search
Back to results

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

Primary Purpose

Gestational Edema

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
advices
Traditional physical therapy
Acupressure
Sponsored by
Badr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Edema focused on measuring Edema Leg

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • faculty of physical therapy Cairo university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control group

Circulatory exercise group

Acupressure group

Arm Description

patient in this group received advice only for edema relief

patient in this group received advice in addition to circulatory exercise for edema relief

patient in this group received advice in addition to acupressure for edema relief

Outcomes

Primary Outcome Measures

change in foot and ankle edema during pregnancy
Foot Volumeter was used to assess foot and ankle edema

Secondary Outcome Measures

level of swelling
Patient reported oedema Questionnaire was used to determine the level of swelling

Full Information

First Posted
July 30, 2022
Last Updated
September 7, 2023
Sponsor
Badr University
search

1. Study Identification

Unique Protocol Identification Number
NCT06026007
Brief Title
Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
Official Title
Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
May 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Edema
Keywords
Edema Leg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
patient in this group received advice only for edema relief
Arm Title
Circulatory exercise group
Arm Type
Experimental
Arm Description
patient in this group received advice in addition to circulatory exercise for edema relief
Arm Title
Acupressure group
Arm Type
Experimental
Arm Description
patient in this group received advice in addition to acupressure for edema relief
Intervention Type
Other
Intervention Name(s)
advices
Other Intervention Name(s)
daily advices
Intervention Description
each pregnant woman was advices how to elevate her legs and daily positions to elevate edema
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Other Intervention Name(s)
circulatory exercise
Intervention Description
each pregnant woman was advised about daily routine in addition to circulatory exercise
Intervention Type
Other
Intervention Name(s)
Acupressure
Other Intervention Name(s)
acupressure therapy
Intervention Description
each pregnant woman was advised about daily routine in addition to acupressure therapy
Primary Outcome Measure Information:
Title
change in foot and ankle edema during pregnancy
Description
Foot Volumeter was used to assess foot and ankle edema
Time Frame
Before starting study and after four weeks of intervention
Secondary Outcome Measure Information:
Title
level of swelling
Description
Patient reported oedema Questionnaire was used to determine the level of swelling
Time Frame
Before starting study and after 4 weeks of intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
noha abd el rhaman, doctoral
Organizational Affiliation
BUC
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy Cairo university
City
Giza
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

We'll reach out to this number within 24 hrs