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Completed

NCT Number: NCT06715111

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.

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Key information

Conditions

Laser Acupuncture Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Post Natal Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Al Mansurah, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Assessment of change of body mass index

    Time frame: At baseline and after 4 weeks

    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.

Secondary outcomes

  1. Assessment of change of physical activity restrictions

    Time frame: At baseline and after 4 weeks

    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.

  2. Assessment of change of postnatal pelvic girdle pain

    Time frame: At baseline and after 4 weeks

    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.

  3. Assessment of change of Salivary Cortisol values

    Time frame: At baseline and after 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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