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

NCT06026007 | Completed

• 1 other identifier: P.T.REC/12/003363
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Edema

Keywords

Edema Leg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• level of swelling

  Before starting study and after 4 weeks of intervention

Study Arms (3)

Control group

EXPERIMENTAL

patient in this group received advice only for edema relief

Other: advices

Circulatory exercise group

EXPERIMENTAL

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

Other: advices; Other: Traditional physical therapy

Acupressure group

EXPERIMENTAL

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

Other: advices; Other: Acupressure

Interventions

advices OTHER

each pregnant woman was advices how to elevate her legs and daily positions to elevate edema

Also known as: daily advices

Acupressure group; Circulatory exercise group; Control group

Traditional physical therapy OTHER

each pregnant woman was advised about daily routine in addition to circulatory exercise

Also known as: circulatory exercise

Circulatory exercise group

Acupressure OTHER

each pregnant woman was advised about daily routine in addition to acupressure therapy

Also known as: acupressure therapy

Acupressure group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

faculty of physical therapy Cairo university

Giza, 11432, Egypt

Location

MeSH Terms

Interventions

Counseling; Acupressure

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• noha abd el rhaman, doctoral

  BUC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer for physical therapy for women health

Model Details: 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 Record Dates

• First Submitted: July 30, 2022
• First Posted: September 6, 2023
• Study Start: January 20, 2022
• Primary Completion: March 30, 2022
• Study Completion: May 8, 2022
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will become available after publication
• Access Criteria: data will become available after publication

Locations

EG (1)