Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture

Conditions

• Bone Fracture
• Fresh Fracture

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Sustained Acoustic Device with 2.5% Diclofenac Patch — DEVICE
  Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3-megahertz (MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
• 2.5% Diclofenac Patches — DRUG
  Topical pain relief-gel worn during treatment via SAM patch.

Study Details

The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.

Key Dates

Start date

Jun 1, 2023

Status verified

Feb 2025

Primary completion

Feb 1, 2026

Completion

Feb 28, 2026

Study Design

Enrollment

90 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: SAM Ultrasound Device and Diclofenac Patch
  Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm\^2 intensity.

Primary Outcome Measure

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline [ Time Frame: Through study completion, average of 12 weeks. ]

Central Contacts

• George K. Lewis, Ph.D.
  8882029831
  [email protected]

Locations (2)

Find similar trials in Trumbull, CT

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