NCT07297706

Brief Summary

The purpose of this study is to compare the therapeutic effects of pilates exercises and mirror therapy on shoulder dysfunction post-neck dissection surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of pain intensity

    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 Outcomes (4)

  • assessment of shoulder flexion range of motion

    at baseline and after 8 weeks

  • Assessment of shoulder external rotation range of motion

    at baseline and after 8 weeks

  • Assessment of the shoulder abduction range of motion

    at baseline and after 8 weeks

  • assessment of upper limb function

    at baseline and after 8 weeks

Study Arms (2)

Pilates exercises

EXPERIMENTAL

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 exercisesOther: Traditional physical therapy

Mirror therapy

ACTIVE COMPARATOR

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: Mirror therapyOther: Traditional physical therapy

Interventions

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.

Pilates exercises

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

Mirror therapy

including (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)

Mirror therapyPilates exercises

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainy Learning Hospital and National Cancer Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Exercise Movement TechniquesMirror Movement Therapy

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

April 1, 2025

Primary Completion

September 13, 2025

Study Completion

October 13, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations