5. Current systemic inflammatory disease with active systemic therapy likely to change local inflammation
rapidly (e.g., newly started/changed dose within prior 3 months of systemic corticosteroids, biologic DMARDs).
Consider excluding patients on high-dose systemic steroids (>10 mg prednisone equivalent/day).
Rationale: systemic treatments confound local imaging response.
6. Local corticosteroid injection at the target site within the prior 3 months (or other local biologic injection
such
as
PRP
within
6
months),
or
scheduled
injection
during
study
period.
Rationale: injections have large effects on ultrasound and symptoms.
7. Planned surgery at the target site during the follow-up period or significant structural lesion incompatible
with conservative therapy (e.g., full-thickness tendon rupture requiring surgery).
Rationale: prevents mixing surgical outcomes with therapy effects.
8. Severe peripheral neuropathy or sensory loss at the treatment area (e.g., advanced diabetic neuropathy) if it
impairs the ability to sense stimulation or increases the risk of burns. Use of anticoagulation or bleeding diathesis
that, in the investigator’s judgment, makes repeated electrode placement unsafe, or active skin bleeding disorders
at the site. (This can be site-specific; many trials allow stable anticoagulation.)
9. Concurrent participation in another interventional clinical trial for the same condition. Inability to comply
with follow-up or provide consent (e.g., cognitive impairment, planned relocation). Symptom duration
floor/ceiling adjustments: e.g., require ≥3 months for chronic tendinopathy studies; extend upper limit beyond 24
months if you want long-standing cases. Limit to a single site or unilateral disease to simplify ultrasound ROI
and analysis (exclude bilateral symptomatic cases unless you will treat only one side). Medication stability
window: require a stable analgesic/NSAID dose for the prior 2 weeks and throughout the study, or record doses
as covariates. Exclude prior major surgery at the same site (e.g., previous tendon repair) if it changes baseline
anatomy and imaging interpretation. Limit to certain imaging severity: e.g., include only PD grade 1–3 but
exclude structural grade indicating degeneration > specified threshold. Exclude diabetes with HbA1c > X if
wound healing or neuropathy is a concern.
10. Age subgroup restrictions (e.g., exclude >65) if device safety has not been tested in older adults.
Imaging-specific exclusions/requirements
1. Must have baseline ultrasound with documented PD grade and image that meets SOP (machine settings, ROI).
2. Exclude if baseline imaging shows a frank full-thickness tear, large retraction, or surgical hardware in the ROI.
3. Standardize timing: do not allow baseline ultrasound within 48 hours after injection or an intense physical
therapy session that could transiently alter vascularity.
Screening tests & baseline assessments
1. Targeted medical history/medications (recent steroids, biologics, anticoagulants).
2. Pregnancy test for women of childbearing potential.
3. Device/implant checklist (pacemaker, etc.).
4. Baseline ultrasound with standardized protocol (store images/DICOM).
5. Baseline VAS pain, validated functional score (VISA-A, WOMAC, etc.), and analgesic use log.
6. Safety labs only if clinically indicated (not routinely required).
Rationale & practical notes
1. Excluding recent local injections and recent systemic therapy changes is crucial because they produce large
imaging changes that confound treatment effect attribution to galvanic therapy.
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