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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05911867
Other study ID # F.P.T2207005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date September 30, 2023

Study information

Verified date June 2023
Source Cairo University
Contact Hany M Elgohary, Ph.D
Phone 00201093182291
Email hmielgohary@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date September 30, 2023
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
combination of mobilization with movement and muscle energy techniques
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.
muscle energy techniques Interventions:
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.
mobilization with movement
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.

Locations

Country Name City State
Egypt Hany Mohamed Elgohary Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Quick DASH scale 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. 6 weeks
Primary 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 6 weeks
Secondary 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 6 weeks
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