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Muscle Energy Technique and Mulligan's Mobilization in Breast Cancer Surgery Patients (MWMMET)

Primary Purpose

Mobility Limitation, Muscle Relaxation, Kinematics

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
combination of mobilization with movement and muscle energy techniques
muscle energy techniques Interventions:
mobilization with movement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mobility Limitation

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: female between 50 and 65 years limited shoulder range of motion Exclusion Criteria: having metastases lymphedema traumatic or musculoskeletal disorders affecting the arm not taking anticoagulants not having undergone bilateral breast cancer surgery not having a locoregional recurrence not having vascular disorders in the affected arm

Sites / Locations

  • Hany Mohamed ElgoharyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

combination of mobilization with movement and muscle energy techniques

mobilization with movement

muscle energy techniques

Arm Description

Mulligan technique (MWM) involves the therapist using a belt around the humeral head to guide appropriate gliding while the patient moves their shoulder actively through the range. The therapist applies pressure to the scapula in a counter direction. Regarding the cervical spine, the second technique, Cervical Self-Natural Apophyseal Glides (SNAG), involves the therapist standing behind the patient and applying force to the spinous process of each vertebra using a thumb-over-thumb technique. The examiner passively abducts the arm in the horizontal plane until the first barrier to motion by applying pressure to the distal humerus. This passive stretch will be held for three seconds.

Regarding the shoulder joint, the Mulligan technique (MWM) involves the therapist using a belt around the humeral head to guide appropriate gliding while the patient moves their shoulder actively through the range. The therapist applies pressure to the scapula in a counter direction. This technique is usually performed for five sets of five repetitions with one minute of rest between sets in a sitting position. Regarding the cervical spine, the second technique, Cervical Self-Natural Apophyseal Glides (SNAG), involves the therapist standing behind the patient and applying force to the spinous process of each vertebra using a thumb-over-thumb technique. The patient actively performs repeated flexion or extension of their neck, returning back to the neutral position.

The examiner passively abduct the arm in the horizontal plane until the first barrier to motion by applying pressure to the distal humerus. This passive stretch will be held for three seconds. The examiner then instruct the participant to attempt to horizontally adduct the test arm at 25% of their maximal effort while the examiner applies manual resistance at the distal humerus to create an isometric contraction lasting five seconds. The participant then actively abduct the arm in the horizontal plane for a three-second active-assisted stretch.

Outcomes

Primary Outcome Measures

digital inclinometer
). This tool is recognized as valid and reliable for this purpose and requires the patient to move their affected shoulder in various directions while keeping their feet fixed in place

Secondary Outcome Measures

Postural Assessment Software (PAS/SAPO)
The women participants were positioned in a comfortable stance, and anatomical markers will be attached to specific points such as the tragus and both acromions. Their photographs will be captured and later analyzed using the PAS/SAPO software to record the cervical angle and horizontal alignment of the acromions. A forward head position was identified by an angle less than 50°. This method has been demonstrated to be reliable and valid for identifying forward head positions

Full Information

First Posted
June 11, 2023
Last Updated
June 20, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05911867
Brief Title
Muscle Energy Technique and Mulligan's Mobilization in Breast Cancer Surgery Patients
Acronym
MWMMET
Official Title
The Combined Effect of Mulligan and Muscle Energy Techniques on Shoulder Kinematics and Postural Changes After Breast Cancer Surgery With Axillary Dissection: A Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
A recent study aimed to examine the combined effect of Mulligan and muscle energy techniques on postural changes and shoulder kinematics among women who had undergone breast cancer surgery with axillary dissection.
Detailed Description
90 female patients who had undergone breast cancer surgery with axillary dissection were recruited and randomly assigned to three groups. Group A received Mulligan and muscle energy technique, group B received Mulligan technique only, and group C received muscle energy technique. The study measured shoulder kinematics and postural changes using a digital inclinometer for range of motion, PAS/SAPO for cervical angle, and the horizontal alignment of acromions and quick DASH for upper extremity activities. Outcome measurements were taken at three different time points: baseline, six weeks post-intervention, and eight weeks after the intervention during a follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Muscle Relaxation, Kinematics, Postural; Defect, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
controlled, single-blinded, and randomized clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
both participants and outcome assessors are blind for groups allocation and treatment modalities
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination of mobilization with movement and muscle energy techniques
Arm Type
Experimental
Arm Description
Mulligan technique (MWM) involves the therapist using a belt around the humeral head to guide appropriate gliding while the patient moves their shoulder actively through the range. The therapist applies pressure to the scapula in a counter direction. Regarding the cervical spine, the second technique, Cervical Self-Natural Apophyseal Glides (SNAG), involves the therapist standing behind the patient and applying force to the spinous process of each vertebra using a thumb-over-thumb technique. The examiner passively abducts the arm in the horizontal plane until the first barrier to motion by applying pressure to the distal humerus. This passive stretch will be held for three seconds.
Arm Title
mobilization with movement
Arm Type
Active Comparator
Arm Description
Regarding the shoulder joint, the Mulligan technique (MWM) involves the therapist using a belt around the humeral head to guide appropriate gliding while the patient moves their shoulder actively through the range. The therapist applies pressure to the scapula in a counter direction. This technique is usually performed for five sets of five repetitions with one minute of rest between sets in a sitting position. Regarding the cervical spine, the second technique, Cervical Self-Natural Apophyseal Glides (SNAG), involves the therapist standing behind the patient and applying force to the spinous process of each vertebra using a thumb-over-thumb technique. The patient actively performs repeated flexion or extension of their neck, returning back to the neutral position.
Arm Title
muscle energy techniques
Arm Type
Active Comparator
Arm Description
The examiner passively abduct the arm in the horizontal plane until the first barrier to motion by applying pressure to the distal humerus. This passive stretch will be held for three seconds. The examiner then instruct the participant to attempt to horizontally adduct the test arm at 25% of their maximal effort while the examiner applies manual resistance at the distal humerus to create an isometric contraction lasting five seconds. The participant then actively abduct the arm in the horizontal plane for a three-second active-assisted stretch.
Intervention Type
Other
Intervention Name(s)
combination of mobilization with movement and muscle energy techniques
Other Intervention Name(s)
MWM
Intervention Description
The examiner passively abducts the arm in the horizontal plane until the first barrier to motion by applying pressure to the distal humerus. The participant then actively abduct the arm in the horizontal plane for a three-second active-assisted stretch. Regarding the cervical spine, the second technique, Cervical Self-Natural Apophyseal Glides (SNAG), involves the therapist standing behind the patient and applying force to the spinous process of each vertebra using a thumb-over-thumb technique. The patient actively performs repeated flexion or extension of their neck, returning back to the neutral position. The passive gliding is maintained in the anterosuperior direction along the facet joint line while flexing or extending the neck throughout the range.
Intervention Type
Other
Intervention Name(s)
muscle energy techniques Interventions:
Other Intervention Name(s)
MET
Intervention Description
The examiner passively abduct the arm in the horizontal plane until the first barrier to motion by applying pressure to the distal humerus. This passive stretch will be held for three seconds. The examiner then instruct the participant to attempt to horizontally adduct the test arm at 25% of their maximal effort while the examiner applied manual resistance at the distal humerus to create an isometric contraction lasting five seconds. The participant then actively abduct the arm in the horizontal plane for a three-second active-assisted stretch.
Intervention Type
Other
Intervention Name(s)
mobilization with movement
Intervention Description
Regarding the cervical spine, the second technique, Cervical Self-Natural Apophyseal Glides (SNAG), involves the therapist standing behind the patient and applying force to the spinous process of each vertebra using a thumb-over-thumb technique. The patient actively performs repeated flexion or extension of their neck, returning back to the neutral position. The passive gliding is maintained in the anterosuperior direction along the facet joint line while flexing or extending the neck throughout the range.
Primary Outcome Measure Information:
Title
digital inclinometer
Description
). This tool is recognized as valid and reliable for this purpose and requires the patient to move their affected shoulder in various directions while keeping their feet fixed in place
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Postural Assessment Software (PAS/SAPO)
Description
The women participants were positioned in a comfortable stance, and anatomical markers will be attached to specific points such as the tragus and both acromions. Their photographs will be captured and later analyzed using the PAS/SAPO software to record the cervical angle and horizontal alignment of the acromions. A forward head position was identified by an angle less than 50°. This method has been demonstrated to be reliable and valid for identifying forward head positions
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Quick DASH scale
Description
The Arabic version of the Quick-DASH questionnaire includes 11 items, which inquire about the patient's difficulty in performing physical activities related to the upper extremity, the severity of pain and tingling, and the impact of the problem on social activities, work, and sleep. Each item includes five response options, ranging from no difficulty to being unable to perform the activity. If at least 10 items are answered, their responses are added to create a raw score, which is then transformed to a 0-100 scale.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female between 50 and 65 years limited shoulder range of motion Exclusion Criteria: having metastases lymphedema traumatic or musculoskeletal disorders affecting the arm not taking anticoagulants not having undergone bilateral breast cancer surgery not having a locoregional recurrence not having vascular disorders in the affected arm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany M Elgohary, Ph.D
Phone
00201093182291
Email
hmielgohary@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa M Khedr
Phone
00201555001550
Email
alaa.wageeh25@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany M Elgohary
Organizational Affiliation
Delta University for Science and Technology, Gamasa, Coastal Road
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hany Mohamed Elgohary
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M Elgohary, PhD
Phone
0590997821
Email
gohary75pt@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
i have no intent to share results
Citations:
PubMed Identifier
30613078
Citation
Elgohary HM, Eladl HM, Soliman AH, Soliman ES. Effects of Ultrasound, Laser and Exercises on Temporomandibular Joint Pain and Trismus Following Head and Neck Cancer. Ann Rehabil Med. 2018 Dec;42(6):846-853. doi: 10.5535/arm.2018.42.6.846. Epub 2018 Dec 28.
Results Reference
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Muscle Energy Technique and Mulligan's Mobilization in Breast Cancer Surgery Patients

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