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RecruitingNCT07378319

Dextrose Hydrodissection for Post-Breast Cancer Chest Wall and Axillary Tightness.

Effectiveness of Ultrasound-Guided Dextrose Prolotherapy for Persistent Chest Wall and Axillary Symptoms in Breast Cancer Survivors: A Prospective Case Series.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Taichung Veterans General Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial (prospective case series) is to evaluate the feasibility, safety, and preliminary clinical outcomes of ultrasound-guided dextrose prolotherapy in female breast cancer survivors with persistent ipsilateral chest wall and axillary pain and tightness who have plateaued with standard physical therapy. The main questions it aims to answer are: Does ultrasound-guided dextrose prolotherapy significantly improve upper extremity functional limitation (measured by the QuickDASH questionnaire)? What are the effects of this intervention on pain intensity (NRS), active shoulder range of motion (AROM), and anterior chest wall soft-tissue tightness (pectoralis minor muscle length)? Participants will: Undergo a comprehensive baseline physical examination and ultrasound assessment of the symptomatic chest wall and axilla. Receive three sessions of ultrasound-guided 5% dextrose injections into targeted soft-tissue planes at 4-week intervals. Continue their designated standard rehabilitation program, including range-of-motion and stretching exercises. Attend follow-up assessments at 4-week intervals during the treatment phase, with long-term follow-up at 3 and 6 months after the final injection to evaluate the durability of the response.

Detailed description

Detailed Description Post-surgical breast cancer survivors often experience persistent shoulder and upper-quarter dysfunction characterized by chest wall and axillary tightness. While conventional physical therapy focuses on joint mobilization and stretching, a subset of patients with significant soft-tissue fibrosis and scar adhesions-patterns reflecting extra-articular restriction-remains non-responsive to standard care. This prospective case series evaluates the role of ultrasound-guided dextrose prolotherapy as a targeted intervention for this challenging clinical problem. The rationale is based on the mechanical and biological effects of dextrose-based hydrodissection, which aims to separate adherent fascial planes and promote tissue remodeling in areas of postoperative myofascial restriction. Procedural Workflow: Scanning Protocol: A high-frequency linear transducer is used to systematically scan the ipsilateral pectoral and axillary regions. The physician identifies symptomatic areas characterized by tissue thickening, loss of normal fascial glide, or focal tenderness. Injection Technique: Using a sterile, ultrasound-guided approach, a dextrose solution is administered into the identified myofascial or perimysial planes. The injection targets are individualized based on each participant's specific site of restriction (e.g., between the pectoralis major and minor muscles or within the axillary fascia). Frequency and Duration: Participants receive a total of three injection sessions spaced 4 weeks apart. This interval allows for the observation of cumulative clinical effects and soft-tissue adaptation. Integrated Care: To maximize functional gains, all participants continue a standardized, home-based rehabilitation program consisting of progressive stretching and postural correction throughout the 6-month study period. The study aims to provide preliminary data on whether this interventional approach can bridge the therapeutic gap for survivors with persistent myofascial symptoms despite prior rehabilitation.

Conditions

Interventions

TypeNameDescription
PROCEDUREultrasound guided dextrose prolotherapyParticipants receive three sessions of ultrasound-guided 5% dextrose injections into symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axillary region. The technique involves identifying areas of soft-tissue thickening or restricted fascial glide under high-frequency ultrasound. Injection targets are individualized to each patient's specific site of restriction (e.g., clavipectoral fascia, pectoralis major-minor interface, or axillary fascia). Sessions are administered at 4-week intervals (at weeks 0, 4, and 8).

Timeline

Start date
2025-01-11
Primary completion
2026-02-01
Completion
2026-06-28
First posted
2026-01-30
Last updated
2026-03-20

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT07378319. Inclusion in this directory is not an endorsement.