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

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06338254
• Other study ID #: E-10840098-772.02-5416
• Status: Completed
• Phase: N/A
• Start date: September 4, 2022
• Est. completion date: June 10, 2023

Study information

• Verified date: March 2024
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 10, 2023
• Est. primary completion date: June 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Edema Leg
• Physiotherapy
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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