Trial Title:
Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
NCT ID:
NCT06012786
Condition:
Myofascial Pain Syndrome
Breast Cancer
Breast Cancer Female
Lymphedema
Lymphedema of Upper Limb
Pain
Conditions: Official terms:
Breast Neoplasms
Myofascial Pain Syndromes
Fibromyalgia
Lymphedema
Breast Cancer Lymphedema
Syndrome
Somatoform Disorders
Conditions: Keywords:
breast cancer
myofascial pain syndrome
lymphedema
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Diagnostic Criteria of Myofascial Pain Syndrome
Description:
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
Arm group label:
Group 1 (Patients with Stage 0 lymphedema)
Arm group label:
Group 2 (Patients with Stage 1,2 or 3 lymphedema)
Intervention type:
Diagnostic Test
Intervention name:
The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer
Description:
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.
Arm group label:
Group 1 (Patients with Stage 0 lymphedema)
Arm group label:
Group 2 (Patients with Stage 1,2 or 3 lymphedema)
Intervention type:
Diagnostic Test
Intervention name:
Hand Grip Test
Description:
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.
Arm group label:
Group 1 (Patients with Stage 0 lymphedema)
Arm group label:
Group 2 (Patients with Stage 1,2 or 3 lymphedema)
Intervention type:
Diagnostic Test
Intervention name:
VAS
Description:
Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated
separately by numerical scale.
Arm group label:
Group 1 (Patients with Stage 0 lymphedema)
Arm group label:
Group 2 (Patients with Stage 1,2 or 3 lymphedema)
Intervention type:
Diagnostic Test
Intervention name:
Quick DASH
Description:
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.
Arm group label:
Group 1 (Patients with Stage 0 lymphedema)
Arm group label:
Group 2 (Patients with Stage 1,2 or 3 lymphedema)
Intervention type:
Diagnostic Test
Intervention name:
Lymqol-Arm
Description:
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.
Arm group label:
Group 1 (Patients with Stage 0 lymphedema)
Arm group label:
Group 2 (Patients with Stage 1,2 or 3 lymphedema)
Intervention type:
Diagnostic Test
Intervention name:
Range of Motion of Shoulde Joint
Description:
Goniometric measurements will be made for both upper extremities, and the average of 3
consecutive measurements will be taken.
Arm group label:
Group 1 (Patients with Stage 0 lymphedema)
Arm group label:
Group 2 (Patients with Stage 1,2 or 3 lymphedema)
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).
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Gender based:
Yes
Gender description:
Female Breast Cancer Patients
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sultan 2. Abdulhamid Han Training and Research Hospital
Address:
City:
İstanbul
Zip:
34668
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Özden Tömek, MD
Phone:
Turkey: +905343284941
Email:
ozden.tomek@gmail.com
Contact backup:
Last name:
Gökçenur Yalçın, MD
Start date:
August 30, 2023
Completion date:
August 30, 2024
Lead sponsor:
Agency:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Agency class:
Other
Source:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06012786
