Limb swelling under control - effective therapies and modern diagnostics
| ISRCTN | ISRCTN14958964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14958964 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | No. 1/01/2025 |
| Sponsor | Provita Medical Centre |
| Funder | Provita Medical Center |
- Submission date
- 31/05/2025
- Registration date
- 03/06/2025
- Last edited
- 03/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Lymphedema is a chronic condition causing limb swelling due to fluid buildup. This study evaluates modern physiotherapeutic techniques to improve limb function and reduce symptoms. It aims to test diagnostic tools and therapies like compression, exercises, and kinesiotaping to enhance circulation and prevent relapses.
Who can participate?
Adults aged 18–80 years with a diagnosis of secondary lymphedema in one limb (stages I–III) are eligible. Participants must be in stable condition and able to follow instructions. Healthy volunteers without swelling history may be included in control groups.
What does the study involve?
Participants are randomly assigned to different treatment arms, such as resistance training, compression, kinesiotaping, or placebo. Interventions last 4 to 12 weeks, with 2–5 sessions weekly. Assessments are conducted before, immediately after, and up to 3 months after treatment. The study uses tools like ultrasound, myotonometry, and flowmetry to measure tissue condition and circulation.
What are the possible benefits and risks of participating?
Participants may benefit from improved limb function, reduced swelling, and better quality of life. Risks are minimal and may include mild discomfort during exercise or measurement. All procedures follow safety standards.
Where is the study run from?
1. Medical Centre Provita, Żory, Poland
2. Health Workshop, Wrocław, Poland
3. Feldbergklinik Dr. Asdonk GmbH, St. Blasien, Germany
When is the study starting and how long is it expected to run for?
March 2025 to November 2026
Who is funding the study?
Provita Medical Center (Poland)
Who is the main contact?
Dr Robert Trybulski, rtrybulski.provita@gmial.com
Contact information
Public, Scientific, Principal investigator
Health Workshopul. Przyjazni 58/4u
Wroclaw
53-030
Poland
 ORCID ID |
0000-0003-2357-5803 |
|---|---|
| Phone | +48 (0)665799922 |
| m.h.smoter@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multiphase mixed-method randomized controlled trial with parallel and crossover designs |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 47425_PIS_Polish.pdf |
| Scientific title | Integrated approach to diagnostics and mechanical-hemodynamic therapy of changes in lymphedema – a physiotherapeutic perspective |
| Study acronym | LIMF-HEMO-MECH |
| Study objectives | 1. The Kuhnke method provides reliable and valid limb volume measurements in patients with lymphedema compared to gold-standard techniques such as water volumetry and bioimpedance. 2. The severity of lymphedema influences the hemodynamic response of the microcirculation, as measured by post-occlusive reactive hyperemia (PORH), with reduced perfusion in more advanced stages. 3. The application of kinesiotaping in patients with upper limb lymphedema significantly enhances PORH parameters, indicating improved microvascular function. 4. Intermittent pneumatic compression (IPC) combined with resistance exercises improves muscle stiffness, tension, strength, and microcirculatory response in patients with chronic lymphedema more effectively than exercises alone. 5. A comprehensive educational program and self-management strategies reduce recurrence rates of lymphedema and improve quality of life over a 12-month observation period compared to standard care. |
| Ethics approval(s) |
Approved 12/03/2025, Ethics Committee at the Polish Physiotherapy Association (ul. Zygmunta Modzelewskiego 37, Warsaw, 02-679, Poland; +48 (0)502591428; biuro@fizjoterapeuci.org), ref: no 1/03/2025 |
| Health condition(s) or problem(s) studied | Lymphedema |
| Intervention | This is a randomized controlled trial. Participants are randomly assigned (1:1) to intervention or control groups using a sequence generated via randomizer.org. The study includes several interventional arms: (A) Strength training for cervical pain (B) Strength training for lumbar pain (C) Plyometric training for football players (D) Occlusion training (BFR) with varying arterial occlusion pressures (60%, 80%, 100%) (E–F) BFR combined with magnetotherapy or sham therapy in patients with type 2 diabetes Control groups receive either sham interventions (e.g., placebo cuff pressure or no plyometric training) or standard physiotherapy. Interventions last 4–12 weeks, depending on the group, with session frequency ranging from 2 to 5 times per week. Outcomes are assessed at baseline, immediately post-intervention, and at 1 week, 1 month, and 3 months post-intervention. The study evaluates biomechanical parameters (muscle tone, stiffness, elasticity), perfusion, pain thresholds, and strength outcomes using validated tools (e.g., Myoton, LDF, ForceDecks, algometer). |
| Intervention type | Mixed |
| Primary outcome measure(s) |
1. Muscle elasticity measured using shear wave elastography (Sonoscape P20, linear probe 5–20 MHz) at baseline, post-intervention, and at 1 week, 1 month, and 3 months |
| Key secondary outcome measure(s) |
1. Muscle thickness measured using ultrasound (Sonoscape P20) at baseline and post-intervention |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 150 |
| Key inclusion criteria | 1. Age 18–80 years 2. Unilateral lymphedema of the upper or lower limb (stage I, II or III according to the clinical classification) 3. Diagnosis of secondary lymphedema (e.g. after oncological, surgical or post-traumatic treatment) 4. Stable clinical condition, without signs of acute inflammation at the site of the swelling 5. No contraindications to physiotherapy, compression therapy, pneumocompression or exercise testing 6. Ability to move independently and follow simple instructions of a physiotherapist 7. Consent to participate in the study expressed in writing after reading the informed consent form In the case of control groups: no active lymphedema and no history of treatment related to the swelling |
| Key exclusion criteria | 1. Diagnosed cardiovascular diseases, such as: heart failure, unstable hypertension (blood pressure >140/90 mmHg), thromboembolic disease 2. Active bacterial, viral or fungal infection in the limb affected by edema 3. Cancer during active treatment (chemotherapy, radiotherapy) or relapse of oncological disease 4. Edema of a non-lymphatic nature (e.g. varicose, renal, cardiogenic, lipid) 5. Open wounds, skin damage or inflammation in the areas of planned measurements or therapy application 6. Pregnancy or postpartum period 7. Neurological disorders affecting motor control (e.g. stroke, multiple sclerosis) 8. Psychiatric disorders that prevent informed consent and cooperation in the study 9. Use of painkillers or anti-inflammatory drugs less than 24 hours before measurement 10. Participation in another clinical trial in the last 30 days 11. Refusal to participate in the study or withdrawal of consent at any time |
| Date of first enrolment | 15/07/2025 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Germany
- Poland
Study participating centres
Żory
44-240
Poland
Wrocłalaw
53-030
Poland
St. Blasien
D-79837
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Other |
| IPD sharing plan | All data collected during the study will be securely stored in compliance with GDPR regulations and institutional data protection policies. Participant-identifying information will be anonymized and data will be encrypted and stored on password-protected devices and institutional servers. Access to raw or processed data will be restricted to authorized members of the research team. Data may be made available upon reasonable request for scientific or audit purposes, provided that it does not compromise participant confidentiality. The principal investigator responsible for data storage and sharing is Dr Małgorzata Smoter (m.h.smoter@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 03/06/2025 | No | Yes | ||
| Participant information sheet | 03/06/2025 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 47425_PIS_Polish.pdf
- Participant information sheet
- 47425_PIS_English.pdf
- Participant information sheet
Editorial Notes
02/06/2025: Study's existence confirmed by the Ethics Committee at the Polish Physiotherapy Association.
