Effect of Laser Acupuncture on Menstrual Back Pain

March 29, 2024 updated by: Mai Ali Galal El Sayed, Cairo University
effect of laser acupuncture on menstrual back pain

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt, 37617692
        • Recruiting
        • Faculty of physical therapy cairo university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • - Psychiatric disorders
  • Pelvic floor dysfunction
  • Lumber disc prolapse or any Previous surgery on spine.
  • Tumor in lumbar spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A (study group)
received Laser on acupuncture point BL23, BL26, BL40, SP6
Device: laser acupuncture
laser use to stimulate acupuncture points
Placebo Comparator: Group B (Control group)
received sham laser acupuncture on BL23, BL26, BL40, SP6 but the laser was not turned on
Device: laser acupuncture
laser use to stimulate acupuncture points

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
before 3 month from begining of treatment
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
Before 3 month from begining of the treatment
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.
Before 3 month from begining of the treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
back Pain intensity during menstruation
Time Frame: 3 month after 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
3 month after treatment
pain threshold
Time Frame: 3 month after 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
3 month after treatment
Ability to perform daily activities
Time Frame: 3 month after 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 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cairo University, Faculty of physical therapy cairo universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 004349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and informed consent form

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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