Breast Cancer SurvivorsNCT05386628
The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors
A study testing conventional physiotherapy, Manual lymphatic drainage and Myofascial relasing in people with Breast Cancer Survivors, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
In breast cancer patients, limitation of shoulder joint movement occurs following mastectomy surgery. Studies have reported that damage to the fascia on the pectoralis major muscle during mastectomy surgery contributes to the development of the limitation. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- conventional physiotherapy, Manual lymphatic drainage and Myofascial relasing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 1 May 2025
- Phase
- Interventional
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the ages of 30-60
- Having breast surgery within 2 years
- Not have received conservative treatment for shoulder rehabilitation in the last 6 months
- Having limitation of movement of the shoulder joint due to breast surgery
Who cannot join
- Not having agreed to participate in the study
- Having undergone radical mastectomy surgery
- Having connective tissue disease
- Presence of brachial plexus paresis/plegia
- Presence of radiogenic fibrosis
- Presence of additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect upper extremity functions
Show all 13Show fewer
- Presence of active metastases
- Having undergone reconstruction surgery
- Continuation of radiotherapy (must have ended at least 3 months ago) or chemotherapy applications
- Having had a bilateral mastectomy
- To develop lymphedema in the arm-trunk
- Use of muscle relaxants
- Patients with severe chemotherapy side effects (hyperesthesia, nausea, skin changes, weakness, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion Following Mastectomy Surgery in Breast Cancer Survivors
In breast cancer patients, limitation of shoulder joint movement occurs following mastectomy surgery. Studies have reported that damage to the fascia on the pectoralis major muscle during mastectomy surgery contributes to the development of the limitation. The aim of this study is to investigate the effect of release techniques applied to the fascia on the pectoralis major muscle and the fascial chain on the incerasing of shoulder joint range of motion.
Read the detailed description
After mastectomy, complications such as decreased range of motion and muscle strength in the shoulder joint, development of pain and tenderness, and formation of lymphedema are frequently observed. In addition to causing a significant decrease in the patient's daily life quality, shoulder limitation also negatively affects the treatment process by preventing the joint position required for radiotherapy. For this reason, it is a priority to prevent the development of shoulder joint limitations that may occur following surgery and to open the developing limitation immediately. This study was born from the idea that the relaxation techniques to be applied to regain the mobility of the fascial structure, which has been damaged and whose mobility has decreased due to breast surgery, should be performed by covering the entire myofascial chain. In addition, the investigators aim to prevent adhesions that will limit the mobility of soft tissue by minimizing scar tissue formation with early drainage of postoperative edema. The aim of this study is to investigate the effectiveness of myofascial chain relaxation techniques and manual lymphatic drainage applied to improve soft tissue mobility in the prevention and elimination of shoulder limitations after breast cancer surgery.
A total of 48 patients who agreed to participate in the study will be enrolled in the treatment program twice a week for 6 weeks. During the study, the same assessments will be applied to all patients and the cases will be evaluated 3 times (pre-treatment, post treatment, and one month post treatment). During the assessments, the physical evaluations of the patients on the shoulder region will be examined in detail using objective and subjective methods.
- Conditions
- Breast Cancer Survivors
- Being tested
- conventional physiotherapy, Manual lymphatic drainage, Myofascial relasing
- Keywords
- breast cancer, range of motion, lymphatic drainage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapyOther
A basic physiotherapy program consisting of shoulder exercises will be applied to the participants.
content of the physiotherapy program
- Shoulder passive/active abduction, flexion, internal and external rotation exercises
- Posture exercises
- Neck stretching exercises
- Pectoralis major stretching exercises
- Shoulder capsule stretching exercises
- Scapular Mobilization exercises
Manual lymphatic drainageOther
manual lymph drainage is a manual technique that is applied to the lymphatic system with a pressure of 40-50 mmHg and increases the working speed of lymphatic nodules/collectors. Manual lymph drainage will be made to the anterior axillar-axillar, posterior axillar-axillar and axilla-inguinal anastomosis collectors and the arm region (up to the elbow) lymph collectors.
Myofascial relasingOther
it will be done with the thumb or 3rd finger from the acu points of the superficial arm-anterior myofascial chain. 6-8 seconds with thumb to these points. pressure will be applied and vibration will be given clockwise.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Conventional physiotherapy program (joint movement exercises, local relaxation techniques, etc.) will be applied to the participants in this group. Receives: Other: conventional physiotherapy |
| Manual lymphatic drainage group | Experimental | In addition to the conventional physiotherapy program, manual lymphatic drainage (including upper limb extremity and anterior/posterior axillar-axillar anastomoses and axilla-inguinal anastomosis) will be applied to the participants in this group. Receives: Other: conventional physiotherapy; Other: Manual lymphatic drainage |
| Myofascial relasing group | Experimental | In addition to the conventional physiotherapy program, myofascial chain relasing techniques will be applied to the participants in this group. Receives: Other: conventional physiotherapy; Other: Myofascial relasing |
| Lymphatic drainage and myofascial releasing group | Experimental | In addition to the conventional physiotherapy program, manual lymphatic drainage (including upper limb extremity and anterior/posterior axillar-axillar anastomoses and axilla-inguinal anastomosis) and myofascial chain relasing techniques will be applied to the participants in this group. Receives: Other: conventional physiotherapy; Other: Manual lymphatic drainage; Other: Myofascial relasing |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of tissue stiffness (N/m)
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain .
Measured: changes from baseline stiffness values will be measured at 6 week and 10 week
measurement of passive muscle tone (Hz)
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
Measured: changes from baseline tone values will be measured at 6 week and 10 week
measurement of creep of tissue
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
Measured: changes from baseline creep values will be measured at 6 week and 10 week
measurement of the range of shoulder joint motion
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
Measured: changes from baseline range of the shoulder joint motion values will be measured at 6 week and 10 week
assessment of activity of daily living
upper extremity daily living functional capacity of participation will be assessed with the Quick-DASH (Shortened Disabilities Arm, Shoulder and Hand Questionnaire). The scale consists of 11 items. In the scale, a 5-point Likert scale is evaluated and scored 1-5. The scores that can be obtained from the scale are between 0-100. Lower scores indicate better daily activity participation.
Measured: changes from baseline Quick-DASH Questionnaire scores will be assessment at 6 week and 10 week
assessment of depression and anxiety
quality of life will be assessed using the Hospital Anxiety and Depression Scale (HAD). The scale consists of 14 items (7 items depression and 7 items anxiety). The scale is evaluated on a 4-point Likert scale and is scored 0-3. Depression and anxiety scores are calculated separately. While the score range that can be taken in the lower scales is 0-21, low scores are considered positive.
Measured: changes from baseline HAD scale scores will be assessment at 6 week and 10 week
Secondary outcomes (4)
measurement of skin temperature
measurements will be taken from the area covering 3 cm of the surgical incision with a P45 thermographic camera with high thermal sensitivity (Flir Sistem, ThermaCAM, Sweden).
Measured: changes from baseline skin temperature values will be measured at 6 week and 10 week
measurement of pain
Pain will be evaluated by visual analog scale (VAS). In the scale, the patient is asked to mark the most appropriate pain intensity on a scale ranging from 0 (no pain) to 10 (tolerable pain). The higher the score, the greater the pain intensity.
Measured: changes from baseline pain values will be measured at 6 week and 10 week
measurement of pain pressure threshold
Pain pressure threshold will be evaluated by a digital algometer (Algometer Commander, Jtech Medical, MM036_K, 2016).
Measured: changes from baseline pain pressure threshold values will be measured at 6 week and 10 week
measurement of grip strength
The grip strength of both hand will be evaluated by "hand-held" dynamometer.
Measured: changes from baseline grip strength values will be measured at 6 week and 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start15 Aug 2022
- Primary completion15 Jan 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilufer Kablan, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386628
- Sponsor's protocol ID
- 2022/0132
- Status last verified
- Jul 2026
- First submitted
- 18 May 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion Following Mastectomy Surgery in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05386628
- Acronym / sponsor ID
- 2022/0132
- Conditions
- Breast Cancer Survivors
- Keywords
- breast cancer, range of motion, lymphatic drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In breast cancer patients, limitation of shoulder joint movement occurs following mastectomy surgery. Studies have reported that damage to the fascia on the pectoralis major muscle during mastectomy surgery contributes to the development of the limitation. The aim of this study is to investigate the effect of release techniques applied to the fascia on the pectoralis major muscle and the fascial chain on the incerasing of shoulder joint range of motion.
Detailed description
After mastectomy, complications such as decreased range of motion and muscle strength in the shoulder joint, development of pain and tenderness, and formation of lymphedema are frequently observed. In addition to causing a significant decrease in the patient's daily life quality, shoulder limitation also negatively affects the treatment process by preventing the joint position required for radiotherapy. For this reason, it is a priority to prevent the development of shoulder joint limitations that may occur following surgery and to open the developing limitation immediately. This study was born from the idea that the relaxation techniques to be applied to regain the mobility of the fascial structure, which has been damaged and whose mobility has decreased due to breast surgery, should be performed by covering the entire myofascial chain. In addition, the investigators aim to prevent adhesions that will limit the mobility of soft tissue by minimizing scar tissue formation with early drainage of postoperative edema. The aim of this study is to investigate the effectiveness of myofascial chain relaxation techniques and manual lymphatic drainage applied to improve soft tissue mobility in the prevention and elimination of shoulder limitations after breast cancer surgery.
A total of 48 patients who agreed to participate in the study will be enrolled in the treatment program twice a week for 6 weeks. During the study, the same assessments will be applied to all patients and the cases will be evaluated 3 times (pre-treatment, post treatment, and one month post treatment). During the assessments, the physical evaluations of the patients on the shoulder region will be examined in detail using objective and subjective methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: conventional physiotherapyConventional physiotherapy program (joint movement exercises, local relaxation techniques, etc.) will be applied to the participants in this group. |
| Manual lymphatic drainage group | Experimental | Other: conventional physiotherapy, Other: Manual lymphatic drainageIn addition to the conventional physiotherapy program, manual lymphatic drainage (including upper limb extremity and anterior/posterior axillar-axillar anastomoses and axilla-inguinal anastomosis) will be applied to the participants in this group. |
| Myofascial relasing group | Experimental | Other: conventional physiotherapy, Other: Myofascial relasingIn addition to the conventional physiotherapy program, myofascial chain relasing techniques will be applied to the participants in this group. |
| Lymphatic drainage and myofascial releasing group | Experimental | Other: conventional physiotherapy, Other: Manual lymphatic drainage, Other: Myofascial relasingIn addition to the conventional physiotherapy program, manual lymphatic drainage (including upper limb extremity and anterior/posterior axillar-axillar anastomoses and axilla-inguinal anastomosis) and myofascial chain relasing techniques will be applied to the participants in this group. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between the ages of 30-60
- Having breast surgery within 2 years
- Not have received conservative treatment for shoulder rehabilitation in the last 6 months
- Having limitation of movement of the shoulder joint due to breast surgery
Key exclusion criteria (13 listed)
- Not having agreed to participate in the study
- Having undergone radical mastectomy surgery
- Having connective tissue disease
- Presence of brachial plexus paresis/plegia
- Presence of radiogenic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional physiotherapyA basic physiotherapy program consisting of shoulder exercises will be applied to the participants. content of the physiotherapy program * Shoulder passive/active abduction, flexion, internal and external rotation exercises * Posture exercises * Neck stretching exercises * Pectoralis major stretching exercises * Shoulder capsule stretching exercises * Scapular Mobilization exercises | Other | Lymphatic drainage and myofascial releasing group, Manual lymphatic drainage group, Myofascial relasing group, control group |
| Manual lymphatic drainagemanual lymph drainage is a manual technique that is applied to the lymphatic system with a pressure of 40-50 mmHg and increases the working speed of lymphatic nodules/collectors. Manual lymph drainage will be made to the anterior axillar-axillar, posterior axillar-axillar and axilla-inguinal anastomosis collectors and the arm region (up to the elbow) lymph collectors. | Other | Lymphatic drainage and myofascial releasing group, Manual lymphatic drainage group |
| Myofascial relasingit will be done with the thumb or 3rd finger from the acu points of the superficial arm-anterior myofascial chain. 6-8 seconds with thumb to these points. pressure will be applied and vibration will be given clockwise. | Other | Lymphatic drainage and myofascial releasing group, Myofascial relasing group |
Primary outcome
measurement of tissue stiffness (N/m)
Time frame: changes from baseline stiffness values will be measured at 6 week and 10 week
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain .
measurement of passive muscle tone (Hz)
Time frame: changes from baseline tone values will be measured at 6 week and 10 week
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
measurement of creep of tissue
Time frame: changes from baseline creep values will be measured at 6 week and 10 week
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
measurement of the range of shoulder joint motion
Time frame: changes from baseline range of the shoulder joint motion values will be measured at 6 week and 10 week
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
assessment of activity of daily living
Time frame: changes from baseline Quick-DASH Questionnaire scores will be assessment at 6 week and 10 week
upper extremity daily living functional capacity of participation will be assessed with the Quick-DASH (Shortened Disabilities Arm, Shoulder and Hand Questionnaire). The scale consists of 11 items. In the scale, a 5-point Likert scale is evaluated and scored 1-5. The scores that can be obtained from the scale are between 0-100. Lower scores indicate better daily activity participation.
assessment of depression and anxiety
Time frame: changes from baseline HAD scale scores will be assessment at 6 week and 10 week
quality of life will be assessed using the Hospital Anxiety and Depression Scale (HAD). The scale consists of 14 items (7 items depression and 7 items anxiety). The scale is evaluated on a 4-point Likert scale and is scored 0-3. Depression and anxiety scores are calculated separately. While the score range that can be taken in the lower scales is 0-21, low scores are considered positive.
4 secondary outcomes
measurement of skin temperature
Time frame: changes from baseline skin temperature values will be measured at 6 week and 10 week
measurement of pain
Time frame: changes from baseline pain values will be measured at 6 week and 10 week
measurement of pain pressure threshold
Time frame: changes from baseline pain pressure threshold values will be measured at 6 week and 10 week
measurement of grip strength
Time frame: changes from baseline grip strength values will be measured at 6 week and 10 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Survivors
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruitingPhase 2
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors
Breast Cancer, Hyposexual Desire Disorder
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physiotherapy, Manual lymphatic drainage and Myofascial relasing in people with Breast Cancer Survivors, run by Istanbul Medeniyet University 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 4 inclusion and 13 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 3 Aug 2026. 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?
measurement of tissue stiffness (N/m) (time frame: changes from baseline stiffness values will be measured at 6 week and 10 week). The study lists 6 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 3 Aug 2026.