at PIPP (premature infant pain profile) ≥ 10
Measurement of pain or discomfort defined by a PIPP score ≥ 10
Measured: 24 hours
Secondary outcomes (2)
pain and discomfort
Assess pain and discomfort (score FANS). The FANS score is a validated hetero-rating scale for assessing acute newborn pain when the face is difficult to analyse. On the 0 to 10 side, the absence of pain is defined by a score < 3
Measured: 24 hours
heart rate variability
assessment of heart rate variability (NIPE score)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start26 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser StimulationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farnoux Caroline, PHD, Principal investigator, APHPBiran Valerie, PHD, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757871
- Sponsor's protocol ID
- P171005J
- Acronym
- ELAROP
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2018
- Last updated
- 29 Apr 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 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
- ClinicalTrials.gov ID
- NCT03757871
- Acronym / sponsor ID
- ELAROP / P171005J
- Conditions
- Laser Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 29 Nov 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.
Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective.
Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.
Detailed description
Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the G30% glucose solution 2 minutes before the examination associated with the instillation of a drop of oxybuprocaine administered 1 minute before the start of the examination on pain assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP) measured before the start of the examination (baseline) and on 30 seconds after the examination of both eyes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Stimulation | Experimental | Device: Laser stimulationlaser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point. |
| Placebo | Placebo comparator | Device: Laser stimulationThe placebo group will have an application of the pen according to the same extinguished laser criteria. |
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP screening;
- Premature birth weights < 1250g with a 1st FO for ROP screening;
- Informed consent of the holder(s) of parental authority;
- Child benefiting from a social security system
Key exclusion criteria (2 listed)
- Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.
- Known chromosomal abnormality
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 stimulationan acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes. | Device | Laser Stimulation, Placebo |
Primary outcome
score at PIPP (premature infant pain profile) ≥ 10
Time frame: 24 hours
Measurement of pain or discomfort defined by a PIPP score ≥ 10
2 secondary outcomes
pain and discomfort
Time frame: 24 hours
heart rate variability
Time frame: 24 hours
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 29 Apr 2020.
Related trials for Laser Stimulation
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
Myofacial Pain Syndrome
RecruitingPhase 1/2
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
Depression - Major Depressive Disorder
RecruitingObservational study
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
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.
Farnoux Caroline, PHD principal investigator
APHP
Biran Valerie, PHD study chair
APHP
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 stimulation in people with Laser Stimulation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 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 29 Apr 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 France. 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?
score at PIPP (premature infant pain profile) ≥ 10 (time frame: 24 hours). 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 29 Apr 2020.