Effect of Laser Acupuncture on Menstrual Back Pain

effect of laser acupuncture on menstrual back pain

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Menstruation; Laser Acupuncture
• Intervention / Treatment: Device: laser acupuncture

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: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai Ali Galal El sayed; Phone Number: 01152457470; Email: Princessmai828@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 37617692
    • Recruiting
    • Faculty of Physical Therapy Cairo University
    • Contact: Mai Ali Galal El sayed; Phone Number: 01152457470; Email: Princessmai828@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	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	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.	Before 3 month from begining of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	3 month after treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Cairo University, Faculty of physical therapy cairo universty

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): May 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID 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