Effect of Laser Acupuncture on Menstrual Back Pain

NCT06342791 | Recruiting

• 1 other identifier: 004349
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

effect of laser acupuncture on menstrual back pain

Conditions

Laser Acupuncture; Low Back Pain; Menstruation

Outcome Measures

Primary 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

  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 Outcomes (3)

• back Pain intensity during menstruation

  3 month after treatment

• pain threshold

  3 month after treatment

• Ability to perform daily activities

  3 month after treatment

Study Arms (2)

Group A (study group)

EXPERIMENTAL

received Laser on acupuncture point BL23, BL26, BL40, SP6

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

Device: laser acupuncture

Interventions

laser acupuncture DEVICE

laser use to stimulate acupuncture points

Group A (study group); Group B (Control group)

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: \- Female who suffers from low back pain during menstruation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy cairo university

Cairo, 37617692, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cairo University

  Faculty of physical therapy cairo universty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mai Ali Galal El sayed

CONTACT

01152457470; Princessmai828@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: laser acupuncture
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two groups

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: April 2, 2024
• Study Start: February 20, 2024
• Primary Completion: May 20, 2024
• Study Completion: June 20, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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).

Locations

EG (1)