Clinical trial NCT06012786: Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
Official title: Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myofascial Pain Syndrome
Breast Cancer
Breast Cancer Female
Lymphedema
Lymphedema of Upper Limb
Pain
Keywords: breast cancer
myofascial pain syndrome
lymphedema
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer patients aged between 18-75 years old, who had undergone the treatments as mastectomy, breast conserving surgery, lymph node dissection, sentinele lymph node biopsy or radiotherapy visiting our oncological rehabilitation outpatient clinic between August 2023 and May 2024.

Brief summary: The goal of this observational study is to determine the relationship between Lymphedema and Myofascial Pain Syndrome in Breast Cancer Patients.

The main questions it aims to answer:

* Is there a relationship between the stage of lymphedema and the frequency of accompanying myofascial pain syndrome in the breast cancer patients?
* Does the existence of lymphedema in breast cancer patients affect the distribution and the pain threshold values of trigger points seen in Myofascial Pain Syndrome?
* What is the impact of Myofascial pain syndrome seen in breast cancer associted lymhedema patients on upper extremity function and quality of life?

Detailed description: Mastectomy, breast conserving surgery, axillary lymph node dissection, sentinel lymph node biopsy and radiotherapy treatments have significant results in skin, muscle and fascia tissues in the upper extremity.

Upper extremity function is defined by the International Consortium for Measures of Health Outcomes (ICHOM) as one of the most important health measures in breast cancer patients. Long-term upper extremity dysfunction has serious effects on patients' quality of life.

Lymphedema, severe pain, decrease in shoulder joint range of motion, myofascial pain syndrome, myofascial adhesions are the leading causes affecting upper extremity function in patients with breast cancer.

Myofascial pain syndrome (MPS) is commonly seen in patients with musculoskeletal problems and originates from muscle and surrounding tissues. It is characterized by localized or referred pain in a limited area and trigger points in the affected muscles. The incidence of myofascial pain syndrome secondary to breast cancer surgery is unknown. There is not yet a study in the literature that reveals the relationship between the stage of lymphedema and the frequency of accompanying myofascial pain syndrome in the breast cancer patients.

This study is designed as cross sectional- single centered and single blind. It is planned to include 110 breast cancer patients who had undergone the treatments as mastectomy, breast conserving surgery, lymph node dissection, sentinele lymph node biopsy or radiotherapy aged between 18-75 years-old, visiting our oncological rehabilitation outpatient clinic August 2023 through May 2024.

Patients will be divided into 2 groups according to the stage of lymphedema. It is known that pathophysiological changes develop even if there is no visible lymphedema in patients undergoing surgery and/or radiotherapy for breast cancer. There is a lifetime risk of developing lymphedema, so these patients are considered as Stage 0 (latent) . The patients with less than 3 cm difference between the circumference measurements of upper extremities will be included in the 1st group.( Stage 0) (n=55) Patients who have more than 3 cm difference between the circumference measurements of upper extremities and those with Stage 1,2 or 3 lymphedema will be included in the second group (n=55) The frequency of myofascial pain syndrome will be determined by the diagnostic criterias in both groups. The trigger points in trapezius, infraspinatus, serratus anterior, latissimus dorsi and pectoralis major muscles will be examined and the pain-pressure threshold values will be measured with an algometer.

For the evaluation of upper extremity function and quality of life following measurement tools will be utilized in both groups: Hand-grip test with a dynamometer, goniometric measurement of range of motion (ROM) of shoulder joint, VAS numerical scales, LYMQOL and DASH questionnaires.

Data analysis will be performed by using the Statistical Package for the Social Sciences (SPSS, version 20.0, IBM Corp., Armonk, NY, USA).

Eligibility criteria: Inclusion Criteria :

* Breast cancer patients aged between 18-75 who had undergone the treatments as mastectomy, breast conserving surgery, lymph node dissection, sentinele lymph node biopsy or radiotherapy providing a written consent to participate in the study

Exclusion Criteria :

* Patients who do not agree to participate the study
* Patients who had signs of active infection as lymphangitis, cellulitis, fungus
* Bilateral breast cancer patients
* Uncontrolled Psychiatric illness

Primary outcomes:
measure: The Evaluation of Trigger Points
timeFrame: 3 days
measure: Clinical Diagnostic Criteria of Myofascial Pain Syndrome
timeFrame: 3 days
Secondary outcomes:
measure: Hand Grip Test
timeFrame: 3 days
measure: Range of motion of shoulder joint
timeFrame: 3 days
measure: VAS
timeFrame: 3 days
measure: Quick-DASH (The Disabilities of the Arm, Shoulder and Hand)
timeFrame: 3 days
measure: LYMQOL-arm (Lymphedema Quality of Life -arm)
timeFrame: 3 days
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sultan 2. Abdulhamid Han Training and Research Hospital
state: Kadıköy
Study officials:
name: Yeliz Bahar Özdemir
role: PRINCIPAL_INVESTIGATOR
References: