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Completed

NCT Number: NCT05776433

The Effects of Upper Extremity Lymphedema on Posture, Upper Extremity Functions, and Quality of Life

This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Dr. Nazif Bağrıaçık Kadıköy Hospital

Kadıköy, Istanbul, 34734, Turkey (Türkiye)

About this study

This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).

The hypotheses of our study:

Hypothesis 0 (H0):

There is no relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.

Hypothesis 1 (H1):

There is a relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteering to participate in the research
  • Be between the ages of 18-50
  • Having had unilateral breast cancer
  • At least one year since breast cancer treatment
  • No active metastases

Exclusion criteria

  • Arthritis
  • Fibromyalgia syndrome
  • Neurological diseases
  • Mental illnesses
  • Myopathic diseases
  • Bilateral upper extremity lymphedema
  • Inability to communicate and cooperate
  • Presence of any orthopaedic disease in the affected upper extremity
  • Having scoliosis
  • Having cognitive problems

Treatment and study plan

Primary outcomes

  1. Disabilities of the Arm, Shoulder, and Hand (DASH)

    Time frame: 10 minutes

    It is a disability/symptom scoring system based on a self-report system of 30 items developed to evaluate upper extremity-specific physical functions and symptoms. The DASH questionnaire, which consists of three parts, contains 30 questions. Of these, 21 questions evaluate the patient's difficulty during physical activity, five assess symptoms (pain, activity-related pain, tingling, weakness, difficulty in movement), and the remaining four evaluate the patient's social function, work, sleep, and self-confidence. Questions are scored from 1 to 5 (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: none at all). The total score is between 0-100. The DASH score is calculated using the formula [sum of answers/n-1] x 25 (n=number of questions answered).

  2. Lymphedema Functionality, Disability, and Health Questionnaire (Lymph-ICF)

    Time frame: 10 minutes

    Lymph-ICF, a descriptive and evaluation tool, consists of 29 questions about the functional impairments, activity limitations, and participation restrictions reported by patients with breast cancer-related lymphedema. Physical function, mental function, home activities, mobility activities, and life and social activities are the five main components into which the questionnaire is subdivided. There is a visual analogue scale next to each question, and the patient marks the answer that suits themself. While calculating the survey score, the score of each subsection is found by summing and dividing by the number of questions answered. The total score is obtained by adding the scores of the subsections. A high score indicates that the effect on the quality of life is high.

  3. Upper Extremity Lymphedema-27 (ULL-27)

    Time frame: 10 minutes

    ULL-27 is a quality-of-life questionnaire evaluating upper extremity lymphedema as three components. The scale deals with physical, psychological and social components and consists of 27 questions. A 5-point Likert score (1=strongly disagree, 5=strongly agree) is used in the scale. The first 15 questions evaluate the physical component, questions between 16-22 evaluate the psychological component, and questions between 23-27 evaluate the social component. The lowest score is 27, and the highest score is 135. A high score on the scale indicates that lymphedema negatively affects the quality of life. The physical score consists of a total of fifteen questions, and this score of the person is between min 15 and 75. The psychological score consists of seven questions, with a minimum of 7 and a maximum of 35 points. There are five questions for the social score, with a minimum of 5 and a maximum of 25 points.

  4. Quality of Life Measure for Limb Lymphedema-Arm (LYMQOL-Arm)

    Time frame: 10 minutes

    The LYMQOL-Arm, primarily as a self-assessment report questionnaire assessing the symptoms of lymphedema in the upper extremity and the ability to perform functional activities in patients with breast cancer-associated lymphedema. There are five subsections in the 21-question survey. These are upper extremity function (questions 1a-h,2,3), appearance (questions 4-8), symptoms (questions 9-14), emotional state (questions 15-20), and general quality of life ( 21st question). In the first 20 questions, there are four options for each question: none (1 point), a little (2 points), quite (3 points), and a lot (4 points). The scores of these subsections are summed up within themselves and divided by the number of questions answered. In the 21st question, the patient is asked to give a value between 0 and 10 for the quality of life. High scores for the first 20 questions and low scores for the 21st question indicate poor quality of life.

  5. The New York Posture Analysis (NYPA)

    Time frame: 5 minutes

    Posture is the optimal form of all body parts about the whole body and the adjacent segment. This assessment test evaluates posture disorders that occur in 13 different body regions. The scoring of the test is as follows; A score of 5 is given if the person has a proper posture, 3 points if there is a moderate impairment, and 1 point if there is a severe disorder. The maximum score obtained at the end of the test is 65, and the minimum is 13. The standard evaluation criteria developed for the test are as follows for the total score; >=45: very good, 40-44: good, 30-39: medium, 20-29: weak, <=19:bad

Other outcomes

  1. Upper Extremity Circumference Measurement

    Time frame: 1 hour

    Circumference measurements were evaluated for both upper extremities. Markings were made every 4 cm, assuming the wrist pivot point. Upper extremity circumference measurements were made at 4 cm intervals up to the axilla. The difference between the affected and healthy sides was determined.

  2. Goniometric Measurements

    Time frame: 1 hour

    The active range of motion (ROM) of both shoulders (affected and healthy) was measured with a goniometer. Flexion and abduction were measured in the supine position and extension in the prone position. Internal and external rotations were measured in the supine position with the shoulder 90° abducted and the elbow 90° flexion. A difference of ≥20° between the affected and unaffected sides was considered a limitation in the ROM of the affected side.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

The Effects of Extremity With Lymphedema on Posture, Upper Extremity Functions, and Quality of Life in Patients With Lymphedema After Unilateral Breast Cancer

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2023
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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