Artificial Intelligence Clinical Decision

NCT ID: NCT07342790

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-04-01

Brief Summary

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

Conditions

Myofacial Pain Syndrome; Clinical Decision Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AI.Group

clinical decision making will depend on the integration of ChatGPT 4 into clinical decision-making process as a clinical advisor which recommends application of modalities based on clinical problems as follows dry needling for pain management, proprioceptive neuromuscular facilitation (PNF) stretching for muscle \& joint rom enhancement, strengthening exercises (isometric \& dynamic) for functional improvement and TENS (transcutaneous electrical nerve stimulation) in addition to home exercises as adjuvant therapies \& ergonomic education

Group Type: EXPERIMENTAL

dry needling

Intervention Type: PROCEDURE

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

neuromuscular facilitation (PNF) stretching

Intervention Type: OTHER

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

strengthening exercises (isometric & dynamic)

Intervention Type: OTHER

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

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

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.

Traditional Group

The traditional physical therapy treatment regime consists of hot pack (HP), transcutaneous electrical nerve stimulation (TENS), and ultrasound (US) for five days a week for two weeks, Application rules were:

• Ultrasound (US): Continuous US at a frequency of 1 MHz was applied at a dose of 1.5 watt/cm² for six minutes daily.
• Transcutaneous Electrical Nerve Stimulation (TENS): TENS was applied for 30 minutes daily.
• Hot Pack (HP): HP was applied for 20 minutes daily.
• In addition to these modalities, stretching exercises affected muscles

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

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.

Ultrasound

Intervention Type: DEVICE

Ultrasound is a therapeutic physical therapy modality which uses high frequency sound waves which are applied using coupling gel.

Hot pack

Intervention Type: OTHER

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

Stretching exercises

Intervention Type: OTHER

Stretching exercises are physical therapy interventions aimed at increasing muscle length and joint range of motion

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: 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

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Ultrasound

Ultrasound is a therapeutic physical therapy modality which uses high frequency sound waves which are applied using coupling gel.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Stretching exercises

Stretching exercises are physical therapy interventions aimed at increasing muscle length and joint range of motion

Intervention Type: OTHER

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:

1. 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).

2. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hesham Mohamed Mohamed Abousaida

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HESHAM M ABOUSAIDA, master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic, faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Central Contacts

HESHAM M ABOUSAIDA, master

Role: CONTACT

h.mohamed851@yahoo.com

00201003837815

Noran El-Behary, PHD

Role: CONTACT

noranelbehary@yahoo.com

00201008423350

Other Identifiers

P.T.REC/012/006051

Identifier Type: -

Identifier Source: org_study_id