Taichung Veterans Genetal Hospital
Taichung, Taiwan, 407
Location status: Recruiting
NCT Number: NCT07378319
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Taichung, Taiwan, 407
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants 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).
Time frame: 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
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
Time frame: 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
Pain intensity was measured using the Numeric Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Participants were instructed to rate their pain intensity during provoked overhead activity or movements that most reliably reproduced their symptoms. A change of ≥ 2 points on the NRS was considered clinically meaningful
Time frame: 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
Active shoulder range of motion (AROM) was measured using a standard goniometer, including forward flexion and abduction, the most consistently assessed directions across prior studies
Time frame: 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
Anterior chest wall soft-tissue tightness was assessed by measuring pectoralis minor muscle length. Specifically, the linear distance between the coracoid process and the anterior inferior edge of the fourth rib was measured in the supine position
Time frame: 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
Overall perceived improvement was evaluated using the Patient Global Impression of Change (PGIC) scale. Participants rated their overall change in symptoms since the intervention on a 7-point Likert scale, ranging from 1 (very much worse) to 7 (very much improved). Scores ≧ 5 (minimal improvement) were considered clinically relevant global improvement.
Contact information is provided by the study sponsor or research team.
Taichung Veterans General Hospital
Other
Effectiveness of Ultrasound-Guided Dextrose Prolotherapy for Persistent Chest Wall and Axillary Symptoms in Breast Cancer Survivors: A Prospective Case Series.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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