Laser AcupunctureNCT06342791
Effect of Laser Acupuncture on Menstrual Back Pain
A study testing laser acupuncture in people with Laser Acupuncture and Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
effect of laser acupuncture on menstrual back pain Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Laser Acupuncture, Low Back Pain, Menstruation
- What is being tested?
- laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to 20 Jun 2024
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All females will have low back pain during menstruation
- Age of the patients will range from 20-30 years.
- Their BMI will be range from 20-30 kg/ m 2
Who cannot join
- - Psychiatric disorders
- Pelvic floor dysfunction
- Lumber disc prolapse or any Previous surgery on spine.
- Tumor in lumbar spine
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy cairo university
Cairo, 37617692
Mai Ali Galal El sayed, 01152457470, Princessmai828@gmail.com
About this study
effect of laser acupuncture on menstrual back pain
Read the detailed description
The aim of this study is to determine the effect of laser acupuncture on the points BL23, BL26, BL40 and SP6 in relieving menstrual back pain.
- Conditions
- Laser Acupuncture, Low Back Pain, Menstruation
- Being tested
- laser acupuncture
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureDevice
laser use to stimulate acupuncture points
| Study group | Role | What they receive |
|---|---|---|
| Group A (study group) | Experimental | received Laser on acupuncture point BL23, BL26, BL40, SP6 Receives: Device: laser acupuncture |
| Group B (Control group) | Placebo comparator | received sham laser acupuncture on BL23, BL26, BL40, SP6 but the laser was not turned on Receives: Device: laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
back Pain intensity during menstruation
It will be assess by Visual analogue scale(VAS). VAS used to indicate the level of pain intensity from 1 to 10, before starting treatment (first record) then after treatment (as second record). A visual analogue scale's (VAS) baseline typically falls at one end of the scale and is frequently denoted by the numbers "no pain" or "0," which indicate for the absence of the sensation being assessed. The other end of the line indicates "worst pain imaginable" or a high numerical value, such as 10
Measured: before 3 month from begining of treatment
pain threshold
Using algometer to measure pain threshold. Before beginning the measurement, a pressure algometer's baseline is usually set at zero pressure. This means that the initial pressure applied by the algometer is zero, and then the pressure is gradually increased until the individual being tested starts to feel pain or discomfort. This baseline helps to establish a reference point for measuring pain thresholds or sensitivity to pressure
Measured: Before 3 month from begining of the treatment
Ability to perform daily activities
Ability to perform daily activities will be assess by using Instrumental activities of daily living (IADL).This scale has been designed to give information about how back pain has affected the ability to manage everyday life. IADLs are scored based on what an individual can do rather than what she is doing. Ask patient to answer every section and mark in each section only the one box which most closely describes the condition at this time. There are 22 questions and rate them on the scale at right. The higher scores mean a better.
Measured: Before 3 month from begining of the treatment
Secondary outcomes (3)
back Pain intensity during menstruation
It will be assess by Visual analogue scale(VAS). VAS used to indicate the level of pain intensity from 1 to 10, before starting treatment (first record) then after treatment (as second record). A visual analogue scale's (VAS) baseline typically falls at one end of the scale and is frequently denoted by the numbers "no pain" or "0," which indicate for the absence of the sensation being assessed. The other end of the line indicates "worst pain imaginable" or a high numerical value, such as 10
Measured: 3 month after treatment
pain threshold
Using algometer to measure pain threshold. Before beginning the measurement, a pressure algometer's baseline is usually set at zero pressure. This means that the initial pressure applied by the algometer is zero, and then the pressure is gradually increased until the individual being tested starts to feel pain or discomfort. This baseline helps to establish a reference point for measuring pain thresholds or sensitivity to pressure
Measured: 3 month after treatment
Ability to perform daily activities
Ability to perform daily activities will be assess by using Instrumental activities of daily living (IADL).This scale has been designed to give information about how back pain has affected the ability to manage everyday life. IADLs are scored based on what an individual can do rather than what she is doing. Ask patient to answer every section and mark in each section only the one box which most closely describes the condition at this time. There are 22 questions and rate them on the scale at right. The higher scores mean a better.
Measured: 3 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start20 Feb 2024
- Primary completion20 May 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser AcupunctureStudies 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
- Model description
- two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ali Galal El Sayed, Cairo University
- Investigators
- Cairo University, Principal investigator, Faculty of physical therapy cairo universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342791
- Sponsor's protocol ID
- 004349
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and informed consent form
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Menstrual Back Pain
- ClinicalTrials.gov ID
- NCT06342791
- Acronym / sponsor ID
- 004349
- Conditions
- Laser Acupuncture, Low Back Pain, Menstruation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 2 Apr 2024 (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.
effect of laser acupuncture on menstrual back pain
Detailed description
The aim of this study is to determine the effect of laser acupuncture on the points BL23, BL26, BL40 and SP6 in relieving menstrual back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups
| Arm | Type | Receives |
|---|---|---|
| Group A (study group) | Experimental | Device: laser acupuncturereceived Laser on acupuncture point BL23, BL26, BL40, SP6 |
| Group B (Control group) | Placebo comparator | Device: laser acupuncturereceived sham laser acupuncture on BL23, BL26, BL40, SP6 but the laser was not turned on |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All females will have low back pain during menstruation
- Age of the patients will range from 20-30 years.
- Their BMI will be range from 20-30 kg/ m 2
Key exclusion criteria (4 listed)
- - Psychiatric disorders
- Pelvic floor dysfunction
- Lumber disc prolapse or any Previous surgery on spine.
- Tumor in lumbar spine
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 acupuncturelaser use to stimulate acupuncture points | Device | Group A (study group), Group B (Control group) |
Primary outcome
back Pain intensity during menstruation
Time frame: before 3 month from begining of treatment
It will be assess by Visual analogue scale(VAS). VAS used to indicate the level of pain intensity from 1 to 10, before starting treatment (first record) then after treatment (as second record). A visual analogue scale's (VAS) baseline typically falls at one end of the scale and is frequently denoted by the numbers "no pain" or "0," which indicate for the absence of the sensation being assessed. The other end of the line indicates "worst pain imaginable" or a high numerical value, such as 10
pain threshold
Time frame: Before 3 month from begining of the treatment
Using algometer to measure pain threshold. Before beginning the measurement, a pressure algometer's baseline is usually set at zero pressure. This means that the initial pressure applied by the algometer is zero, and then the pressure is gradually increased until the individual being tested starts to feel pain or discomfort. This baseline helps to establish a reference point for measuring pain thresholds or sensitivity to pressure
Ability to perform daily activities
Time frame: Before 3 month from begining of the treatment
Ability to perform daily activities will be assess by using Instrumental activities of daily living (IADL).This scale has been designed to give information about how back pain has affected the ability to manage everyday life. IADLs are scored based on what an individual can do rather than what she is doing. Ask patient to answer every section and mark in each section only the one box which most closely describes the condition at this time. There are 22 questions and rate them on the scale at right. The higher scores mean a better.
3 secondary outcomes
back Pain intensity during menstruation
Time frame: 3 month after treatment
pain threshold
Time frame: 3 month after treatment
Ability to perform daily activities
Time frame: 3 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. Study protocol and informed consent form
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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.
Cairo University principal investigator
Faculty of physical therapy cairo universty
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 acupuncture in people with Laser Acupuncture and Low Back Pain, 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 3 inclusion and 4 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 2 Apr 2024. 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 Mai Ali Galal El sayed (01152457470, Princessmai828@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
back Pain intensity during menstruation (time frame: before 3 month from begining of treatment). The study lists 3 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 2 Apr 2024.