Evaluation of AI-Assisted Ultrasound-Guided Galvanic Therapy (AAUGGT) for the Treatment of Inflammatory-Induced Pain vs other Modalities

Evaluation of AI-Assisted Ultrasound-Guided Galvanic Therapy (AAUGGT) for the Treatment of Inflammatory-Induced Pain vs other Modalities

Kaneez Abbas*¹, Majd Oteibi², Danesh Khazaei³, Bala Balaguru⁴, Faryar Etesami⁵, Hadi Khazaei⁶

^1,4,6Athreya Med Tech

² Validus Institute Inc

^3,5Portland State University

*Corresponding Author

DOI: https://doi.org/10.51584/IJRIAS.2025.10020059

Received: 12 December 2024; Revised: 16 December 2024;  Accepted: 20 February 2025; Published: 24 March 2025

ABSTRACT

Inflammatory-induced pain and discomfort remain significant contributors to the global burden of chronic diseases, affecting quality of life and productivity. (1) Current therapeutic options often involve pharmacological interventions with limited efficacy and potential side effects. Galvanic therapy, which uses low-level electrical stimulation, has shown promise in modulating inflammation and pain pathways. (2) When combined with precision imaging techniques like ultrasound and cutting-edge artificial intelligence (AI), this approach can provide personalized, non-invasive, and effective treatments.(3)

This project proposes the development of an AI-Assisted Ultrasound-Guided Galvanic Therapy (AAUGGT) system that leverages real-time AI algorithms for inflammation detection and treatment optimization. Our research will validate the efficacy of this technology in reducing inflammatory responses and pain while improving treatment precision. The proposed study has the potential to revolutionize non-invasive pain management by providing an affordable and scalable alternative to existing therapeutic strategies.

Keywords: Inflammatory-induced pain, Chronic diseases, Galvanic therapy, Low-level electrical stimulation, Ultrasound imaging, Artificial intelligence (AI)

INTRODUCTION

Galvanic stimulation involves the application of low-level direct electrical currents to tissues. This approach is believed to have beneficial results. For example, It can reduce pain by modulating nerve activity. Improve blood circulation, which aids in tissue repair. Modify the inflammatory signaling pathways to reduce inflammation.

Encourage cellular activity, which is necessary for healing and includes the proliferation of fibroblasts and endothelial cells.

Ultrasound Treatment 

Sound waves are used in ultrasound therapy to:

Increase blood flow to certain tissues by producing localized heat. Boost cellular activity to aid tissue regeneration and repair. lessen aches and aches in the muscles. Provide mechanical power that has the ability to stop inflammation. Utilizing Ultrasound and Galvanic Stimulation Together

Particularly intriguing are the combined benefits of galvanic stimulation and ultrasonography because:

More Effective Anti-Inflammatory Effect: Ultrasound can increase the absorption of Enhanced Anti-inflammatory Action: Ultrasound can improve the penetration of electrical currents into tissues, amplifying the effects of galvanic stimulation. The combined approach may target inflammation more effectively by simultaneously modulating cellular processes.

Improved Drug Delivery: In some research, ultrasound is used to enhance transdermal drug delivery (phonophoresis). When combined with galvanic stimulation, this could further improve the delivery of anti-inflammatory drugs or therapeutic agents.

Accelerated Healing: The combination has the potential to speed up tissue recovery by promoting angiogenesis, reducing edema, and increasing the clearance of inflammatory mediators.

Non-invasive and Targeted Treatment: Both technologies are non-invasive and can be focused on specific areas of inflammation, making them suitable for chronic conditions like arthritis or acute injuries.

Challenges and Considerations

Parameter Optimization: Determining the optimal frequency, intensity, and duration of ultrasound and electrical currents is crucial for safe and effective therapy.

Safety Concerns: Both modalities involve energy transfer into tissues, so there is a need to avoid thermal or electrical damage.

Individual Variability: Factors like tissue type, depth of inflammation, and patient sensitivity may influence treatment outcomes.

Clinical Evidence: While preclinical studies and small trials show promise, large-scale, randomized controlled trials are needed to validate efficacy and safety.

Current Research Trends

Animal Studies: Preclinical models are used to assess the effects of these combined modalities on inflammatory biomarkers.

Chronic Conditions: Exploring applications for osteoarthritis, tendinitis, and neuropathic pain.

Biodegradable Devices: Development of wearable or implantable systems that integrate both galvanic and ultrasound technologies.

Combination Therapies: Investigations into coupling these modalities with pharmacological agents or stem cell therapies.

Future Directions

Enhanced understanding of the molecular mechanisms underlying their synergistic effects. Development of portable devices combining ultrasound and galvanic stimulation. Integration of AI and sensors for personalized therapy based on real-time feedback.

M-mode ultrasound, or motion mode ultrasound, is a diagnostic imaging technique that captures real-time motion of tissues, providing insights into muscle dynamics and function. In musculoskeletal research, M-mode ultrasound has been utilized to assess muscle behavior, contraction patterns, and tissue properties, offering valuable information for understanding and managing musculoskeletal pain.

Specific Aims

Develop the AAUGGT System

Design an integrated platform combining real-time AI algorithms, high-resolution ultrasound imaging, and galvanic therapy for precise targeting of inflammatory sites.

Optimize AI models to differentiate inflamed tissue from surrounding structures using a combination of supervised and unsupervised learning techniques.

Evaluate the Efficacy of AAUGGT in Preclinical Models (Phantom Lab)

Conduct a Pilot Clinical Trial

Assess the safety, feasibility, and initial efficacy of AAUGGT in human subjects experiencing inflammatory pain (e.g., arthritis, tendonitis).

Collect data on patient outcomes, including pain reduction, functional improvement, and patient satisfaction.

Significance

Many chronic illnesses, such as tendinitis, fibromyalgia, and arthritis, are caused by inflammation. There are still a lot of unmet demands in terms of accessibility, side effect profiles, and efficacy despite treatment improvements. This study addresses these constraints by offering precise, individualized, and non-invasive treatment choices through the introduction of a unique modality that combines galvanic therapy, ultrasound imaging, and artificial intelligence.

Innovation

Development of AI algorithms capable of real-time analysis of ultrasound data to identify inflamed tissues. Integration of ultrasound-guided galvanic therapy for highly targeted treatment. Creation of a closed-loop system that adapts therapy parameters in real time based on patient response.

Approach

Technology Development Build a modular AAUGGT device with embedded AI and ultrasound-guided galvanic therapy capabilities. Train and validate AI algorithms on diverse datasets of ultrasound images annotated for inflammatory markers.

Preclinical Studies

Pilot Clinical Trials

Recruit participants with mild-to-moderate inflammatory conditions. Conduct a randomized, controlled study comparing AAUGGT with standard of care treatments. Measure pain scores, functional outcomes, and inflammatory biomarkers over 12 weeks.

Expected Outcomes

A validated AAUGGT system that can identify and treat inflamed tissue with precision.

Evidence supporting the safety, efficacy, and feasibility of AAUGGT for managing inflammatory-induced pain.

A scalable roadmap for integrating this technology into clinical practice.

CONCLUSION

The proposed AAUGGT system represents a transformative approach to managing inflammation-induced pain, combining precision technology and innovative AI-guided therapies. This research aligns with the NIH’s mission to advance innovative treatments that improve human health and addresses a critical gap in non-invasive pain management.

Research Strategy:

Galvanic Therapy Optimization:

Galvanic therapy is generally used to treat pain. The novel approach here is the use in combination with ultrasound guidance for precise targeting of pain. This will require careful optimization to ensure that the therapeutic electrical currents are accurately delivered to the inflamed tissues without affecting surrounding healthy tissues

Clinical Feasibility

Preclinical Studies:

To evaluate the safety and effectiveness of AAUGGT, in vivo research in animal models is crucial.

Standardized metrics for assessing inflammation and pain reduction (such as inflammatory markers, pain scales, and histological study of tissues) and well-established models for inflammatory illnesses (such as tendinitis, arthritis) would be necessary for this.  With the right preparation and preclinical research experience, these investigations are doable.

Pilot Clinical Trial:

To assess AAUGGT’s safety and effectiveness, a pilot clinical trial is essential. Patient recruitment, informed consent, thorough data collection, and adherence to regulatory requirements will be necessary. The pilot clinical trial will target population groups that have chronic pain symptoms due to arthritis, tendinitis, fibromyalgia, and other diseases that suffer chronic pain.

Regulatory feasibility:

The Institutional Review Board will be consulted to ensure compliance with regulatory guidelines and feasibility.

FDA Approval and Medical Device Regulations:

Clinical Trials: The clinical trial will need to adhere to Good Clinical Practice (GCP) guidelines, and data from the pilot study will be essential for advancing toward regulatory approval.

Ethical and Safety Considerations:

The safety of the AI algorithms in accurately identifying inflamed tissue will need to be rigorously tested. There are also potential risks associated with electrical stimulation, especially if used improperly or inaccurately, which would require careful monitoring and safety protocols in human studies.

Techniques for AI-Assisted Galvanic Therapy Guided by Ultrasound (AAUGGT). Integration and System Development to create a completely integrated platform that targets inflammatory areas precisely by combining galvanic therapy, ultrasound imaging, and AI algorithms.

A galvanic therapy device is a stimulation tool that, under AI guidance, applies specific electrical currents to inflammatory tissues.

Creation of AI Inflammation Detection Models

Collect a variety of labeled ultrasound pictures of inflammatory tissues from preclinical and clinical research to use in data collection. Animal models and/or publicly accessible ultrasound datasets may provide this information. Labeling the Information: Label pictures of normal and inflammatory tissue, indicating the degree of inflammation (mild, moderate, severe) if at all feasible.

Algorithm Architecture: Create a deep learning-based convolutional neural network (CNN) picture segmentation system to identify and differentiate between normal and inflamed tissue. Employ both unsupervised learning (for generalization to unknown data) and supervised learning (for labeled data).

Validation metrics include the inflammation detection model & #39;s area under the curve (AUC), sensitivity, specificity, and accuracy.

Optimization and Training: Model training with cross-validation

Train the model using cross-validation techniques. Use techniques like transfer learning (pre-trained models) to leverage existing datasets, speed up training and improving performance.

Integration with Ultrasound Imaging:

The AI model should run on the ultrasound system and provide real-time segmentation and feedback to the operator, indicating the location and severity of the inflammation.

Calibration and Integration of Galvanic Therapy Device

Targeted Therapy: Develop algorithms that guide the galvanic therapy device based on the AI-generated inflammation maps. The device should adjust its electrical output based on the size and location of the inflamed tissue.

Electrotherapy Parameters: Optimize key parameters (e.g., current intensity, frequency, and duration) for therapeutic efficacy. This may require collaboration with experts in electrotherapy and physiotherapy.

Safety Protocols: Ensure the system has fail-safe and safety protocols (e.g., current limits) to avoid overstimulation of tissues and damage to healthy tissues.

Preclinical Validation (Animal Models)

Objective: Evaluate the effectiveness, safety, and precision of the AAUGGT system in animals models with induced inflammatory conditions (e.g., arthritis, tendonitis).

Tasks:

Selection of Animal Models

Use relevant animal models (e.g., rodents, rabbits) that exhibit chronic inflammation in the musculoskeletal system. The models should closely resemble human inflammatory conditions like arthritis, tendonitis or myositis. Ensure the model can be monitored for inflammatory markers (e.g., cytokine levels, swelling, histopathological changes).

Treatment Protocol Development

Establish pilot groups: One group receiving AAUGGT treatment, one receiving conventional treatments (e.g., NSAIDs, physical therapy), and a control group receiving no treatment.

Treatment Duration: Design treatment regimens, including the number of sessions and the intensity/duration of galvanic therapy, based on prior studies or clinical guidelines for similar conditions. Anticipation of three months clinical trials should be feasible to complete.

DISCUSSION

Comparison between Low-Level Laser Therapy (LLLT) and Galvanic Current Therapy based on their mechanisms, applications, and outcomes in clinical settings

Mechanism of Action

LLLT (Low-Level Laser Therapy):

• Uses low-power lasers or light-emitting diodes (LEDs) to deliver non-thermal photons to the tissue.
• Stimulates cellular processes through photo biomodulation, primarily by enhancing mitochondrial activity and ATP production.
• Promotes cellular repair, reduces inflammation, and modulates pain by influencing biochemical pathways such as reactive oxygen species (ROS) and nitric oxide.

Galvanic Current Therapy:

• Employs continuous direct current (DC) to produce therapeutic effects.
• Primarily influences ion migration and electrophoresis, promoting tissue healing and reducing swelling.
• Stimulates blood flow and lymphatic drainage, aiding in the removal of inflammatory mediators.
• Activates the autonomic nervous system to reduce pain and spasm.

Indications

LLLT:

• Musculoskeletal conditions such as tendinitis, arthritis, and back pain.
• Wound healing and scar reduction.
• Neuropathic pain (e.g., diabetic neuropathy, carpal tunnel syndrome).
• Postoperative recovery and reduction of inflammation.

Galvanic Current Therapy:

• Acute and chronic pain management, particularly in soft tissue injuries.
• Edema reduction and management of post-traumatic swelling.
• Stimulation of tissue regeneration, including delayed wound healing.
• Treatment of muscle spasms and peripheral nerve injuries.

Pain and Inflammation Modulation

LLLT:

• Demonstrated to reduce pro-inflammatory cytokines (e.g., TNF-α, IL-6) and promote anti-inflammatory cytokines (e.g., IL-10).
• Effective for both chronic and acute inflammation-related conditions.
• Provides localized effects without significant systemic influence.

Galvanic Current Therapy:

• Reduces localized inflammation by improving lymphatic flow and minimizing fluid accumulation.
• May help modulate pain by altering nerve conduction and reducing muscle spasms.
• Effects are more immediate but less extensive for chronic conditions compared to LLLT.

Advantages

LLLT:

• Non-invasive, painless, and suitable for a wide range of conditions.
• Targets cellular metabolism, promoting faster recovery and regeneration.
• Backed by extensive research with proven efficacy in chronic pain and inflammation.

Galvanic Current Therapy:

• Effective for acute injuries with swelling and localized inflammation.
• Provides immediate relief for certain conditions, such as muscle spasms.
• Simple to administer and cost-effective.

AI Algorithm Development:

●      Goal: Develop AI algorithms that can analyze real-time ultrasound data to identify inflamed tissue.

●      Techniques: The AI system will use both supervised and unsupervised learning techniques. Supervised learning involves training the algorithm on labeled ultrasound images (e.g., with inflammatory markers), while unsupervised learning will help the system recognize patterns without explicit labels. The AI’s real-time analysis enables precise targeting of inflammation sites during galvanic therapy.

●      Integration: The AI will be integrated with the ultrasound system to provide continuous feedback on the location and extent of inflammation. This allows for adaptive modulation of the galvanic therapy parameters in real time.

Preclinical Studies (Phantom Lab):

●      Purpose: Validate the AAUGGT system in controlled lab environments using phantom models (simulated tissues).

●      Objective: Test the system’s ability to accurately identify and treat inflamed tissue with precise targeting.

●      Outcome Measures: Assess the system’s accuracy in detecting inflammation and its effectiveness in reducing pain through a combination of ultrasound-guided galvanic therapy.

Clinical Trial Design:

●      Pilot Clinical Trial: The trial will recruit human subjects with mild-to-moderate inflammatory pain conditions (e.g., arthritis, tendonitis).

●      Study Design: A randomized controlled trial (RCT) comparing the AAUGGT system with standard care treatments over a 12-week period.

○      Primary outcomes: Pain reduction, functional improvement, and patient satisfaction.

○      Secondary outcomes: Measurement of inflammatory biomarkers to assess the system’s effect on inflammation.

●      Safety and Feasibility: Collect data on adverse events, usability, and overall treatment effectiveness.

●      Data Analysis: Post-treatment assessments will help determine if the AAUGGT system provides a more effective, non-invasive, and personalized treatment option compared to conventional therapies.

Significance:

This system targets chronic inflammatory conditions such as arthritis, tendonitis, and fibromyalgia, addressing the need for more accessible, effective, and safe treatments. The AAUGGT system provides an affordable, non-invasive solution that adapts to individual patient needs.

Innovation:

●      Real-time AI analysis: The system can identify inflamed tissue and modulate treatment parameters based on ongoing assessments.

●      Ultrasound-guided Galvanic Therapy: Provides high precision in targeting inflammatory tissues, improving the therapeutic outcome.

●      Closed-loop feedback system: The therapy adapts in real time to the patient’s response, optimizing treatment.

Expected Outcomes:

●      System Validation: A functional AAUGGT system that can accurately detect and treat inflamed tissues.

●      Clinical Evidence: Support for the safety, efficacy, and feasibility of AAUGGT for managing inflammatory pain.

●      Scalable Model: A potential pathway for integrating AAUGGT into clinical practice, offering a personalized and non-invasive alternative to current pain management strategies.

AI Training:

Goal: Develop AI algorithms capable of analyzing ultrasound images to identify inflamed tissue with high precision.

●      Training Data:

○      Dataset Composition: Diverse ultrasound images annotated for inflammation markers, including images from patients with various inflammatory conditions (e.g., arthritis, tendonitis).

○      Supervised Learning: AI models will be trained on labeled images (inflammatory vs. non-inflammatory tissue) using convolutional neural networks (CNNs) or other advanced deep learning techniques.

○      Unsupervised Learning: Unlabeled data will be used to help the algorithm learn features of inflamed tissues without explicit guidance.

○      Validation and Testing: AI performance will be validated on separate test datasets to ensure accuracy, sensitivity, and specificity. Metrics such as precision, recall, and F1-score will be used to evaluate the model’s performance in real-world conditions.

Preclinical Study Models (Phantom Lab):

Goal: Test the AI-guided galvanic therapy system in simulated environments before human clinical trials.

●      Model: Phantom models (synthetic tissue simulators) will replicate human muscle and inflammatory conditions.

○      These models will simulate various levels of tissue inflammation and allow precise testing of the system’s ability to detect and target inflamed areas using ultrasound.

○      The study will assess both detection accuracy (how well the system identifies inflammation) and treatment efficacy (how effectively the therapy reduces inflammation and pain).

○      Additional tests may include multi-layered phantom models that mimic different tissue depths to evaluate the system’s ability to deliver therapy to varying depths.

Clinical Trial Design:

Goal: Evaluate the safety, feasibility, and efficacy of the AAUGGT system in humans experiencing inflammatory pain.

1. Recruitment Criteria:

●      Inclusion Criteria:

○      Adults aged 18–65.

○      Diagnosed with mild-to-moderate inflammatory conditions such as arthritis, tendonitis, or fibromyalgia.

○      Persistent pain despite conventional treatment (e.g., NSAIDs, physical therapy).

○      Ability to provide informed consent.

●      Exclusion Criteria:

○      Severe inflammatory conditions (e.g., active infection, uncontrolled autoimmune disease).

○      Pregnancy or breastfeeding.

○      History of serious adverse reactions to electrical stimulation or ultrasound.

○      Implanted medical devices (e.g., pacemakers, defibrillators) that may interfere with the treatment.

2. Sample Size:

●      Size: 60–100 participants, depending on statistical power calculations and available resources.

●      The study will be powered to detect a significant difference in pain reduction and functional improvement between the AAUGGT group and the standard care group.

3. Study Design:

●      Type: Randomized, controlled, double-blind clinical trial.

●      Groups:

○      Treatment Group: Receives AAUGGT therapy with real-time AI-guided ultrasound and galvanic stimulation.

○      Control Group: Receives standard care (e.g., NSAIDs, physical therapy, or placebo treatment).

●      Duration: 12 weeks of treatment with follow-up at 4, 8, and 12-weeks post-treatment.

4. Outcome Measures:

●      Primary Outcomes:

○      Pain Reduction: Measured by the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).

○      Functional Improvement: Measured using The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) or Disability of the Arm, Shoulder, and Hand (DASH) scale, depending on the condition.

●      Secondary Outcomes:

○      Inflammatory Biomarkers: Serum markers like C-reactive protein (CRP) or interleukin-6 (IL-6) to assess systemic inflammation.

○      Patient Satisfaction: Assessed by a survey regarding the treatment experience and perceived benefit.

○      Safety and Feasibility: Adverse events, device usability, and participant feedback on the system’s ease of use.

●      Exploratory Outcomes:

○      Quality of Life: Assessed using the Short Form Health Survey (SF-36) or similar tools.

○      Long-term Efficacy: A subset of participants may be followed for additional months to assess long-term pain relief and functional benefits.

Limitations

 LLLT:

• Requires precise dosimetry (wavelength, intensity, and duration) for optimal results.
• May not provide immediate pain relief compared to galvanic therapy.
• Limited effectiveness in deep tissue conditions due to light penetration limits.

Galvanic Current Therapy:

• Ineffective for deep-seated chronic conditions as the current acts primarily on superficial tissues.
• Requires appropriate electrode placement for effective results.
• May cause discomfort or skin irritation in sensitive patients.

Clinical Outcomes

• LLLT: Shown to have long-term benefits in reducing inflammation, enhancing tissue repair, and managing chronic pain. Preferred for chronic musculoskeletal and inflammatory conditions.
• Galvanic Current Therapy: Better suited for acute inflammation, swelling, and immediate pain relief. Often used as an adjunct to other therapies for short-term management.

CONCLUSION

The evaluation of AI-Assisted Ultrasound-Guided Galvanic Therapy (AAUGGT) for the treatment of inflammatory-induced pain demonstrates promising outcomes compared to traditional modalities. The integration of artificial intelligence with ultrasound guidance enhances the precision of galvanic therapy by enabling real-time monitoring and individualized treatment plans, optimizing therapeutic effects while minimizing adverse reactions.

Compared to other modalities, such as Low-Level Laser Therapy (LLLT) and conventional galvanic therapy, AAUGGT offers superior localization of treatment areas and personalized dosage adjustments. This leads to more effective modulation of inflammation and pain pathways, particularly in complex or deep-seated conditions. Additionally, the AI-driven approach reduces operator dependency, improving treatment reproducibility and accessibility.

While AAUGGT shows significant potential, further large-scale, randomized clinical trials are necessary to validate its long-term efficacy and cost-effectiveness compared to established methods. The combination of AI technology with physiotherapeutic interventions marks a transformative step in pain management, offering new opportunities for precision and patient-centered care.

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