Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women

March 22, 2024 updated by: merve yilmaz menek, Istanbul Medipol University Hospital

Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema, and Quality of Life in Pregnant Women: Randomized Controlled Trial

This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women.

Methods: Sixty pregnant women between 24 and 36 weeks of pregnancy were included in the study. Pregnant women were randomly divided into two groups: The percussion massage treatment (PMT) group and the control group. Pregnant women included in the PMT group received a total of 10 sessions of percussion massage therapy, applied to their bilateral medial gastrocnemius, lateral gastrocnemius, peronus longus and tibialis anterior muscles three times a week. No massage therapy was applied to the lower extremities of the pregnant women in the control group. Pain assessment with Visual analog scale (VAS), ankle, knee, and thigh circumference measurements with tape measure, fatigue level with Fatigue Severity Scale (FSS), and quality of life assessment with Short Form- 36 (SF-36) were conducted.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • İstanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • being pregnant between the ages of 18-40,
  • being in the 24-36 weeks of pregnancy,
  • not being at risk of pregnancy,
  • being pregnant with a single baby,
  • having complaints of pain or edema in the lower extremities,
  • volunteering to participate in the study 3 days a week

Exclusion Criteria:

  • multiple pregnancies,
  • pregnant women with anemia,
  • presence of circulatory problems,
  • cardiovascular disease,
  • chronic orthopedic disease,
  • foot-related orthopedic and vascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PMT Group
Pregnant women included in this group received a total of 12 sessions of percussion massage therapy, applied to their bilateral lower extremities for four weeks.
Other: percussion massage therapy
Pregnant women included in this group received a total of 12 sessions of percussion massage therapy, applied to their bilateral lower extremities for four weeks. Percussion massage was applied to both extremities at separate times for 5 minutes each with the Hypervolt device. (Fig. 2) Four muscles in total were focused on; These muscles are medial gastrocnemius, lateral gastrocnemius, peronus longus, and tibialis anterior. Percussion massage was applied in the longitudinal direction of the muscle, from distal to proximal and back to distal, going from posterior to anterior muscle groups. Percussion massage started on the medial side and ended on the lateral side for each muscle. Equal pressure and duration were applied to each muscle.
No Intervention: Control Group
No massage therapy was applied to the lower extremities of the pregnant women in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Visual Analog Scale (VAS)
Time Frame: 5 minutes
The VAS is a single-item scale with a line length of 10 cm. In this line, 0 means "I have no pain," whereas 10 means "worst pain" at the end. Participants were asked to indicate on a 10-point scale how much discomfort they were experiencing
5 minutes
Evaluation of edema
Time Frame: 10 minutes
Measurement was made with a non-flexible tape measure. Care was taken not to compress the tissues during measurement. The patient should be in a comfortable position on his back. The measurement was made with a tape measure, on the medial and lateral malleolar areas for the foot, on the midline of the patella for the knee, and the widest area for the calf and thigh.
10 minutes
Fatigue Severity Scale (FSS)
Time Frame: 5 minutes
It includes the evaluation of the severity and timing of fatigue and the effects of fatigue on daily activities in individuals. It covers the fatigue severity of individuals in the last month. Each question on the scale is scored between 1 and 7 and contains nine questions in total. The arithmetic average of all scores was taken
5 minutes
Short Form-36 (SF-36)
Time Frame: 15 minutes
The test that consists of 36 items and evaluates 8 subheadings assess the level of quality of life. It includes testing of physical and social function, role limitations due to physical and emotional problems, pain, mental health, energy, and finally general perception of health. The second question of the scale covers the 12-month evaluation and the remaining questions cover the last month. The questions are Likert-type, except for the fourth and fifth questions. The score is calculated by reversing items 1, 6, 7, 8, 9a, 9d, 9e, 9h, 11b, 11d of the scale. The score covers the range from 0 to 100. While 0 describes poor health, 100 describes good health
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Merve Yilmaz Menek, PhD, Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2022

Primary Completion (Actual)

June 4, 2023

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-5416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not to planned to share individual participant data (IPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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