AssessmentNCT05966779
Physical Therapy in Lipedema Surgery
An observational study of Assessment and Lipedema, run by University of Alcala at 1 site in Spain.
Trial summary
The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Assessment, Lipedema, Vascular Diseases
- What is being tested?
- modified CDT physical therapy protocol, based on Godoy's Method
- How many people
- 293 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 12 Jul 2023
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: females from undergon a surgical proceeding for lipedema in two private hospitals in Madrid and were treated in a private physical therapy center. After surgery they were recommended to receive CDT by their surgeons. All participants received the same physical therapy treatment. The study was approved by the Clinical Research Committee of Hospital Universitario Principe de Asturias (CEIm 36/2023).
Who may be able to join
- female subject who underwent a lipedema surgery
- recommendation of the surgeon to receive physical therapy
Who cannot join
- unilateral surgery
- lack of data in the clinical history
- only 1-2 physical therapy sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery
The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery.
The main question it aims to answer are:
Read more
- if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days
- if the treatment is effective on preventing complications of these participants after surgery
Participants have been treated in the lasts years and authors recover information of the effects of the treatment.
Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received
Read the detailed description
Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness, and mobility impairment. It affects them physically and psychologically. Purpose: This study aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the postoperative period following lipedema surgery.
Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction.
A descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An inferential analysis will be carried out using paired and unpaired T-tests as One-way and repeated measures ANOVA to search for differences between quantitative outcomes. Pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. All missing values will be excluded from the analysis. In all cases, a P<0.05 value and a 95% confidence interval will be determined forstatistical significance. All statistical analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10.
- Conditions
- Assessment, Lipedema, Vascular Diseases, Dermatologic Complication
- Being tested
- modified CDT physical therapy protocol, based on Godoy's Method
- Keywords
- Lipedema, Physical therapy, Liposuction, Complications, Treatment, Assessment
- Medical subject headings
- Lipedema, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified CDT physical therapy protocol, based on Godoy's MethodOther
modified CDT physical therapy protocol
| Study group | Role | What they receive |
|---|---|---|
| modified CDT physical therapy protocol, based on Godoy's Method | A complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received.
A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of
1. Cervical Stimuli 15min
2. MLD based on Godoy
3. Mechanical lymphatic drainage with RA Godoy® device
4. Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage.
5. Skin care - before and after the bandages- and therapeutic education.
6. Put on compression garments
7. Active movement if possible. Receives: Other: modified CDT physical therapy protocol, based on Godoy's Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogue Scale
Pain assessed using the Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain.
Measured: Baseline, short-term (post-treatment), and 90 days follow-up
Secondary outcomes (4)
edema resorption - volume
lower limb edema is measured
Measured: 2018-2022
complications reported - binary outcome
seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema
Measured: 2018-2022
mobility - scale
1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement
Measured: 2018-2022
patient satisfaction
binary outcome
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jul 2023
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AssessmentStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Cerezo-Téllez, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966779
- Sponsor's protocol ID
- OE36/2023
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery
- ClinicalTrials.gov ID
- NCT05966779
- Acronym / sponsor ID
- OE36/2023
- Conditions
- Assessment, Lipedema, Vascular Diseases, Dermatologic Complication
- Keywords
- Lipedema, Physical therapy, Liposuction, Complications, Treatment, Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 1 Aug 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.
The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery.
The main question it aims to answer are:
- if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days
- if the treatment is effective on preventing complications of these participants after surgery
Participants have been treated in the lasts years and authors recover information of the effects of the treatment.
Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received
Detailed description
Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness, and mobility impairment. It affects them physically and psychologically. Purpose: This study aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the postoperative period following lipedema surgery.
Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction.
A descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An inferential analysis will be carried out using paired and unpaired T-tests as One-way and repeated measures ANOVA to search for differences between quantitative outcomes. Pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. All missing values will be excluded from the analysis. In all cases, a P<0.05 value and a 95% confidence interval will be determined forstatistical significance. All statistical analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified CDT physical therapy protocol, based on Godoy's Method | – | Other: modified CDT physical therapy protocol, based on Godoy's MethodA complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received. A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of 1. Cervical Stimuli 15min 2. MLD based on Godoy 3. Mechanical lymphatic drainage with RA Godoy® device 4. Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage. 5. Skin care - before and after the bandages- and therapeutic education. 6. Put on compression garments 7. Active movement if possible. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- females from undergon a surgical proceeding for lipedema in two private hospitals in Madrid and were treated in a private physical therapy center. After surgery they were recommended to receive CDT by their surgeons. All participants received the same physical therapy treatment. The study was approved by the Clinical Research Committee of Hospital Universitario Principe de Asturias (CEIm 36/2023).
Key inclusion criteria (2 listed)
- female subject who underwent a lipedema surgery
- recommendation of the surgeon to receive physical therapy
Key exclusion criteria (3 listed)
- unilateral surgery
- lack of data in the clinical history
- only 1-2 physical therapy sessions
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 |
|---|---|---|
| modified CDT physical therapy protocol, based on Godoy's Methodmodified CDT physical therapy protocol | Other | modified CDT physical therapy protocol, based on Godoy's Method |
Primary outcome
Pain Visual Analogue Scale
Time frame: Baseline, short-term (post-treatment), and 90 days follow-up
Pain assessed using the Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain.
4 secondary outcomes
edema resorption - volume
Time frame: 2018-2022
complications reported - binary outcome
Time frame: 2018-2022
mobility - scale
Time frame: 2018-2022
patient satisfaction
Time frame: 2018-2022
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 22 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment and Lipedema, run by University of Alcala at 1 site in Spain.
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 2 inclusion and 3 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 22 Sep 2026. 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 Spain. 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?
Pain Visual Analogue Scale (time frame: Baseline, short-term (post-treatment), and 90 days follow-up). 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 22 Sep 2026.