The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.
Primary Purpose
Lymphedema, Lymphedema of Upper Arm, Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Complex Decongestive Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of lymphedema disease
- Ages between 18-80 years old,
- 2 cm difference between the affected and unaffected arms in women with breast cancer related lymphedema,
- At least 12 months after breast cancer treatments end and
- Who are agreed to participate in the study.
Exclusion Criteria:
- Women with active infection,
- deep vein thrombosis/thrombophlebitis,
- cardiac edema,
- peripheral artery disease,
- kidney, lung disease,
- primary lymphedema,
- peripheral upper limb nerve injury,
- any surgery other than breast cancer surgeries,
- existing shoulder, elbow, wrist, hand pathologies,
- cooperation problems,
- neurological disease,
- mental illness, diabetes mellitus,
- smoking and patients with open wounds on the upper limb.
Sites / Locations
- Hacettepe UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Affected arm in lymphedema patients
Unaffected arm in lymphedema patients
Arm Description
Complex decongestive physiotherapy treatment will be applied to the arm (affected arm) that develops lymphedema after unilateral breast cancer treatment.
After unilateral breast cancer treatments, the non-lymphedema side in the upper extremities, is the unaffected arm. No treatments will be applied to the unaffected side.
Outcomes
Primary Outcome Measures
Touching sensation
Assessment of touching sensation at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with Semmes-Weinstein Monofilaments in women with breast cancer related lymphedema.
Two-point discrimination
Assessment of two-point discrimination at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an esthesiometer in women with breast cancer related lymphedema.
Pressure pain threshold
Assessment of pressure pain threshold at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an algometer in women with breast cancer related lymphedema.
Secondary Outcome Measures
Vibration sensation
Vibration Sensation Measurement: The vibration sensation will be measured from the lateral epicondyle in the upper extremity by diapasons. Diapason is a small U-shaped tool made of steel that vibrates at a certain height when vibrated. 128 and 256 Hertz diapasons will be vibrated and placed in the patient's lateral epicondyle. The time that the patient feels vibration will be calculated with a chronometer.
Ultrasonographic Imaging
The lymphedema diagnoses of the patients will be confirmed by ultrasonographic imaging method routinely performed in the clinic. Imaging will be performed using a 5-12 MHz linear probe (Logiq P5, GE, Wisconsin, USA) on the upper extremity. Dermis and subcutaneous soft tissue thicknesses; It will be measured using plenty of gel, using images without applying any pressure - with the help of the device's automatic calculation feature after marking.
Environmental measurement
The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.
Hot / Cold Sensory Test
The sense of warm / cold will be evaluated with test tubes containing hot and cold liquid. The cold tube will be filled with water at 10 ° C and the hot tube at 40 ° C. When the patient's eyes are closed, these tubes will be touched to the skin surface 10 cm distal to the volar face elbow joint in a random order, and the patient will be asked to express that the water in the tube is hot or cold.
Lymphedema Life Impact Scale
Lymphedema Life Impact Scale: Weiss et al. The validity and reliability of the questionnaire developed by Orhan et al. made by. Lymphedema life impact scale consists of 18 questions and has physical, psychological and functional subtitles. '0'; no influence, '4'; It is scored between the minimum '0' and the maximum '72' score with a 5-stage Likert-type scale in the form of severe influence. As the score increases, the state of influence worsens.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04296929
Brief Title
The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.
Official Title
The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to determine the effect of complex decongestive physiotherapy in women with unilateral breast cancer-related lymphedema on sensory parameters.
Detailed Description
Although there are a limited number of studies in the literature on disorders of sensory functions seen after breast cancer treatments, sensory disorders that may be seen in lymphedema associated with breast cancer were evaluated in only 2 studies published in 1979 and 2006. Although these studies are not sufficient in terms of study design, they only include Semmes-Weinstein monofilaments and two-point discrimination tests and hand evaluations. Ganel et al. Reported that approximately 50% of the patients they included in the study found that varying degrees of lymphedema developed in the upper extremity, and the median nerve compression in the brachial plexus and carpal tunnel was significantly higher in these patients. They did not find a direct correlation with radiotherapy in patients with nerve compression. They therefore stated that nerve compression may be associated with lymphedema or fibroblast infiltration. According to this study, lymphedema may also be a risk factor in post mastectomy problems such as brachial plexus and carpal tunnel syndrome. Greve et al. reported that lymphedema may cause a decrease in sensory functions in patients who were evaluated with monofilaments in their studies on the effect of lymphedema on sensory functions after mastectomy (Ganel 1979, Greeve 2006).
Complex Decongestive Physiotherapy was developed by Földi in the 1980s in Germany to reduce limb volume, preserve skin health, lymph transport stimulation and reabsorption of residual interstitial proteins. Complex Decongestive Physiotherapy is a treatment method consisting of four main elements and two phases. The four main elements of the first phase of complex decongestive physiotherapy; includes manual lymphatic drainage, skin care, compression therapy and remedial exercises. After the edema is reduced, phase II is passed. This phase includes self-drainage, skin care, personalized compression socks and remedial exercises. In lymphedema, protein-rich fluid accumulates in the subcutaneous tissue for a long time, disrupting natural skin elasticity over time. With Complex Decongestive Physiotherapy, edema reduction up to 65% can be achieved, functional loss, fibrotic changes, and cosmetic problems, which are the secondary problems caused by lymphedema, can be observed.
Increased interstitial fluid in lymphedema associated with breast cancer can cause local sensory loss due to compression of peripheral nerves. Dermal thickness increase due to lymphedema and biomechanical changes in viscoelasticity can cause various changes on sensory functions. Therefore, quantitative evaluation of the sensory system can be an effective method to determine the injury risk factor of the lymphedema region in the event of an existing sensory dysfunction. However, although the effects of Complex Decongestive Physiotherapy on edema reduction, skin thickness and elasticity are mentioned, its effect on sensory functions is unknown.
Complex Decongestive Physiotherapy will be applied to patients for a total of 3 weeks, 5 days a week within the scope of this study.
The assessments will be performed before treatment and at the end of three weeks treatment period.
A detailed story will be taken from the patients first. The lymphedema diagnoses of the patients will be confirmed by ultrasonographic imaging method. Imaging will be performed using a 5-12 MHz linear probe (Logiq P5, GE, Wisconsin, USA) on the upper extremity. Dermis and subcutaneous soft tissue thicknesses; It will be measured using plenty of gel, using images without applying any pressure - with the help of the device's automatic calculation feature after marking.
The severity of lymphedema between the two extremities will be assessed by environmental measurement.
Semmes-Weinstein Monofilament Test: It will be applied 10 cm distal to the elbow joint of the volar surface in the forearm. The measurement will start with the lightest monofilament and proceed to the monofilament that the patient feels. Each monofilament will be applied to a spot three times in a row.
Two Point Discrimination Test: This test is a non-invasive test commonly used in sensory evaluation. It is done by randomly touching one or two points. If 7 of the 10 answers given by the patient are correct, the answer is considered correct. If the answer is not correct, the difference between the two ends of the esthesiometer is increased by 1, 2 or 5 mm depending on the expected state of sensory loss. The test continues until you reach the correct answer. If the correct answer cannot be obtained even at 15 mm, the test is terminated.
The pressure pain threshold will be evaluated with 'J tech Algometer Commander' by giving pressure from both the upper extremity to 10 cm distal from the volar surface of the elbow joint until the patient feels minimal pain. Pressure will be applied vertically with the 1 cm2 head of the device and patients will be asked to say 'yes' whenever they feel uncomfortable with the pressure applied. The measurement will be repeated 3 times, and the pressure pain threshold will be calculated by taking the arithmetic average of these three trials.
Hot / Cold Sensory Test: The sense of warm / cold will be evaluated with test tubes containing hot and cold liquid. The cold tube will be filled with water at 10 °C and the hot tube at 40 °C. When the patient's eyes are closed, these tubes will be touched to the skin surface 10 cm distal to the volar face elbow joint in a random order, and the patient will be asked to express that the water in the tube is hot or cold.
Vibration Sensation Measurement: The vibration sensation will be measured from the lateral epicondyle in the upper extremity by diapason. Diapason is a small U-shaped tool made of steel that vibrates at a certain height when vibrated.
Lymphedema Life Impact Scale: Weiss et al. The validity and reliability of the questionnaire developed by Orhan et al. made by. Lymphedema life impact scale consists of 18 questions and has physical, psychological and functional subtitles. '0'; no influence, '4'; It is scored between the minimum '0' and the maximum '72' score with a 5-stage Likert-type scale in the form of severe influence. As the score increases, the state of influence worsens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Lymphedema of Upper Arm, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Affected arm in lymphedema patients
Arm Type
Experimental
Arm Description
Complex decongestive physiotherapy treatment will be applied to the arm (affected arm) that develops lymphedema after unilateral breast cancer treatment.
Arm Title
Unaffected arm in lymphedema patients
Arm Type
No Intervention
Arm Description
After unilateral breast cancer treatments, the non-lymphedema side in the upper extremities, is the unaffected arm. No treatments will be applied to the unaffected side.
Intervention Type
Other
Intervention Name(s)
Complex Decongestive Physiotherapy
Intervention Description
Complete decongestive therapy (CDT), also called complex decongestive therapy, is an intensive program that combines many of the different treatment approaches, including bandaging, compression garments, manual lymphatic drainage, exercise, and self care.
Primary Outcome Measure Information:
Title
Touching sensation
Description
Assessment of touching sensation at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with Semmes-Weinstein Monofilaments in women with breast cancer related lymphedema.
Time Frame
Change from Baseline touching sensation at 3 weeks
Title
Two-point discrimination
Description
Assessment of two-point discrimination at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an esthesiometer in women with breast cancer related lymphedema.
Time Frame
Change from baseline two-point discrimination at 3 weeks
Title
Pressure pain threshold
Description
Assessment of pressure pain threshold at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an algometer in women with breast cancer related lymphedema.
Time Frame
Change from baseline pressure pain threshold at 3 weeks
Secondary Outcome Measure Information:
Title
Vibration sensation
Description
Vibration Sensation Measurement: The vibration sensation will be measured from the lateral epicondyle in the upper extremity by diapasons. Diapason is a small U-shaped tool made of steel that vibrates at a certain height when vibrated. 128 and 256 Hertz diapasons will be vibrated and placed in the patient's lateral epicondyle. The time that the patient feels vibration will be calculated with a chronometer.
Time Frame
Change from baseline vibration sensation at 3 weeks
Title
Ultrasonographic Imaging
Description
The lymphedema diagnoses of the patients will be confirmed by ultrasonographic imaging method routinely performed in the clinic. Imaging will be performed using a 5-12 MHz linear probe (Logiq P5, GE, Wisconsin, USA) on the upper extremity. Dermis and subcutaneous soft tissue thicknesses; It will be measured using plenty of gel, using images without applying any pressure - with the help of the device's automatic calculation feature after marking.
Time Frame
Change from baseline ultrasonographic imaging at 3 weeks.
Title
Environmental measurement
Description
The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.
Time Frame
Change from baseline environmental measurement at 3 weeks.
Title
Hot / Cold Sensory Test
Description
The sense of warm / cold will be evaluated with test tubes containing hot and cold liquid. The cold tube will be filled with water at 10 ° C and the hot tube at 40 ° C. When the patient's eyes are closed, these tubes will be touched to the skin surface 10 cm distal to the volar face elbow joint in a random order, and the patient will be asked to express that the water in the tube is hot or cold.
Time Frame
Change from baseline Hot/Cold sensory Test at 3 weeks
Title
Lymphedema Life Impact Scale
Description
Lymphedema Life Impact Scale: Weiss et al. The validity and reliability of the questionnaire developed by Orhan et al. made by. Lymphedema life impact scale consists of 18 questions and has physical, psychological and functional subtitles. '0'; no influence, '4'; It is scored between the minimum '0' and the maximum '72' score with a 5-stage Likert-type scale in the form of severe influence. As the score increases, the state of influence worsens.
Time Frame
Change from baseline Lymphedema Life Impact Scale at 3 weeks.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study was planned in women with breast cancer related lymphedema.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of lymphedema disease
Ages between 18-80 years old,
2 cm difference between the affected and unaffected arms in women with breast cancer related lymphedema,
At least 12 months after breast cancer treatments end and
Who are agreed to participate in the study.
Exclusion Criteria:
Women with active infection,
deep vein thrombosis/thrombophlebitis,
cardiac edema,
peripheral artery disease,
kidney, lung disease,
primary lymphedema,
peripheral upper limb nerve injury,
any surgery other than breast cancer surgeries,
existing shoulder, elbow, wrist, hand pathologies,
cooperation problems,
neurological disease,
mental illness, diabetes mellitus,
smoking and patients with open wounds on the upper limb.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emine Baran, PT, MSc
Phone
+903123052525
Ext
173
Email
eminekbaran@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Türkan Akbayrak, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Samanpazari
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Türkan Akbayrak, Prof
Phone
+903123052525
Ext
170
Email
takbayrak@yahoo.com
12. IPD Sharing Statement
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The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.
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