Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Females | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultrasound guided dextrose prolotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Participants in this single experimental arm will receive three sessions of ultrasound-guided dextrose injections (e.g., 5% or 15% Dextrose) targeting symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axilla, such as the pectoralis major-minor interface or axillary fascia. Injections are administered at 4-week intervals (at Baseline, Week 4, and Week 8). Throughout the 6-month study period, all participants continue their standardized rehabilitation program, which includes range-of-motion exercises, stretching of the chest wall and axillary musculature, and progressive strengthening.
- interventionNames
- Procedure: ultrasound guided dextrose prolotherapy
Primary outcomes (1)
- measure
- Upper Extremity Function
- timeFrame
- Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection
- description
- Upper extremity functional limitation was assessed using the QuickDASH questionnaire, with scores ranging from 0 (no disability) to 100 (most severe disability). The minimal clinically important difference (MCID) for the QuickDASH was defined as 15 points
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available