NCT07697495

Brief Summary

This single-center randomized controlled trial aims to investigate the effects of adding scapulothoracic stabilization and postural training to standard lymphedema care in women with secondary upper extremity lymphedema following breast cancer surgery. Participants will be randomly assigned to receive either standard lymphedema care alone or standard care combined with scapulothoracic stabilization and postural training. Outcomes including scapular muscle strength, posture, upper extremity function, limb volume, and neck awareness will be assessed at baseline, immediately after treatment, and at a 2-month follow-up. The findings are expected to provide evidence regarding the effectiveness of incorporating targeted stabilization and postural exercises into conventional lymphedema rehabilitation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 6, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Upper Extremity LymphedemaScapulothoracic StabilizationPostural TrainingMuscle StrengthPosture

Outcome Measures

Primary Outcomes (4)

  • Change in Upper Extremity Function

    Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The DASH is a validated 30-item patient-reported outcome measure evaluating symptoms and functional limitations of the upper extremity. Scores range from 0 to 100, with higher scores indicating greater disability.

    Baseline, immediately after completion of treatment, and 2 months after treatment

  • Change in Head Anterior Translation

    Head anterior translation will be assessed using the PostureScreen mobile application.

    Baseline, immediately after completion of treatment, and 2 months after treatment

  • Change in Shoulder Height Asymmetry

    Shoulder height asymmetry will be assessed using the PostureScreen mobile application.

    Baseline, immediately after completion of treatment, and 2 months after treatment.

  • Change in Shoulder Anterior Translation

    Shoulder anterior translation will be assessed using the PostureScreen mobile application.

    Baseline, immediately after completion of treatment, and 2 months after treatment.

Secondary Outcomes (1)

  • Change in Scapular Muscle Strength

    Baseline, immediately after completion of treatment, and 2 months after treatment

Study Arms (2)

Scapulothoracic Stabilization

EXPERIMENTAL

Participants assigned to the experimental group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with a structured scapulothoracic stabilization and postural training program. The additional exercise program is designed to improve scapular muscle function, postural alignment, and upper extremity function. Assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.

Procedure: Complex Decongestive TherapyBehavioral: Scapulothoracic Stabilization and Postural Training

Control

ACTIVE COMPARATOR

Participants assigned to the control group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises according to routine clinical practice. Outcome assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.

Procedure: Complex Decongestive Therapy

Interventions

Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises. Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.

ControlScapulothoracic Stabilization

A supervised exercise program consisting of scapulothoracic stabilization exercises and postural training designed to improve scapular muscle strength, postural alignment, and upper extremity function. The program will be provided in addition to standard Complex Decongestive Therapy throughout the treatment period.

Scapulothoracic Stabilization

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged 18 to 65 years.
  • Diagnosed with secondary upper extremity lymphedema following breast cancer surgery (mastectomy).
  • Willing to participate in the study.
  • Able to provide written informed consent.

You may not qualify if:

  • Active infection (e.g., cellulitis or lymphangitis).
  • Advanced shoulder or cervical pathology.
  • Neurological disorders affecting upper extremity function.
  • Metastatic disease.
  • Receiving active chemotherapy.
  • Participation in another intensive lymphedema rehabilitation program within the previous 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Turkey (Türkiye)

RECRUITING

Central Study Contacts

İdil Esin Ünlü, Assist. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded. However, all outcome assessments will be performed by an independent assessor who is blinded to treatment allocation. Participants will be instructed not to disclose their group assignment during assessments, and statistical analyses will be conducted using coded group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The control group will receive standard Complex Decongestive Therapy (CDT), while the intervention group will receive standard CDT combined with scapulothoracic stabilization and postural training. Outcome assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 13, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations