Effect of Laser Acupuncture on Postnatal Pelvic Girdle Pain

NCT06715111 | Completed

• 1 other identifier: Alaa-001234
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

this study was done to evaluate the effect of laser acupuncture on pelvic girdle pain postnatal females' patients.

Conditions

Laser Acupuncture; Pelvic Pain; Post Natal

Outcome Measures

Primary Outcomes (1)

• Assessment of change of body mass index

  The study used a method to measure body weight and height of participants in both groups (A \& B) to calculate their body mass index, which was calculated by dividing weight in kg by height in m2 for one shot.

  At baseline and after 4 weeks

Secondary Outcomes (3)

• Assessment of change of physical activity restrictions

  At baseline and after 4 weeks

• Assessment of change of postnatal pelvic girdle pain

  At baseline and after 4 weeks

• Assessment of change of Salivary Cortisol values

  At baseline and after 4 weeks

Study Arms (2)

laser acupuncture

EXPERIMENTAL

included twenty-seven participants whom have postnatal pelvic girdle pain received laser acupuncture over specific acupoints, plus conventional pelvic floor exercises; 30minutes, 3 times/week for consecutive 12 sessions for four weeks

Device: Laser acupuncture; Other: conventional pelvic floor exercise

conventional pelvic floor exercises

ACTIVE COMPARATOR

included twenty-seven participants whom have postnatal pelvic girdle pain received conventional pelvic floor exercises; 30minutes, 3 sessions per week consecutive 12 sessions for four weeks

Other: conventional pelvic floor exercise

Interventions

Laser acupuncture DEVICE

A study used a laser acupuncture device to deliver treatment to 27 participants in Group A. The device, was designed for high power, non-thermal treatment. The device had a Class IV- high power, non-thermal laser with a wave length of 808-905 and a 650 nm wavelength. It had an ergonomic handpiece, high efficiency aiming beam, and adjustable emission intensity range. The device also included two laser safety goggles, a touchscreen stylus, and a retractable banner. Participants were instructed to relax and accurately detect acupoints before application. The device was adjusted for safety and both participants and researchers wore laser goggles.

laser acupuncture

conventional pelvic floor exercise OTHER

The study involved participants from groups A and B who underwent conventional pelvic floor exercises for four weeks. The exercises targeted the pubococcygeus, sphincter ani, and urethral musculatures. Participants underwent a warm-up phase with 3-5 minutes of breathing and circulatory exercises, followed by 10 repetitions, 3-5 sets, a 3-5 minute warm-up, 30 minutes of exercises, and a cool-down in five minutes. The exercise program was repeated three times per week for four weeks. Participants were instructed to ensure bladder emptiness, relax, perform contractions and relaxations, squeeze pelvic floor musculatures around the anus and vagina, and maintain contact with the plinth. The cool-down phase involved supervised training for 3-5 minutes of breathing and circulatory exercises.

conventional pelvic floor exercises; laser acupuncture

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: * Fifty-four women suffering from postnatal pelvic girdle pain, clinically diagnosed by a gynecologist. * Their ages were ranged from 20-45 years old. * Their body mass index was ranged from 25-29.9 kg/m2.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fifty-four women suffering from postnatal pelvic girdle pain, clinically diagnosed by a gynecologist.
• Their ages were ranged from 20-45 years old.
• Their body mass index (BMI) was ranged from 25-29.9 kg/m2.
• They shouldn't have any musculoskeletal or neurological disorders.

You may not qualify if:

• Current pregnancy.
• Malignant condition
• History of acute infection
• Neurological problem
• Mental problem to prevent evaluation and cooperation.
• Having uncontrolled metabolic diseases like diabetes and thyroid disease.
• Athletic females.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Out-patient Clinic of Gynecology department of Mansoura International Hospital, Egypt

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)