DiastasisNCT06214650
Diastasis Recti Abdominis and a Combined Treatment With Abdominal Exercise and Radiofrequency
A study testing Radiofrequency in people with Diastasis and Diastasis Recti, run by University of Castilla-La Mancha.
Trial summary
Diastasis recti abdominis is a pathology that appears in a high percentage of women during the postpartum period. However, there is little evidence about its treatment. The present protocol aims to evaluate the efficacy of radiofrequency as an alternative for the treatment of abdominal diastasis along with abdominal… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diastasis, Diastasis Recti, Diastasis Recti and Weakness of the Linea Alba
- What is being tested?
- Radiofrequency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with diastasis recti abdominis (DRA)
- Age range18-45 years old
- Women not DRA treated previously
- Women not diagnosed with umbilical hernia
Who cannot join
- DRA width less than 2.5cm
- Women diagnosed with intestinal disease such as irritable bowel syndrome (IBS) or Chron disease.
- Women looking for a new pregnancy or pregnant women.
- Women who can not receive diathermy treatment (e.g tumoral process, open wound in the abdominal area or any diathermy contraindication).
About this study
Official title: Efficacy of a Combined Treatment With Abdominal Exercise and Radiofrequency in Postpartum Women With Diastasis Recti Abdominis
Diastasis recti abdominis is a pathology that appears in a high percentage of women during the postpartum period. However, there is little evidence about its treatment. The present protocol aims to evaluate the efficacy of radiofrequency as an alternative for the treatment of abdominal diastasis along with abdominal exercises compared to the only intervention through abdominal exercise.
An aleatory clinical testing will be conducted where 44 women diagnosed with diastasis recti abdominis in the postpartum period will be recruited. A common exercise protocol will be applied for two groups of participants, and both of them will have to be able to carry out the activities autonomously at home. In addition, control sessions will be held weekly for both groups where one of the groups, the control group (n=22), will receive radiofrequency therapy with the machine in athermic mode, while the other group, the experimental group (n=22), will receive a weekly session under the established diathermy protocol. The sessions will last 30 minutes and will take place for 10 consecutive weeks.
Three variables will be evaluated: the width of the diastasis measured in centimeters, life quality measured using the Short form (36) questionnaire, and the perception of the pain measured with the visual analogue scale. Three evaluations will be done: at the beginning of the study, after ten weeks and three months later.
- Conditions
- Diastasis, Diastasis Recti, Diastasis Recti and Weakness of the Linea Alba, Diastasis Recti Abdominis
- Being tested
- Radiofrequency, Control
- Medical subject headings
- Diastasis Recti And Weakness Of The Linea Alba
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyOther
Experimental group will receive the common exercise program associated with a radiofrequency treatment using INDIBA® (INDIBA Activ 7, Barcelona, INDIBA S.A.) at a frequency of 448 hertz. It will use the capacitive electrode as a method of preparation and vascularization of the superficial tissues and immediately, within the same session, the resistive electrode to stimulate deep tissues. This treatment is based on the protocols established by INDIBA® S.A.
It will consist of one weekly diathermy session of thirty minutes during ten weeks. The use of diathermy will not be interrupted throughout the session.
The common exercise program consist in a ten abdominal exercises (including recti abdominis, transversus and obliques). It will practised at home only just three days at week.
ControlOther
Control group will receive a weekly INDIBA® session in the abdominal area with the same protocol as the experimental group in athermic mode (placebo treatment) and the common exercise program. The session will last thirty minutes and will be carried out by the research physiotherapist during ten weeks.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency group | Experimental | All participants will be receive two interventions:
1. A weekly session for 10 weeks with radiofrequency. It will be use the protocol of INDIBA. Each session will last 30 minutes.
2. Participants will do an homely exercise protocol. This protocol will practise for 3 days at week. Receives: Other: Radiofrequency |
| Control group | Active comparator | All participants will be receive two interventions:
1. A weekly session for 10 weeks with radiofrequency. It will be use INDIBA without intensity such as a placebo. Each session will last 30 minutes.
2. Participants will do an homely exercise protocol. This protocol will practise for 3 days at week. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of the diastasis recti abdominis
The inter-recti diastasis will be measured with a transabdominal ultrasound using a lineal transductor. It will be assessed three measures: 2cm and 5cm above the umbilicus and 2cm below the umbilicus.
Measured: It will be collected two measures to compare the changes: at baseline to the study and ten weeks later.
Secondary outcomes (2)
Participant's quality of life
Quality of life will be assessed using the Short form (36) questionnaire, which consist in thirty six questions about how pathology affects the participant's life.
Measured: At baseline pre intervention and inmediately after the intervention (10 weeks later)
Low back pain
It will analysed the low back pain in the participants using the visual analogic scale (VAS). The participants will choose a level of pain (0-5) in the scale.
Measured: At baseline pre intervention and inmediately after the intervention (10 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiastasisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LOURDES PEÑA ROMERO, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214650
- Sponsor's protocol ID
- Lpena1
- Status last verified
- May 2024
- First submitted
- 27 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combined Treatment With Abdominal Exercise and Radiofrequency in Postpartum Women With Diastasis Recti Abdominis
- ClinicalTrials.gov ID
- NCT06214650
- Acronym / sponsor ID
- Lpena1
- Conditions
- Diastasis, Diastasis Recti, Diastasis Recti and Weakness of the Linea Alba, Diastasis Recti Abdominis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 19 Jan 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.
Diastasis recti abdominis is a pathology that appears in a high percentage of women during the postpartum period. However, there is little evidence about its treatment. The present protocol aims to evaluate the efficacy of radiofrequency as an alternative for the treatment of abdominal diastasis along with abdominal exercises compared to the only intervention through abdominal exercise.
An aleatory clinical testing will be conducted where 44 women diagnosed with diastasis recti abdominis in the postpartum period will be recruited. A common exercise protocol will be applied for two groups of participants, and both of them will have to be able to carry out the activities autonomously at home. In addition, control sessions will be held weekly for both groups where one of the groups, the control group (n=22), will receive radiofrequency therapy with the machine in athermic mode, while the other group, the experimental group (n=22), will receive a weekly session under the established diathermy protocol. The sessions will last 30 minutes and will take place for 10 consecutive weeks.
Three variables will be evaluated: the width of the diastasis measured in centimeters, life quality measured using the Short form (36) questionnaire, and the perception of the pain measured with the visual analogue scale. Three evaluations will be done: at the beginning of the study, after ten weeks and three months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency group | Experimental | Other: RadiofrequencyAll participants will be receive two interventions: 1. A weekly session for 10 weeks with radiofrequency. It will be use the protocol of INDIBA. Each session will last 30 minutes. 2. Participants will do an homely exercise protocol. This protocol will practise for 3 days at week. |
| Control group | Active comparator | Other: ControlAll participants will be receive two interventions: 1. A weekly session for 10 weeks with radiofrequency. It will be use INDIBA without intensity such as a placebo. Each session will last 30 minutes. 2. Participants will do an homely exercise protocol. This protocol will practise for 3 days at week. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women diagnosed with diastasis recti abdominis (DRA)
- Age range18-45 years old
- Women not DRA treated previously
- Women not diagnosed with umbilical hernia
Key exclusion criteria (4 listed)
- DRA width less than 2.5cm
- Women diagnosed with intestinal disease such as irritable bowel syndrome (IBS) or Chron disease.
- Women looking for a new pregnancy or pregnant women.
- Women who can not receive diathermy treatment (e.g tumoral process, open wound in the abdominal area or any diathermy contraindication).
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 |
|---|---|---|
| RadiofrequencyExperimental group will receive the common exercise program associated with a radiofrequency treatment using INDIBA® (INDIBA Activ 7, Barcelona, INDIBA S.A.) at a frequency of 448 hertz. It will use the capacitive electrode as a method of preparation and vascularization of the superficial tissues and immediately, within the same session, the resistive electrode to stimulate deep tissues. This treatment is based on the protocols established by INDIBA® S.A. It will consist of one weekly diathermy session of thirty minutes during ten weeks. The use of diathermy will not be interrupted throughout the session. The common exercise program consist in a ten abdominal exercises (including recti abdominis, transversus and obliques). It will practised at home only just three days at week. | Other | Radiofrequency group |
| ControlControl group will receive a weekly INDIBA® session in the abdominal area with the same protocol as the experimental group in athermic mode (placebo treatment) and the common exercise program. The session will last thirty minutes and will be carried out by the research physiotherapist during ten weeks. | Other | Control group |
Primary outcome
Width of the diastasis recti abdominis
Time frame: It will be collected two measures to compare the changes: at baseline to the study and ten weeks later.
The inter-recti diastasis will be measured with a transabdominal ultrasound using a lineal transductor. It will be assessed three measures: 2cm and 5cm above the umbilicus and 2cm below the umbilicus.
2 secondary outcomes
Participant's quality of life
Time frame: At baseline pre intervention and inmediately after the intervention (10 weeks later)
Low back pain
Time frame: At baseline pre intervention and inmediately after the intervention (10 weeks later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency in people with Diastasis and Diastasis Recti, run by University of Castilla-La Mancha.
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 4 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: opening soon, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Width of the diastasis recti abdominis (time frame: It will be collected two measures to compare the changes: at baseline to the study and ten weeks later.). 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 8 May 2024.