AzTrials
AzTrials

Myofascial Pain SyndromeNCT06012786

Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema

An observational study of Myofascial Pain Syndrome and Breast Cancer, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Diagnostic Criteria of Myofascial Pain Syndrome, The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer and Hand Grip Test
Type of treatment
Injection or infusion
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Aug 2023to 20 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sultan 2. Abdulhamid Han Training and Research Hospital

    Istanbul, Kadıköy, 34668

Other trials in Turkey (Türkiye)

About this study

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?
Read the 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).

Being tested
Diagnostic Criteria of Myofascial Pain Syndrome, The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer, Hand Grip Test, VAS, Quick DASH
Keywords
breast cancer, myofascial pain syndrome, lymphedema
Medical subject headings
Myofascial Pain Syndromes, Breast Neoplasms, Lymphedema, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic Criteria of Myofascial Pain SyndromeDiagnostic test

    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
  • The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an AlgometerDiagnostic test

    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 TestDiagnostic 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.

  • VASDiagnostic test

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

  • Quick DASHDiagnostic test

    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-ArmDiagnostic test

    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 JointDiagnostic test

    Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.

Study groups in NCT06012786
Study groupRoleWhat they receive
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)
Receives: 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
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)
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 days

  2. 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

    Measured: 3 days

Secondary outcomes (5)
  1. 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.

    Measured: 3 days

  2. 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.

    Measured: 3 days

  3. VAS

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

    Measured: 3 days

  4. 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.

    Measured: 3 days

  5. 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.

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2023
  2. Study start30 Aug 2023
  3. Primary completion30 Aug 2024
  4. Study completion20 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06012786
Sponsor's protocol ID
23/338
Status last verified
Sep 2025
First submitted
22 Aug 2023
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Myofascial Pain Syndrome and Breast Cancer, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Evaluation of Trigger Points (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in