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

Sponsor
Badr University (Other)
Overall Status
Completed
CT.gov ID
NCT06026007
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
3.5
Actual Duration (Months)
16.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: advices
  • Other: Traditional physical therapy
  • Other: Acupressure
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
Actual Study Start Date :
Jan 20, 2022
Actual Primary Completion Date :
Mar 30, 2022
Actual Study Completion Date :
May 8, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in foot and ankle edema during pregnancy [Before starting study and after four weeks of intervention]

      Foot Volumeter was used to assess foot and ankle edema

    Secondary Outcome Measures

    1. level of swelling [Before starting study and after 4 weeks of intervention]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 faculty of physical therapy Cairo university Giza Egypt 11432

    Sponsors and Collaborators

    • Badr University

    Investigators

    • Principal Investigator: noha abd el rhaman, doctoral, BUC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha Ahmed Fouad Abd-Elrahman, lecturer for physical therapy for women health, Badr University
    ClinicalTrials.gov Identifier:
    NCT06026007
    Other Study ID Numbers:
    • P.T.REC/12/003363
    First Posted:
    Sep 6, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Noha Ahmed Fouad Abd-Elrahman, lecturer for physical therapy for women health, Badr University
    Edema Leg
    Additional relevant MeSH terms:
    Edema

    Study Results

    No Results Posted as of Sep 11, 2023