The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.

March 3, 2020 updated by: Emine BARAN, Hacettepe University

The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Samanpazari
      • Ankara, Samanpazari, Turkey, 06100
        • Recruiting
        • Hacettepe University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Affected arm in lymphedema patients
Complex decongestive physiotherapy treatment will be applied to the arm (affected arm) that develops lymphedema after unilateral breast cancer treatment.
Other: Complex Decongestive Physiotherapy
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.
NO_INTERVENTION: Unaffected arm in lymphedema patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Touching sensation
Time Frame: Change from Baseline touching sensation at 3 weeks
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.
Change from Baseline touching sensation at 3 weeks
Two-point discrimination
Time Frame: Change from baseline two-point discrimination at 3 weeks
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.
Change from baseline two-point discrimination at 3 weeks
Pressure pain threshold
Time Frame: Change from baseline pressure pain threshold at 3 weeks
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.
Change from baseline pressure pain threshold at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vibration sensation
Time Frame: Change from baseline vibration sensation at 3 weeks
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.
Change from baseline vibration sensation at 3 weeks
Ultrasonographic Imaging
Time Frame: Change from baseline ultrasonographic imaging at 3 weeks.
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.
Change from baseline ultrasonographic imaging at 3 weeks.
Environmental measurement
Time Frame: Change from baseline environmental measurement at 3 weeks.
The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.
Change from baseline environmental measurement at 3 weeks.
Hot / Cold Sensory Test
Time Frame: Change from baseline Hot/Cold sensory Test at 3 weeks
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.
Change from baseline Hot/Cold sensory Test at 3 weeks
Lymphedema Life Impact Scale
Time Frame: Change from baseline Lymphedema Life Impact Scale at 3 weeks.
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.
Change from baseline Lymphedema Life Impact Scale at 3 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Türkan Akbayrak, Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2019

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (ACTUAL)

March 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBaran

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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