Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy

Incidence of ankle edema is high during pregnancy, If left untreated, it may lead to difficulty walking; stiffness; stretched skin which can become itchy and uncomfortable. Acupressure promotes the condition of the circulatory and lymphatic system leading to the elimination of edema. The aim of this study is to investigate the efficacy of acupressure versus traditional physical therapy treatment on ankle edema during pregnancy.

Study Overview

• Status: Completed
• Conditions: Gestational Edema
• Intervention / Treatment: Other: advices; Other: Traditional physical therapy; Other: Acupressure

Detailed Description

Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into three equal groups, Group A will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and Group B will receive the same traditional treatment as group A in addition to circulatory exercises, 3times per week for 4 weeks; while Group C will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11432
    • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• pregnant women in their third trimester,
• age ranged from 25-35 years and
• BMI was ≥30Kg/m2.

Exclusion Criteria:

• Pregnant women with skin diseases
• irremovable bracelet,
• decreased functional active range of motion in the affected lower extremity
• any mental or physical disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; patient in this group received advice only for edema relief	Other: advices; each pregnant woman was advices how to elevate her legs and daily positions to elevate edema; Other Names: daily advices
Experimental: Circulatory exercise group; patient in this group received advice in addition to circulatory exercise for edema relief	Other: advices; each pregnant woman was advices how to elevate her legs and daily positions to elevate edema; Other Names: daily advices; Other: Traditional physical therapy; each pregnant woman was advised about daily routine in addition to circulatory exercise; Other Names: circulatory exercise
Experimental: Acupressure group; patient in this group received advice in addition to acupressure for edema relief	Other: advices; each pregnant woman was advices how to elevate her legs and daily positions to elevate edema; Other Names: daily advices; Other: Acupressure; each pregnant woman was advised about daily routine in addition to acupressure therapy; Other Names: acupressure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in foot and ankle edema during pregnancy	Foot Volumeter was used to assess foot and ankle edema	Before starting study and after four weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of swelling	Patient reported oedema Questionnaire was used to determine the level of swelling	Before starting study and after 4 weeks of intervention

Collaborators and Investigators

• Sponsor: Badr University
• Investigators: Principal Investigator: noha abd el rhaman, doctoral, BUC

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): May 8, 2022

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: September 3, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Edema Leg
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: P.T.REC/12/003363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: only data of the study will be shared
• IPD Sharing Time Frame: data will become available after publication
• IPD Sharing Access Criteria: data will become available after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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