Dextrose Hydrodissection for Post-Breast Cancer Chest Wall and Axillary Tightness.
Recruiting · NCT07378319 · Interventional (participants receive a specific treatment) · Lead sponsor: Taichung Veterans General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- History of breast cancer surgery (mastectomy or breast-conserving surgery), with or without axillary lymph node dissection
- Persistent ipsilateral chest wall and/or axillary pain, tightness, or movement restriction lasting ≥ 3 months after surgery;
- Clinically significant baseline symptom severity, defined as Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire ≥ 25 and/or pain intensity ≥ 5/10 on the Numeric Rating Scale (NRS);
- Completion of 12 weeks of standard physical therapy with no significant improvement, defined as a change in QuickDASH score from baseline to completion of therapy below the minimal clinically important difference (MCID; \<15 points ) and/or pain improvement \< 2 points on the NRS .
- Age ≥ 18 years;
- Ability to provide written informed consent.
Exclusion criteria
- Evidence of local cancer recurrence or metastatic disease;
- Active lymphedema requiring ongoing decongestive therapy at the time of enrollment;
- Shoulder pathology, including intra-articular or peri-articular conditions (e.g., adhesive capsulitis with marked capsular restriction, or acute rotator cuff tear,) judged by clinical assessment to be the dominant cause of symptoms.
- Active infection, skin lesion, or unhealed surgical wound at the intended injection site;
- Known bleeding disorders or anticoagulant use contraindicating injection;
- Known allergy to dextrose or any components of the injection protocol;
- Pregnancy or other medical conditions precluding participation.
Where it is running
1 location listed.
- Taichung Veterans Genetal Hospital - Taichung, Taiwan, Taiwan