Effect of Laser Acupuncture on Postnatal Pelvic Girdle Pain

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

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Laser Acupuncture; Post Natal
• Intervention / Treatment: Device: Laser acupuncture; Other: conventional pelvic floor exercise

Detailed Description

Postnatal pelvic girdle pain might be addressed as a gynecologic challenge in the 21 century in women of all ages and it frequently occur simultaneously. Various forms of postnatal pelvic girdle pain were aggravated by moderate daily activities. Laser acupuncture is a therapeutic modality focuses on selected acupoints in a safe maneuver

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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: laser acupuncture; 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; 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.; Other: conventional pelvic floor exercise; 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.
Active Comparator: conventional pelvic floor exercises; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of physical activity restrictions	The Postnatal Pelvic Girdle Pain Questionnaire was used to assess physical activity restrictions in participants with postnatal pelvic girdle pain before and after treatment. The Postnatal Pelvic Girdle Pain Questionnaire, consisting of 25 items, is a reliable and valid clinical evaluating tool for women with pelvic floor disorders, making it a globally used tool.	At baseline and after 4 weeks
Assessment of change of postnatal pelvic girdle pain	The Posterior Pelvic Pain Provocation Test was used to assess postnatal pelvic girdle pain in both A&B groups before and after treatment. The test involved a clinician stabilizing the pelvis and applying slight pressure to the femur. A positive Posterior Pelvic Pain Provocation Test was considered if the participant experienced similar pain.	At baseline and after 4 weeks
Assessment of change of Salivary Cortisol values	Salivary cortisol values were used as an objective biomarker to assess physiologic and psychologic stress associated with postnatal pelvic girdle pain in both groups (A&B) before and after treatment. Saliva was collected before teeth brushing or breaking nocturnal fast, and samples were kept cold and stored at -20°C until laboratory analysis.	At baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Girdle Pain; Pelvic Pain
• Other Study ID Numbers: Alaa-001234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No