Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema

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?

Study Overview

• Status: Recruiting
• Conditions: Pain; Breast Cancer; Lymphedema; Myofascial Pain Syndrome; Breast Cancer Female; Lymphedema of Upper Limb
• Intervention / Treatment: Diagnostic test: Diagnostic Criteria of Myofascial Pain Syndrome; Diagnostic test: The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer; Diagnostic test: Hand Grip Test; Diagnostic test: VAS; Diagnostic test: Quick DASH; Diagnostic test: Lymqol-Arm; Diagnostic test: Range of Motion of Shoulde Joint

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).

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Özden Tömek, MD; Phone Number: Turkey: +905343284941; Email: ozden.tomek@gmail.com
• Study Contact Backup: Name: Gökçenur Yalçın, MD; Phone Number: +905301413290; Email: gokce_cihaner@hotmail.com

Study Locations

• Turkey
  • Kadıköy
    • İstanbul, Kadıköy, Turkey, 34668
      • Recruiting
      • Sultan 2. Abdulhamid Han Training and Research Hospital
      • Contact: Özden Tömek, MD; Phone Number: Turkey: +905343284941; Email: ozden.tomek@gmail.com
      • Contact: Gökçenur Yalçın, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (Patients with Stage 0 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)	Diagnostic test: Diagnostic Criteria of Myofascial Pain Syndrome; Major criteria: The patient's complaint of regional pain; Referred pain and sensory change in the specific area of the muscle by palpation of the trigger point; Presence of palpable taut band; Presence of palpable and tender points along the length of the taut band; Restriction of ROM in the area of the affected muscle Minor criteria: Pain/sensory change with pressure palpation of the trigger point; Local twitch response with palpation/injection of the trigger point in the taut band; Reduction of pain by inactivation (injection or stretching of the muscle) of the trigger point 5 major and at least 1 minor criteria are required for clinical diagnosis; Diagnostic test: The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer; Trigger points in trapezius, infraspinatus, latissimus dorsi, pectoralis major, serratus anterior muscles will be detected bilaterally by physical examination. Algometer (Wagner Force Dial FDK 20) will be used for pain pressure threshold measurement of detected trigger points. Then, the distribution of the trigger points, their frequency and threshold values according to the algometer will be compared between the individual affected-insured extremities and between the groups.; Diagnostic test: Hand Grip Test; The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 5 minutes. The test will be repeated for both upper extremities separately.; Diagnostic test: VAS; Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.; Diagnostic test: Quick DASH; The quick DASH questionnaire which has proven reliable and valid in breast cancer and lymphedema patients in Turkish population, will be used to evaluate the quality of life related to upper extremity function.; Diagnostic test: Lymqol-Arm; Lymphedema Quality of Life Scale-Arm Turkish form will be used. The lymphedema-specific quality of life scale was developed specifically for the upper extremity and its reliability and validity were proven in Turkish population.; Diagnostic test: Range of Motion of Shoulde Joint; Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.
Group 2 (Patients with Stage 1,2 or 3 lymphedema); 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)	Diagnostic test: Diagnostic Criteria of Myofascial Pain Syndrome; Major criteria: The patient's complaint of regional pain; Referred pain and sensory change in the specific area of the muscle by palpation of the trigger point; Presence of palpable taut band; Presence of palpable and tender points along the length of the taut band; Restriction of ROM in the area of the affected muscle Minor criteria: Pain/sensory change with pressure palpation of the trigger point; Local twitch response with palpation/injection of the trigger point in the taut band; Reduction of pain by inactivation (injection or stretching of the muscle) of the trigger point 5 major and at least 1 minor criteria are required for clinical diagnosis; Diagnostic test: The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer; Trigger points in trapezius, infraspinatus, latissimus dorsi, pectoralis major, serratus anterior muscles will be detected bilaterally by physical examination. Algometer (Wagner Force Dial FDK 20) will be used for pain pressure threshold measurement of detected trigger points. Then, the distribution of the trigger points, their frequency and threshold values according to the algometer will be compared between the individual affected-insured extremities and between the groups.; Diagnostic test: Hand Grip Test; The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 5 minutes. The test will be repeated for both upper extremities separately.; Diagnostic test: VAS; Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.; Diagnostic test: Quick DASH; The quick DASH questionnaire which has proven reliable and valid in breast cancer and lymphedema patients in Turkish population, will be used to evaluate the quality of life related to upper extremity function.; Diagnostic test: Lymqol-Arm; Lymphedema Quality of Life Scale-Arm Turkish form will be used. The lymphedema-specific quality of life scale was developed specifically for the upper extremity and its reliability and validity were proven in Turkish population.; Diagnostic test: Range of Motion of Shoulde Joint; Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Evaluation of Trigger Points	Trigger points in trapezius, infraspinatus, latissimus dorsi, pectoralis major, serratus anterior muscles will be detected bilaterally by physical examination. Algometer (Wagner Force Dial FDK 20) will be used for pain pressure threshold measurement of detected trigger points. Then, the distribution of the trigger points, their frequency and threshold values according to the algometer will be compared between the individual affected-insured extremities and between the groups.	3 days
Clinical Diagnostic Criteria of Myofascial Pain Syndrome	Major criteria: 1. The patient's complaint of regional pain 2. Referred pain and sensory change in the specific area of the muscle by palpation of the trigger point 3. Presence of palpable taut band 4. Presence of palpable and tender points along the length of the taut band 5. Restriction of ROM in the area of the affected muscle Minor criteria: 1. Pain/sensory change with pressure palpation of the trigger point 2. Local twitch response with palpation/injection of the trigger point in the taut band 3. Reduction of pain by inactivation (injection or stretching of the muscle) of the trigger point 5 major and at least 1 minor criteria are required for clinical diagnosis	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Grip Test	The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 5 minutes. The test will be repeated for both upper extremities separately.	3 days
Range of motion of shoulder joint	Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.	3 days
VAS	Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.	3 days
Quick-DASH (The Disabilities of the Arm, Shoulder and Hand)	The quick DASH questionnaire which has proven reliable and valid in breast cancer and lymphedema patients in Turkish population, will be used to evaluate the quality of life related to upper extremity function.	3 days
LYMQOL-arm (Lymphedema Quality of Life -arm)	Lymphedema Quality of Life Scale-Arm Turkish form will be used. The lymphedema-specific quality of life scale was developed specifically for the upper extremity and its reliability and validity were proven in Turkish population.	3 days

Collaborators and Investigators

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Investigators: Principal Investigator: Yeliz Bahar Özdemir

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; myofascial pain syndrome; lymphedema
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Disease; Breast Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Breast Neoplasms; Lymphedema; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Breast Cancer Lymphedema
• Other Study ID Numbers: 23/338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No