Artificial Intelligence Clinical Decision

Official title

Utilization of Artificial Intelligence in Supporting Physical Therapy Clinical Decision in Management of Myofascial Pain Syndrome Patients

Overview

The goal of this study is to investigate the effect of AI integration into clinical physical therapy clinical decision in improving cost effectiveness and clinical outcomes purposes of the study are: 1. Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on management of pain in myofascial pain syndrome. 2. Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on improving joint range of motion limitations in myofascial pain syndrome. 3. Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on improving muscle strength in myofascial pain syndrome. 4. Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on management of functional limitation in myofascial pain syndrome. 5. Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on cost-effectiveness in physical therapy management of myofascial pain syndrome.

Detailed description

Evaluation of AI impact on health care processes still needs more investigation whatever the review of literature reveals, there is a great interest in developing AI tools to support clinical workflows, with increasing high-quality evidence being generated. Investigation of the impact of AI integration into the process of physical therapy clinical decision-making in management of myofascial pain syndrome still not examined or tested. The study planned to compare the efficacy using AI model to support physical therapy decision based on clinical problems solving by evaluating clinical outcomes such as pain intensity, muscular strength, joint rang motion, functional level and therapeutic cost effective compared to traditional clinical decision in patient with myofascial pain syndrome. Formulation A well-established detailed input (prompt) created to guide ChatGPT to what is requested and the proper way to process through the input to develop comprehensive, multimodal approaches (different modalities categories as therapeutic exercises, electrotherapy, complementary and manual approaches when indicated, evidence-based physiotherapy treatment protocol for and planning therapeutic interventions based on studies from PEDro, PubMed, Cochrane, Scopus, and Google Scholar. Patients will be assigned to two groups; one receives AI based clinical decision therapeutic interventions compared to the other group which will receive a traditional intervention according to published methods. Outcomes measures will be assed to compare which is more effective and result in best outcomes and less cost. Trail expected to test if it's valuable to use AI module in data analysis to support choice effective intervention and test the concept based on patient clinical problem-solving approach in physical practice against previously tested traditional methods, additional benefits may provide an assessment of a trail to formulate successful prompt to be used in other conditions. Although there are many studies in supporting clinical decision, still there are many questions concerned with the validity , methods , efficacy , cost effectiveness , scope and ethics of application

Interventions

• Procedure dry needling
  Dry needling is a physical therapy intervention. It uses thin, solid filiform needles where no medication is injected, it targeting myofascial trigger points. The needle is inserted into the muscle tissue, and a local twitch response may occur which is considered a desired effect
• Other neuromuscular facilitation (PNF) stretching
  Proprioceptive neuromuscular facilitation stretching is a therapeutic stretching technique. It is commonly used in physical therapy and rehabilitation, involves stretching a target muscle , This is followed by an isometric or isotonic contraction
• Other strengthening exercises (isometric & dynamic)
  strengthening exercises are therapeutic interventions aiming to increase muscle strength and endurance. dynamic strengthening involves changes of the muscle length during contraction and isometric strengthening has no change of the muscle length
• Device Transcutaneous electrical nerve stimulation
  Transcutaneous electrical nerve stimulation is a non-invasive modality which is commonly used for pain management through delivering low-voltage electrical currents that applied through surface electrodes on the skin.
• Device Ultrasound
  Ultrasound is a therapeutic physical therapy modality which uses high frequency sound waves which are applied using coupling gel.
• Other Hot pack
  Hot pack therapy is a superficial heat modality used in physical therapy, applied for a controlled duration, 20 minutes with A protective layer (towel) is placed between the pack and skin to prevent burns
• Other Stretching exercises
  Stretching exercises are physical therapy interventions aimed at increasing muscle length and joint range of motion

Primary outcome measures

• Pain Intensity changing [Time frame: AI Group:12 sessions (1 every 3 days) Measures: Pre-1st, 4th,7th, 10th & post-12th session. Traditional Group:10 sessions/2weeks (5 daily, 2 days off, 5 daily)Measures: Pre-1st,4th,7th,10th & 2 days post-10th session]

Secondary outcome measures (2)

• Functional level Assessment [Time frame: AI Group:12 sessions (1 every 3 days) Measures: Pre-1st, 4th,7th, 10th & post-12th session. Traditional Group:10 sessions/2weeks (5 daily, 2 days off, 5 daily)Measures: Pre-1st,4th,7th,10th & 2 days post-10th session]
• Assessment of Joint Range Motion changes [Time frame: AI Group:12 sessions (1 every 3 days) Measures: Pre-1st, 4th,7th, 10th & post-12th session. Traditional Group:10 sessions/2weeks (5 daily, 2 days off, 5 daily)Measures: Pre-1st,4th,7th,10th & 2 days post-10th session]

Eligibility criteria

Inclusion criteria

• A- Demographic: Adult individuals 18-65 both sex

B- Pain Characteristics:

• Localized pain.
• Intensity: baseline pain score of 4 or higher on the VAS . C- Duration: chronic pain 3-6 months

D- Prescence of Myofascial Trigger Points (MTrPs):

E- Daily Functioning limitations: moderate or severe

Exclusion criteria

• • Severe cognitive impairment or illness.

• Recent history of major surgery or trauma (within 3 months).
• Other chronic conditions that could significantly interfere with the study.
• Patients with fibromyalgia which may have the Key Diagnostic Criteria for Fibromyalgia Syndrome:

• Widespread Pain Index (WPI) (appendix (2): Measures the number of painful areas across the body. A score of 7 or more indicates a higher likelihood of FMS (Wang et al. ,2025).
• Symptom Severity Scale (SSS) (appendix3): Assesses the severity of symptoms such as fatigue, sleep disturbances, and cognitive difficulties. A score of 5 or more is indicative of FMS

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Outpatient clinic, faculty of physical therapy, Cairo university — Giza

Identifiers

NCT: NCT07342790 · P.T.REC/012/006051

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗