Pilates Exercises Versus Mirror Therapy on Shoulder Dysfunction Post Neck Dissection Surgeries

December 9, 2025 updated by: Yasmen gamal Elrakhawi, Cairo University
The purpose of this study is to compare the therapeutic effects of pilates exercises and mirror therapy on shoulder dysfunction post-neck dissection surgeries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Shoulder morbidity is a significant concern for patients undergoing neck dissection in head and neck cancer treatment, with more extensive surgeries correlated with higher postoperative shoulder issues. Preservation of the spinal accessory nerve during modified radical neck dissection reduces shoulder dysfunction. Shoulder pain often results from trapezius deficits due to nerve injury, leading to symptoms like shoulder droop and loss of function. Current management of oral and oropharyngeal carcinoma focuses on selective procedures that maintain nonlymphatic structures in the neck, as extended dissections are linked to increased shoulder dysfunction. This study aims to compare the effectiveness of pilates exercises and mirror therapy in improving shoulder dysfunction after neck dissection surgeries.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr El Ainy Learning Hospital and National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient's age ranged between 35-55 years.
  2. Both genders will participate in the study.
  3. All patients suffering from shoulder dysfunction post-unilateral neck dissection surgeries ( modified radical and selective neck dissection surgeries).
  4. All patients will have shoulder pain, limited ROM (flexion, abduction, external rotation) and limited shoulder function.
  5. All patients will begin the treatment program 1-3 months after neck dissection surgeries.
  6. All patients enrolled in the study will have their informed consent.

Exclusion Criteria:

  1. Subjects suffering from active malignant tumors.
  2. Subjects with rotator cuff tears or other shoulder ligaments injuries.
  3. A history of neck or ipsilateral shoulder injuries, pain in the last 6-month prior neck dissection surgeries.
  4. Adhesive capsulitis secondary to diabetes mellitus or fractures.
  5. Recurrent shoulder dislocation.
  6. Recent fractures or surgeries in the shoulder.
  7. Neurological disorder
  8. The presence of residual local regional cancer or distant metastases to other regions.
  9. Comorbid medical illness or psychiatric illness and visual disturbance that would prevent completion of treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates exercises
This group will include 26 patients suffering from shoulder post-neck dissection surgeries (Modified radical and selective NDS). They will receive the pilate exercises for 40 min/session, 3 sessions/ week for 8 weeks, in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)
Other: Pilates exercises
Pilates exercise aids in recovery post-breast cancer surgery by improving daily living activities, shoulder function, and quality of life. It emphasizes principles such as centralization, concentration, control, precision, flow, and breathing, enhancing muscle strength and flexibility. Additionally, mild stretching exercises contribute to maintaining and increasing range of motion, and Pilates can be tailored to individual patient needs and abilities.
Other: Traditional physical therapy
including (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)
Active Comparator: Mirror therapy
This group will include 26 patients suffering from shoulder dysfunction post neck dissection surgeries (modified radical, and selective NDS), they will receive Mirror therapy for 40 min/session, 3 sessions/ week for 8 weeks in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)
Other: Traditional physical therapy
including (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)
Other: Mirror therapy
Mirror therapy has been shown to enhance shoulder function in patients with shoulder problems immediately after the intervention. Three-minute of Mirror therapy improved forward flexion by 14.5° in patients with shoulder pain and limited shoulder range of motion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assessment of pain intensity
Time Frame: at baseline and after 8 weeks
Participants in both groups will mark a number on a 10-cm line (0 to 10) to indicate their pain level, with 10 being the most painful. Pain ratings during exercise was assessed at baseline (pre-treatment) and after 8 weeks of treatment (post-treatment) using visual analogue numeric pain scale
at baseline and after 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assessment of shoulder flexion range of motion
Time Frame: at baseline and after 8 weeks
Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. For shoulder flexion, the goniometer's axis will be placed over the acromion process, the stationary arm aligned with the midaxillary line, and the moving arm positioned along the central line of the upper arm.
at baseline and after 8 weeks
Assessment of shoulder external rotation range of motion
Time Frame: at baseline and after 8 weeks
Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. External rotation is assessed when the upper limb is in a 90° abducted position. The goniometer's axis is positioned at the olecranon process, the stationary arm is aligned parallel to the ground, and the moving arm is adjusted to the ulna.
at baseline and after 8 weeks
Assessment of the shoulder abduction range of motion
Time Frame: at baseline and after 8 weeks
Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. Shoulder abduction measurement involves positioning the goniometer's axis over the acromion process, aligning the stationary arm parallel to the spine, and setting the moving arm along the central line of the upper arm, following the protocol recommended by Lee and Kim
at baseline and after 8 weeks
assessment of upper limb function
Time Frame: at baseline and after 8 weeks
The study assessed upper limb function using the Arabic version of the Quick Disabilities of the Arm, Shoulder and Hand-9 scale before and after 8 weeks of treatment. The scale consists of 9 items rated on a 4-point Likert scale, where higher scores indicate increased disability and reduced function. A scaled score is computed from the total scores (0-100) using a specific formula, accommodating missing items by averaging remaining scores. Progress was measured by calculating the percent improvement in Quick Disabilities of the Arm, Shoulder and Hand-9 scores post-treatment.
at baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Yasmen-Msc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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