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The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors

Primary Purpose

Breast Cancer Survivors

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
conventional physiotherapy
Manual lymphatic drainage
Myofascial relasing
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Survivors focused on measuring breast cancer, range of motion, lymphatic drainage

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.)

Sites / Locations

  • İstanbul Medeniyet University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

control group

Manual lymphatic drainage group

Myofascial relasing group

Lymphatic drainage and myofascial releasing group

Arm Description

Conventional physiotherapy program (joint movement exercises, local relaxation techniques, etc.) will be applied to the participants in this group.

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.

In addition to the conventional physiotherapy program, myofascial chain relasing techniques will be applied to the participants in this group.

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.

Outcomes

Primary Outcome Measures

measurement of tissue stiffness (N/m)
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain .
measurement of passive muscle tone (Hz)
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
measurement of creep of tissue
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
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
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
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.

Secondary Outcome Measures

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).
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.
measurement of pain pressure threshold
Pain pressure threshold will be evaluated by a digital algometer (Algometer Commander, Jtech Medical, MM036_K, 2016).
measurement of grip strength
The grip strength of both hand will be evaluated by "hand-held" dynamometer.

Full Information

First Posted
May 18, 2022
Last Updated
May 25, 2022
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05386628
Brief Title
The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors
Official Title
The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion Following Mastectomy Surgery in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors
Keywords
breast cancer, range of motion, lymphatic drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy program (joint movement exercises, local relaxation techniques, etc.) will be applied to the participants in this group.
Arm Title
Manual lymphatic drainage group
Arm Type
Experimental
Arm Description
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.
Arm Title
Myofascial relasing group
Arm Type
Experimental
Arm Description
In addition to the conventional physiotherapy program, myofascial chain relasing techniques will be applied to the participants in this group.
Arm Title
Lymphatic drainage and myofascial releasing group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Manual lymphatic drainage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial relasing
Intervention Description
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.
Primary Outcome Measure Information:
Title
measurement of tissue stiffness (N/m)
Description
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain .
Time Frame
changes from baseline stiffness values will be measured at 6 week and 10 week
Title
measurement of passive muscle tone (Hz)
Description
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
Time Frame
changes from baseline tone values will be measured at 6 week and 10 week
Title
measurement of creep of tissue
Description
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
Time Frame
changes from baseline creep values will be measured at 6 week and 10 week
Title
measurement of the range of shoulder joint motion
Description
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
Time Frame
changes from baseline range of the shoulder joint motion values will be measured at 6 week and 10 week
Title
assessment of activity of daily living
Description
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.
Time Frame
changes from baseline Quick-DASH Questionnaire scores will be assessment at 6 week and 10 week
Title
assessment of depression and anxiety
Description
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.
Time Frame
changes from baseline HAD scale scores will be assessment at 6 week and 10 week
Secondary Outcome Measure Information:
Title
measurement of skin temperature
Description
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).
Time Frame
changes from baseline skin temperature values will be measured at 6 week and 10 week
Title
measurement of pain
Description
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.
Time Frame
changes from baseline pain values will be measured at 6 week and 10 week
Title
measurement of pain pressure threshold
Description
Pain pressure threshold will be evaluated by a digital algometer (Algometer Commander, Jtech Medical, MM036_K, 2016).
Time Frame
changes from baseline pain pressure threshold values will be measured at 6 week and 10 week
Title
measurement of grip strength
Description
The grip strength of both hand will be evaluated by "hand-held" dynamometer.
Time Frame
changes from baseline grip strength values will be measured at 6 week and 10 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
breast cancer survivors
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nilüfer Kablan, PhD
Phone
+905067638556
Email
niluferkablan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gülser Cinbaz, MSc
Phone
+905558503576
Email
gulser.cinbaz@gmail.com
Facility Information:
Facility Name
İstanbul Medeniyet University
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülser Cinbaz
Phone
+905558502576
Email
gulser.cinbaz@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
26079868
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
16225693
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
12924842
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
31864435
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
22018755
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
18192154
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
25977305
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/
Available IPD/Information Identifier
20068255

Learn more about this trial

The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors

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