Gestational EdemaNCT06026007
Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
A study testing advices, Traditional physical therapy and Acupressure in people with Gestational Edema, run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Gestational Edema
- What is being tested?
- advices, Traditional physical therapy and Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2022to 8 May 2022
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women in their third trimester,
- age ranged from 25-35 years and
- BMI was ≥30Kg/m2.
Who cannot join
- Pregnant women with skin diseases
- irremovable bracelet,
- decreased functional active range of motion in the affected lower extremity
- any mental or physical disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Gestational Edema
- Being tested
- advices, Traditional physical therapy, Acupressure
- Keywords
- Edema Leg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advicesOther
Also called daily advices
each pregnant woman was advices how to elevate her legs and daily positions to elevate edema
Traditional physical therapyOther
Also called circulatory exercise
each pregnant woman was advised about daily routine in addition to circulatory exercise
AcupressureOther
Also called acupressure therapy
each pregnant woman was advised about daily routine in addition to acupressure therapy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | patient in this group received advice only for edema relief Receives: Other: advices |
| Circulatory exercise group | Experimental | patient in this group received advice in addition to circulatory exercise for edema relief Receives: Other: advices; Other: Traditional physical therapy |
| Acupressure group | Experimental | patient in this group received advice in addition to acupressure for edema relief Receives: Other: advices; Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in foot and ankle edema during pregnancy
Foot Volumeter was used to assess foot and ankle edema
Measured: Before starting study and after four weeks of intervention
Secondary outcomes (1)
level of swelling
Patient reported oedema Questionnaire was used to determine the level of swelling
Measured: Before starting study and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start20 Jan 2022
- Primary completion30 Mar 2022
- Study completion8 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational EdemaStudies 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ahmed Fouad Abd-Elrahman, Badr University
- Investigators
- noha abd el rhaman, doctoral, Principal investigator, BUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026007
- Sponsor's protocol ID
- P.T.REC/12/003363
- Status last verified
- Sep 2023
- First submitted
- 30 Jul 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only data of the study will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
- ClinicalTrials.gov ID
- NCT06026007
- Acronym / sponsor ID
- P.T.REC/12/003363
- Conditions
- Gestational Edema
- Keywords
- Edema Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 8 May 2022 (actual)
- First posted
- 6 Sep 2023 (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.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: advicespatient in this group received advice only for edema relief |
| Circulatory exercise group | Experimental | Other: advices, Other: Traditional physical therapypatient in this group received advice in addition to circulatory exercise for edema relief |
| Acupressure group | Experimental | Other: advices, Other: Acupressurepatient in this group received advice in addition to acupressure for edema relief |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant women in their third trimester,
- age ranged from 25-35 years and
- BMI was ≥30Kg/m2.
Key exclusion criteria (4 listed)
- Pregnant women with skin diseases
- irremovable bracelet,
- decreased functional active range of motion in the affected lower extremity
- any mental or physical disorders.
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 |
|---|---|---|
| advicesAlso: daily adviceseach pregnant woman was advices how to elevate her legs and daily positions to elevate edema | Other | Acupressure group, Circulatory exercise group, Control group |
| Traditional physical therapyAlso: circulatory exerciseeach pregnant woman was advised about daily routine in addition to circulatory exercise | Other | Circulatory exercise group |
| AcupressureAlso: acupressure therapyeach pregnant woman was advised about daily routine in addition to acupressure therapy | Other | Acupressure group |
Primary outcome
change in foot and ankle edema during pregnancy
Time frame: Before starting study and after four weeks of intervention
Foot Volumeter was used to assess foot and ankle edema
1 secondary outcome
level of swelling
Time frame: Before starting study and after 4 weeks of intervention
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 11 Sep 2023.
- Individual participant dataSharing planned: Yes. only data of the study will be shared
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.
noha abd el rhaman, doctoral principal investigator
BUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing advices, Traditional physical therapy and Acupressure in people with Gestational Edema, run by Badr University at 1 site in Egypt.
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 3 inclusion and 4 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 11 Sep 2023. 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 Egypt. 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?
change in foot and ankle edema during pregnancy (time frame: Before starting study and after four weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2023.