Effect of Combined Program of Electro Acupuncture With Exercise on Symphysis Pubis Dysfunction During Pregnancy
Effect of Combined Program of Electro Acupuncture With Exercise on Symphysis Pubis Dysfunction During Pregnancy: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Banī Suwayf, Egypt
- Beni-Suef University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 60 primipara and multipara pregnant women at 25-28 weeks' of gestation diagnosed with symphysis pubis dysfunction were involved. Their ages ranged from 25-40 years and their body mass index (BMI) did not surpass 35 kg/m2.
Exclusion Criteria:
- Exclusion criteria included participants who were diagnosed with placenta previa, unexplained vaginal bleeding, or active preterm labor, as well as patients with a history of recurrent miscarriage, cervical insufficiency, or current multiple gestation.12,13 Additionally, patients with the presence of a cardiac pacemaker, implanted defibrillator, or seizure disorder because of electromagnetic interference and the potential to lower the seizure threshold.14 Cutaneous infection, severe edema, or dermatitis over the intended needling sites were also exclusion criteria, as they increase the likelihood of local complications and systemic spread of infection.15 Coagulopathies, thrombocytopenia, or current anticoagulant therapy represent absolute contraindications for electro acupuncture.16
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: No Intervention
Placebo Group routine pelvic belt as well as advice
|
|
|
Experimental: Intervention group
Intervention group participants
|
physiotherapy plan of care in the form of sessions composed of electroacupuncture technique combined with relevant therapeutic exercise, wore a pelvic belt and received pieces of advice.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symphysis Pubis Width
Time Frame: 4 months
|
It was described by inter-pubic gap space measured in millimetres by means of ultrasonically before and after 6 weeks of intervention procedure.
|
4 months
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- FMBSUREC/02122025A/Awad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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