Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06012786
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-08-22
Brief Title:
Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
Sponsor:
Sultan Abdulhamid Han Training and Research Hospital Istanbul Turkey
Organization:
Sultan Abdulhamid Han Training and Research Hospital Istanbul Turkey
Study Overview
Official Title:
Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 n55 Patients who have more than 3 cm difference between the circumference measurements of upper extremities and those with Stage 12 or 3 lymphedema will be included in the second group n55 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 200 IBM Corp Armonk NY USA
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 andor 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 n55 Patients who have more than 3 cm difference between the circumference measurements of upper extremities and those with Stage 12 or 3 lymphedema will be included in the second group n55 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 200 IBM Corp Armonk NY USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None