Laser AcupunctureNCT06715111
Effect of Laser Acupuncture on Postnatal Pelvic Girdle Pain
A study testing Laser acupuncture and conventional pelvic floor exercise in people with Laser Acupuncture and Pelvic Pain, run by Cairo University at 1 site in Egypt.
Trial summary
this study was done to evaluate the effect of laser acupuncture on pelvic girdle pain postnatal females' patients. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Laser Acupuncture, Pelvic Pain, Post Natal
- What is being tested?
- Laser acupuncture and conventional pelvic floor exercise
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Out-patient Clinic of Gynecology department of Mansoura International Hospital, Egypt
Al Mansurah
About this study
this study was done to evaluate the effect of laser acupuncture on pelvic girdle pain postnatal females' patients.
Read the 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
- Conditions
- Laser Acupuncture, Pelvic Pain, Post Natal
- Being tested
- Laser acupuncture, conventional pelvic floor exercise
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureDevice
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: conventional pelvic floor exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 4 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser AcupunctureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Gomaa Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715111
- Sponsor's protocol ID
- Alaa-001234
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Postnatal Pelvic Girdle Pain
- ClinicalTrials.gov ID
- NCT06715111
- Acronym / sponsor ID
- Alaa-001234
- Conditions
- Laser Acupuncture, Pelvic Pain, Post Natal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study was done to evaluate the effect of laser acupuncture on pelvic girdle pain postnatal females' patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser acupuncture | Experimental | Device: Laser acupuncture, Other: conventional pelvic floor exerciseincluded 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 |
| conventional pelvic floor exercises | Active comparator | Other: conventional pelvic floor exerciseincluded 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Current pregnancy.
- Malignant condition
- History of acute infection
- Neurological problem
- Mental problem to prevent evaluation and cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupunctureA 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. | Device | laser acupuncture |
| conventional pelvic floor exerciseThe 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. | Other | conventional pelvic floor exercises, laser acupuncture |
Primary outcome
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.
3 secondary outcomes
Assessment of change of physical activity restrictions
Time frame: At baseline and after 4 weeks
Assessment of change of postnatal pelvic girdle pain
Time frame: At baseline and after 4 weeks
Assessment of change of Salivary Cortisol values
Time frame: At baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture and conventional pelvic floor exercise in people with Laser Acupuncture and Pelvic Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of body mass index (time frame: At baseline and after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.