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

NCT06338254 | Completed

• 1 other identifier: E-10840098-772.02-5416
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Complications; Edema Leg; Physiotherapy

Keywords

Edema; pain; percussion massage therapy; pregnancy; quality of life

Outcome Measures

Primary Outcomes (4)

• The Visual Analog Scale (VAS)

  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

  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)

  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)

  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

Study Arms (2)

PMT Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No massage therapy was applied to the lower extremities of the pregnant women in this group.

Interventions

percussion massage therapy OTHER

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.

PMT Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Coban A, Sirin A. Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in Turkey. Int J Nurs Pract. 2010 Oct;16(5):454-60. doi: 10.1111/j.1440-172X.2010.01869.x.

  PMID: 20854342 RESULT

Related Links

• Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in Turkey

MeSH Terms

Conditions

Pregnancy Complications; Edema; Pain

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• MERVE YILMAZ MENEK, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 29, 2024
• Study Start: September 4, 2022
• Primary Completion: June 4, 2023
• Study Completion: June 10, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)