NCT05911867

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 11, 2023

Last Update Submit

June 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Postural Assessment Software (PAS/SAPO)

    6 weeks

Other Outcomes (1)

  • Quick DASH scale

    6 weeks

Study Arms (3)

combination of mobilization with movement and muscle energy techniques

EXPERIMENTAL

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.

Other: combination of mobilization with movement and muscle energy techniques

mobilization with movement

ACTIVE COMPARATOR

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.

Other: mobilization with movement

muscle energy techniques

ACTIVE COMPARATOR

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.

Other: muscle energy techniques Interventions:

Interventions

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.

Also known as: MWM
combination of mobilization with movement and muscle energy techniques

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.

Also known as: MET
muscle energy techniques

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.

mobilization with movement

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • between 50 and 65 years
  • limited shoulder range of motion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hany Mohamed Elgohary

Cairo, 11432, Egypt

RECRUITING

Related 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.

    PMID: 30613078BACKGROUND

MeSH Terms

Conditions

Mobility LimitationBreast Neoplasms

Interventions

Movement

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hany M Elgohary

    Delta University for Science and Technology, Gamasa, Coastal Road

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
both participants and outcome assessors are blind for groups allocation and treatment modalities
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: controlled, single-blinded, and randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

June 11, 2023

First Posted

June 22, 2023

Study Start

June 1, 2023

Primary Completion

September 15, 2023

Study Completion

September 30, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

i have no intent to share results

Locations