Lymphedema of Upper LimbBCRLNCT05660590
Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema
A study testing complex decongestive physiotherapy with low pressure compression bandage and complex decongestive physiotherapy with high pressure compression bandage in people with Lymphedema of Upper Limb and Breast Cancer Lymphedema, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema The main questions it aims to answer are: Is high or low bandage pressure effective in reducing edema and soft tissue thickness? do bandages applied with high or low… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Lymphedema of Upper Limb, Breast Cancer Lymphedema, Edema Arm
- What is being tested?
- complex decongestive physiotherapy with low pressure compression bandage and complex decongestive physiotherapy with high pressure compression bandage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 18 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 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 2 unilateral BCRL involving whole extremity according to ISL
- To be volunteer.
Who cannot join
- Acute deep vein thrombosis
- Acute soft tissue infection
- Peripheral artery disease in upper extremity
- Systemic diseases with peripheral edema (kidney, hearth insufficiency etc.),
- Allergy to materials used for treatment
- Mental diseases effect cooperation
- Sensory loss in the effected limb
- Open wound in the effected limb.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abany Izzet Baysal University
Bolu, Center, 14030
About this study
Official title: The Effect of Complex Decongestive Physiotherapy Applied With Different Compression Pressures on Skin and Subcutaneous Tissue Thickness in Individuals With Breast Cancer-related Lymphedema: a Double-blinded Randomized Comparison Trial
The goal of this randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema
The main questions it aims to answer are:
- Is high or low bandage pressure effective in reducing edema and soft tissue thickness?
- do bandages applied with high or low bandage pressure comprimise sleep, comfort or subjective benefit from treatment?
Participants will recieve complex decongestive physiotherapy. Bandage will apply high or low pressure. Effects of high and low bandage interface pressures will compare
Read the detailed description
The aim of this study was to evaluate the effect of compression bandage applied with different pressures on skin and subcutaneous thickness in individuals with breast cancer-related lymphedema.
individuals with stage 2 unilateral lymphedema participated in the study. Skin and subcutaneous thicknesses, extremity volumes, sleep quality, treatment benefit, comfort during treatment were evaluated respectively by ultrasound from 6 reference points as dorsum of hand, wrist volar, forearm dorsum, forearm volar, arm dorsum, arm volar, volumetric measurement, Pittsburgh Sleep Quality Index, Patient Benefit Index-Lymphedema, and visual analog scale. Complex decongestive physiotherapy was applied to individuals randomly divided into two groups: low (20-30 mmHg) and high bandage pressure (45-55 mmHg). Individuals were evaluated before treatment, at 1st, 10th session, end of treatment, and at 3 months follow-up.
- Being tested
- complex decongestive physiotherapy with low pressure compression bandage, complex decongestive physiotherapy with high pressure compression bandage
- Keywords
- compelex decongestive physiotherapy, bandage interface pressure, compression therapy
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complex decongestive physiotherapy with low pressure compression bandageOther
Also called Low bandage interface pressure
both group received complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with low bandage interface pressure (20-30 mmHg)
complex decongestive physiotherapy with high pressure compression bandageOther
Also called High bandage interface pressure
complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with high bandage interface pressure (45-55 mmHg)
| Study group | Role | What they receive |
|---|---|---|
| Low bandage pressure | Active comparator | Compression bandages applied with low pressure (20-30 mmHg) Receives: Other: complex decongestive physiotherapy with low pressure compression bandage |
| high bandage pressure | Active comparator | Compression bandages applied with low pressure (45-55 mmHg) Receives: Other: complex decongestive physiotherapy with high pressure compression bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up
Evaluation of skin and subcutaneous tissue thickness and US evaluations were made by a radiologist using a 6-15 MHz linear probe with a LOGIQ US system. Skin and subcutaneous thickness were recorded as milimeter.
Measured: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
change from baseline residual volume with 4 weeks treatment and follow up
Limb volume was determined by the overflowing water method. The volumetric vessel was filled with tap water up to the overflow point of the vessel. Subjects were asked to lean forward while standing and slowly dip their arms into the water until the bar at the base of the volumetric cup snapped between the 2nd and 3rd fingers. During immersion, he was asked to avoid movements that could increase the transport of water. The overflowing water was first taken into a container. Then, the overflow water was calculated by transferring it to the measuring cups. The amount of overflowing water was recorded in ml. Measurements were made bilaterally.
Measured: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Secondary outcomes (3)
sleep quality
Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI). The scale that determines sleep quality consists of 18 questions and evaluates sleep quality in the last four weeks. PSQI has 7 components, and each component is evaluated between 0-3 points. The total score ranges from 0-21 (206). A total score higher than 5 indicates poor sleep quality (28). The sub-dimensions of PSQI are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction
Measured: baseline, 4 weeks, 3 months (follow-up)
Comfort
Patient comfort was evaluated with Visual Analogue Scale at the end of the treatment. It was explained to the individual that 0 point of a 10 cm line represents minimum comfort and 10 point represents maximum comfort. The individual was asked to mark the level of comfort he perceived during the treatment. The point marked by the individual was measured with a ruler and recorded in cm.
Measured: baseline, 4 weeks, 3 months (follow-up)
Subjective benefit from treatment
The benefit from the treatment was evaluated with the Patient Benefit Index-Lymphedema. It consists of two five-point Likert-type questionnaires containing the same 23 questions, the Patient Needs Questionnaire, and the Patient Benefit Questionnaire. Scores of Index are between 0-4. "0" means no benefit from treatment. "4" means maximum benefit from treatment.
score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jun 2019
- Primary completion22 Apr 2022
- Study completion18 May 2022
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 Lymphedema of Upper LimbStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Randomised comparison trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Duygu, Abant Izzet Baysal University
- Investigators
- elif duygu yıldız, Dr, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660590
- Sponsor's protocol ID
- BAIBU-FTR-ED-001
- Acronym
- BCRL
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duygu-Yildiz E, Bakar Y, Hizal M. The effect of complex decongestive physiotherapy applied with different compression pressures on skin and subcutaneous tissue thickness in individuals with breast cancer-related lymphedema: a double-blinded randomized comparison trial. Support Care Cancer. 2023 Jun 7;31(7):383. doi: 10.1007/s00520-023-07843-y.
PubMed 37285046
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Complex Decongestive Physiotherapy Applied With Different Compression Pressures on Skin and Subcutaneous Tissue Thickness in Individuals With Breast Cancer-related Lymphedema: a Double-blinded Randomized Comparison Trial
- ClinicalTrials.gov ID
- NCT05660590
- Acronym / sponsor ID
- BCRL / BAIBU-FTR-ED-001
- Keywords
- compelex decongestive physiotherapy, bandage interface pressure, compression therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 21 Dec 2022 (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 randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema
The main questions it aims to answer are:
- Is high or low bandage pressure effective in reducing edema and soft tissue thickness?
- do bandages applied with high or low bandage pressure comprimise sleep, comfort or subjective benefit from treatment?
Participants will recieve complex decongestive physiotherapy. Bandage will apply high or low pressure. Effects of high and low bandage interface pressures will compare
Detailed description
The aim of this study was to evaluate the effect of compression bandage applied with different pressures on skin and subcutaneous thickness in individuals with breast cancer-related lymphedema.
individuals with stage 2 unilateral lymphedema participated in the study. Skin and subcutaneous thicknesses, extremity volumes, sleep quality, treatment benefit, comfort during treatment were evaluated respectively by ultrasound from 6 reference points as dorsum of hand, wrist volar, forearm dorsum, forearm volar, arm dorsum, arm volar, volumetric measurement, Pittsburgh Sleep Quality Index, Patient Benefit Index-Lymphedema, and visual analog scale. Complex decongestive physiotherapy was applied to individuals randomly divided into two groups: low (20-30 mmHg) and high bandage pressure (45-55 mmHg). Individuals were evaluated before treatment, at 1st, 10th session, end of treatment, and at 3 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised comparison trial
| Arm | Type | Receives |
|---|---|---|
| Low bandage pressure | Active comparator | Other: complex decongestive physiotherapy with low pressure compression bandageCompression bandages applied with low pressure (20-30 mmHg) |
| high bandage pressure | Active comparator | Other: complex decongestive physiotherapy with high pressure compression bandageCompression bandages applied with low pressure (45-55 mmHg) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage 2 unilateral BCRL involving whole extremity according to ISL
- To be volunteer.
Key exclusion criteria (8 listed)
- Acute deep vein thrombosis
- Acute soft tissue infection
- Peripheral artery disease in upper extremity
- Systemic diseases with peripheral edema (kidney, hearth insufficiency etc.),
- Allergy to materials used for treatment
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 |
|---|---|---|
| complex decongestive physiotherapy with low pressure compression bandageAlso: Low bandage interface pressureboth group received complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with low bandage interface pressure (20-30 mmHg) | Other | Low bandage pressure |
| complex decongestive physiotherapy with high pressure compression bandageAlso: High bandage interface pressurecomplex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with high bandage interface pressure (45-55 mmHg) | Other | high bandage pressure |
Primary outcome
change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up
Time frame: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Evaluation of skin and subcutaneous tissue thickness and US evaluations were made by a radiologist using a 6-15 MHz linear probe with a LOGIQ US system. Skin and subcutaneous thickness were recorded as milimeter.
change from baseline residual volume with 4 weeks treatment and follow up
Time frame: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Limb volume was determined by the overflowing water method. The volumetric vessel was filled with tap water up to the overflow point of the vessel. Subjects were asked to lean forward while standing and slowly dip their arms into the water until the bar at the base of the volumetric cup snapped between the 2nd and 3rd fingers. During immersion, he was asked to avoid movements that could increase the transport of water. The overflowing water was first taken into a container. Then, the overflow water was calculated by transferring it to the measuring cups. The amount of overflowing water was recorded in ml. Measurements were made bilaterally.
3 secondary outcomes
sleep quality
Time frame: baseline, 4 weeks, 3 months (follow-up)
Comfort
Time frame: baseline, 4 weeks, 3 months (follow-up)
Subjective benefit from treatment
Time frame: 4 weeks
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 Dec 2022.
- Derived from this study: PubMed 37285046Duygu-Yildiz E, Bakar Y, Hizal M. The effect of complex decongestive physiotherapy applied with different compression pressures on skin and subcutaneous tissue thickness in individuals with breast cancer-related lymphedema: a double-blinded randomized comparison trial. Support Care Cancer. 2023 Jun 7;31(7):383. doi: 10.1007/s00520-023-07843-y.
- Individual participant dataSharing planned: No
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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.
elif duygu yıldız, Dr principal investigator
Abant Izzet Baysal 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 complex decongestive physiotherapy with low pressure compression bandage and complex decongestive physiotherapy with high pressure compression bandage in people with Lymphedema of Upper Limb and Breast Cancer Lymphedema, run by Abant Izzet Baysal University 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 2 inclusion and 8 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 Dec 2022. 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?
change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up (time frame: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)). The study lists 2 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 NCT05660590, 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 Dec 2022.