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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTaichung Veterans General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • ultrasound guided dextrose prolotherapy

    Procedure/Surgery

    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).

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Upper Extremity Function

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

Secondary outcomes

1

Pain Intensity

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
2

Shoulder Range of Motion

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
3

Pectoralis Minor Length

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
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

Other outcomes

1

Patient Global Impression of Change

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.

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

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