Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
1 other identifier
observational
110
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedStudy Start
First participant enrolled
August 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2025
CompletedSeptember 12, 2025
September 1, 2025
1 year
August 22, 2023
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Hand Grip Test
3 days
Range of motion of shoulder joint
3 days
VAS
3 days
Quick-DASH (The Disabilities of the Arm, Shoulder and Hand)
3 days
LYMQOL-arm (Lymphedema Quality of Life -arm)
3 days
Study Arms (2)
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)
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)
Interventions
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
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.
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.
Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.
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.
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.
Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Kadıköy, 34668, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yeliz Bahar Özdemir
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2023
First Posted
August 25, 2023
Study Start
August 30, 2023
Primary Completion
August 30, 2024
Study Completion
February 20, 2025
Last Updated
September 12, 2025
Record last verified: 2025-09