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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296929
• Other study ID #: EBaran
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2020
• Source: Hacettepe University
• Contact: Emine Baran, PT, MSc
• Phone: +903123052525
• Email: eminekbaran[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema of Upper Arm

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Samanpazari

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

Földi M, Földi E. [Therapy of lymphedema]. Med Welt. 1980 May 23;31(21):801-6. Review. German. — View Citation

Ganel A, Engel J, Sela M, Brooks M. Nerve entrapments associated with postmastectomy lymphedema. Cancer. 1979 Dec;44(6):2254-9. — View Citation

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. Epub 2007 Sep 19. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Orhan C, Üzelpasaci E, Baran E, Nakip G, Özgül 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. 2019 Mar 28. doi: 10.1097/NCC.0000000000000709. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Say CC, Donegan W. A biostatistical evaluation of complications from mastectomy. Surg Gynecol Obstet. 1974 Mar;138(3):370-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline touching sensation at 3 weeks
Primary	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.	Change from baseline two-point discrimination at 3 weeks
Primary	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.	Change from baseline pressure pain threshold at 3 weeks
Secondary	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.	Change from baseline vibration sensation at 3 weeks
Secondary	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.	Change from baseline ultrasonographic imaging at 3 weeks.
Secondary	Environmental measurement	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.
Secondary	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.	Change from baseline Hot/Cold sensory Test at 3 weeks
Secondary	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.	Change from baseline Lymphedema Life Impact Scale at 3 weeks.