Pregnancy ComplicationsNCT06338254
Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women
A study testing percussion massage therapy in people with Pregnancy Complications and Edema Leg, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Edema Leg, Physiotherapy
- What is being tested?
- percussion massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2022to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- multiple pregnancies,
- pregnant women with anemia,
- presence of circulatory problems,
- cardiovascular disease,
- chronic orthopedic disease,
- foot-related orthopedic and vascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pregnancy Complications, Edema Leg, Physiotherapy
- Being tested
- percussion massage therapy
- Keywords
- Edema, pain, percussion massage therapy, pregnancy, quality of life
- Medical subject headings
- Pregnancy Complications, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percussion massage therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: percussion massage therapy |
| Control Group | No intervention | No massage therapy was applied to the lower extremities of the pregnant women in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start4 Sep 2022
- Primary completion4 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yilmaz menek, Istanbul Medipol University Hospital
- Investigators
- MERVE YILMAZ MENEK, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338254
- Sponsor's protocol ID
- E-10840098-772.02-5416
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not to planned to share individual participant data (IPD)
Publications
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.
PubMed 20854342
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06338254
- Acronym / sponsor ID
- E-10840098-772.02-5416
- Conditions
- Pregnancy Complications, Edema Leg, Physiotherapy
- Keywords
- Edema, pain, percussion massage therapy, pregnancy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2022 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMT Group | Experimental | Other: percussion massage therapyPregnant women included in this group received a total of 12 sessions of percussion massage therapy, applied to their bilateral lower extremities for four weeks. |
| Control Group | No intervention | –No massage therapy was applied to the lower extremities of the pregnant women in this group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- multiple pregnancies,
- pregnant women with anemia,
- presence of circulatory problems,
- cardiovascular disease,
- chronic orthopedic disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percussion massage therapyPregnant 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. | Other | PMT Group |
Primary outcome
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Results publication: PubMed 20854342Coban 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.
- Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in TurkeyLink provided by the sponsor.
- Individual participant dataSharing planned: No. It is not to planned to share individual participant data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MERVE YILMAZ MENEK, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percussion massage therapy in people with Pregnancy Complications and Edema Leg, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analog Scale (VAS) (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.