NCT06555913

Brief Summary

Sixty patients from both genders suffering from shoulder disability post unilateral NDS (modified radical, selective) will participate in this study. Their ages will be ranged from 30 to 50 years. They will be selected randomly from Damanhur Oncology center, El-Behira, Egypt. They will be randomly distributed into three equal groups (each group 20 patients).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 13, 2024

Last Update Submit

August 18, 2024

Conditions

Keywords

Maitland MobilizationScapular StabilizationShoulder DysfunctionNeck Dissection Surgeries

Outcome Measures

Primary Outcomes (1)

  • Digital Goniometer

    Digital goniometer is a device which measures joint ranges, together with velocity and acceleration variables, with a high level of precision and at a relatively low-cost, practically similar to current analogical tools. The digital goniometer is a device specifically designed for the measurement of angles of movement of the human body with a resolution of 1°, representing an ideal substitute to traditional goniometers, which are usually based on a scale of 5° increments

    2 months

Secondary Outcomes (1)

  • Shoulder Pain and Disability Index

    2 months

Study Arms (3)

Maitland Mobilization and Scapular Stabilization

EXPERIMENTAL

This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique and scapular stabilization exercises in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.

Other: Maitland MobilizationOther: Scapular StabilizationOther: Traditional Physical Therapy

Maitland Mobilization

EXPERIMENTAL

This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.

Other: Maitland MobilizationOther: Traditional Physical Therapy

Scapular Stabilization

EXPERIMENTAL

This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received scapular stabilization exercises in addition to the traditional physical therapy program which include (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.

Other: Scapular StabilizationOther: Traditional Physical Therapy

Interventions

MM applies a passive oscillatory technique, classified from Grade I-IV with respect to intensity, to the shoulder in order to treat pain and stiffness. Grade I refers to an intensity of small amplitude that is applied at the beginning of the joint ROM, where there is no loading on connective tissue; it is often used in cases of severe pain

Maitland MobilizationMaitland Mobilization and Scapular Stabilization

Scapular stabilization exercises are thought to have an important role in improving pain and dysfunction in the shoulder. The concept that an unstable scapula is associated with pathology and dysfunction of the shoulder is well accepted. The predominant theory emphasizes that for optimal function of the glenohumeral joint, the scapula must provide a stable base upon which upper extremity tasks are completed. Impaired scapular stability increases the risk for pathologies such as impingement or rotator cuff tears

Maitland Mobilization and Scapular StabilizationScapular Stabilization

ROM exercises, stretching exercises and strengthening exercises for shoulder muscles

Maitland MobilizationMaitland Mobilization and Scapular StabilizationScapular Stabilization

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients' age will be ranged between 30-50 years.
  • Both genders will participate in this study.
  • All patients suffering from shoulder pain and disability following unilateral modified radical NDS or selective NDS.
  • All patients will begin the treatment program from 1 to 3 months after NDS.
  • All patients will have limited ROM of shoulder flexion, abduction, external rotation.
  • All patients enrolled to the study will have their informed consent.

You may not qualify if:

  • Subjects with rotator cuff tears or other •shoulder ligament injuries.
  • Adhesive capsulitis secondary to Diabetes mellitus or fractures.
  • Recurrent shoulder dislocation.
  • Recent fracture or surgery to the shoulder.
  • Reflex sympathetic dystrophy.
  • Neurological disorder.
  • Epilepsy or any psychological disorders.
  • The presence of residual local-regional cancer or distant metastases to other regions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Research Ethical Committee Faculty of Physical Therapy

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Physical Therapy - Hosh Essa Hospital - El-Behira.

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 15, 2024

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations