Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema

Breast Cancer Clinical Trial

Official title:

Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012786
• Other study ID #: 23/338
• Status: Recruiting
• Start date: August 30, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Özden Tömek, MD
• Phone: Turkey: +905343284941
• Email: ozden.tomek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Cancer Lymphedema
• Breast Neoplasms
• Fibromyalgia
• Lymphedema
• Lymphedema of Upper Limb
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Pain
• Somatoform Disorders
• Syndrome

Intervention

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
• 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.
• 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.
• VAS
Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Sultan 2. Abdulhamid Han Training and Research Hospital	Istanbul	Kadiköy

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	VAS	Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.	3 days
Secondary	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
Secondary	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