The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.
NCT ID: NCT04296929
Last Updated: 2020-03-05
Study Results
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Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-11-28
2021-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
FEMALE
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Emine BARAN
Research Assistant, Physical Therapist, Master of Science
Principal Investigators
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Türkan Akbayrak, Prof
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University
Locations
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Hacettepe University
Ankara, Samanpazari, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Ribeiro Pereira ACP, Koifman RJ, Bergmann A. Incidence and risk factors of lymphedema after breast cancer treatment: 10 years of follow-up. Breast. 2017 Dec;36:67-73. doi: 10.1016/j.breast.2017.09.006. Epub 2017 Oct 6.
Rijke AM, Croft BY, Johnson RA, de Jongste AB, Camps JA. Lymphoscintigraphy and lymphedema of the lower extremities. J Nucl Med. 1990 Jun;31(6):990-8.
Goyal A, Newcombe RG, Chhabra A, Mansel RE. Morbidity in breast cancer patients with sentinel node metastases undergoing delayed axillary lymph node dissection (ALND) compared with immediate ALND. Ann Surg Oncol. 2008 Jan;15(1):262-7. doi: 10.1245/s10434-007-9593-3. Epub 2007 Sep 19.
Wu SG, Huang SJ, Zhou J, Sun JY, Guo H, Li FY, Lin Q, Lin HX, He ZY. Dosimetric analysis of the brachial plexus among patients with breast cancer treated with post-mastectomy radiotherapy to the ipsilateral supraclavicular area: report of 3 cases of radiation-induced brachial plexus neuropathy. Radiat Oncol. 2014 Dec 12;9:292. doi: 10.1186/s13014-014-0292-5.
Warmuth MA, Bowen G, Prosnitz LR, Chu L, Broadwater G, Peterson B, Leight G, Winer EP. Complications of axillary lymph node dissection for carcinoma of the breast: a report based on a patient survey. Cancer. 1998 Oct 1;83(7):1362-8. doi: 10.1002/(sici)1097-0142(19981001)83:73.0.co;2-2.
Andersen KG, Duriaud HM, Kehlet H, Aasvang EK. The Relationship Between Sensory Loss and Persistent Pain 1 Year After Breast Cancer Surgery. J Pain. 2017 Sep;18(9):1129-1138. doi: 10.1016/j.jpain.2017.05.002. Epub 2017 May 11.
Say CC, Donegan W. A biostatistical evaluation of complications from mastectomy. Surg Gynecol Obstet. 1974 Mar;138(3):370-6. No abstract available.
Ganel A, Engel J, Sela M, Brooks M. Nerve entrapments associated with postmastectomy lymphedema. Cancer. 1979 Dec;44(6):2254-9. doi: 10.1002/1097-0142(197912)44:63.0.co;2-9.
Foldi M, Foldi E. [Therapy of lymphedema]. Med Welt. 1980 May 23;31(21):801-6. No abstract available. German.
Lim CY, Seo HG, Kim K, Chung SG, Seo KS. Measurement of lymphedema using ultrasonography with the compression method. Lymphology. 2011 Jun;44(2):72-81.
Voerman VF, van Egmond J, Crul BJ. Normal values for sensory thresholds in the cervical dermatomes: a critical note on the use of Semmes-Weinstein monofilaments. Am J Phys Med Rehabil. 1999 Jan-Feb;78(1):24-9. doi: 10.1097/00002060-199901000-00007.
MOBERG E. Objective methods for determining the functional value of sensibility in the hand. J Bone Joint Surg Br. 1958 Aug;40-B(3):454-76. doi: 10.1302/0301-620X.40B3.454. No abstract available.
Dellon AL. The moving two-point discrimination test: clinical evaluation of the quickly adapting fiber/receptor system. J Hand Surg Am. 1978 Sep;3(5):474-81. doi: 10.1016/s0363-5023(78)80143-9.
Granges G, Littlejohn G. Pressure pain threshold in pain-free subjects, in patients with chronic regional pain syndromes, and in patients with fibromyalgia syndrome. Arthritis Rheum. 1993 May;36(5):642-6. doi: 10.1002/art.1780360510.
Weiss J, Daniel T. VALIDATION OF THE LYMPHEDEMA LIFE IMPACT SCALE (LLIS): A CONDITION-SPECIFIC MEASUREMENT TOOL FOR PERSONS WITH LYMPHEDEMA. Lymphology. 2015 Sep;48(3):128-38.
Orhan C, Uzelpasaci E, Baran E, Nakip G, Ozgul S, Aksoy S, Akbayrak T. The Reliability and Validity of the Turkish Version of the Lymphedema Life Impact Scale in Patients With Breast Cancer-Related Lymphedema. Cancer Nurs. 2020 Sep/Oct;43(5):375-383. doi: 10.1097/NCC.0000000000000709.
Baran E, Ozcakar L, Ozgul S, Aksoy S, Akbayrak T. Upper limb sensory evaluations and ultrasonographic skin measurements in breast cancer-related lymphedema receiving complex decongestive physiotherapy. Support Care Cancer. 2021 Nov;29(11):6545-6553. doi: 10.1007/s00520-021-06235-4. Epub 2021 Apr 29.
Other Identifiers
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EBaran
Identifier Type: -
Identifier Source: org_study_id
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