Artificial Intelligence Clinical Decision

NCT07342790 | Not Yet Recruiting DMC

• 1 other identifier: P.T.REC/012/006051
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 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.

Conditions

Clinical Decision Support; Myofacial Pain Syndrome

Keywords

Clinical decision; artificial intelligence; pain; myofascial pain syndrome

Outcome Measures

Primary Outcomes (1)

• Pain Intensity changing

  Pain intensity is a subjective measurement of pain level or magnitude that can be Measured using a visual analog scale (VAS) , which is a tool used for measuring intensity of pain. It consists of a 10-centimeter line with endpoints defining extremes of pain (e.g., "no pain" to "worst possible pain"). A quantitative indicator of pain intensity will be provided by participants marking their level of pain on the line.

  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 Outcomes (2)

• Functional level Assessment

  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

  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

Study Arms (2)

AI.Group

EXPERIMENTAL

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

Procedure: dry needling; Other: neuromuscular facilitation (PNF) stretching; Other: strengthening exercises (isometric & dynamic); Device: Transcutaneous electrical nerve stimulation

Traditional Group

EXPERIMENTAL

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

Device: Transcutaneous electrical nerve stimulation; Device: Ultrasound; Other: Hot pack; Other: Stretching exercises

Interventions

dry needling 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

AI.Group

strengthening exercises (isometric & dynamic) 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

AI.Group

Transcutaneous electrical nerve stimulation 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.

AI.Group; Traditional Group

Ultrasound DEVICE

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

Traditional Group

Hot pack 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

Traditional Group

Stretching exercises OTHER

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

Traditional Group

neuromuscular facilitation (PNF) stretching 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

AI.Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic, faculty of physical therapy, Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Facial Neuralgia; Pain; Myofascial Pain Syndromes

Interventions

Dry Needling; Muscle Stretching Exercises; Transcutaneous Electric Nerve Stimulation; Ultrasonography

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• HESHAM M ABOUSAIDA, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HESHAM M ABOUSAIDA, master

CONTACT

00201003837815; h.mohamed851@yahoo.com

Noran El-Behary, PHD

CONTACT

00201008423350; noranelbehary@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)