Myofacial Pain SyndromeAI/CDMNCT07342790
Artificial Intelligence Clinical Decision
A study testing dry needling, neuromuscular facilitation (PNF) stretching and strengthening exercises (isometric & dynamic) in people with Myofacial Pain Syndrome and Clinical Decision Support, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofacial Pain Syndrome, Clinical Decision Support
- What is being tested?
- dry needling, neuromuscular facilitation (PNF) stretching and strengthening exercises (isometric & dynamic)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Outpatient clinic, faculty of physical therapy, Cairo university
Giza
About this study
Official title: Utilization of Artificial Intelligence in Supporting Physical Therapy Clinical Decision in Management of Myofascial Pain Syndrome Patients
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:
- Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on management of pain in myofascial pain syndrome.
- 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.
- Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on improving muscle strength in myofascial pain syndrome.
- 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.
- 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.
Read the 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
- Being tested
- dry needling, neuromuscular facilitation (PNF) stretching, strengthening exercises (isometric & dynamic), Transcutaneous electrical nerve stimulation, Ultrasound
- Keywords
- Clinical decision, artificial intelligence, pain, myofascial pain syndrome
- Medical subject headings
- Facial Neuralgia, Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingProcedure or surgery
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) stretchingOther
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)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 stimulationDevice
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.
UltrasoundDevice
Ultrasound is a therapeutic physical therapy modality which uses high frequency sound waves which are applied using coupling gel.
Hot packOther
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 exercisesOther
Stretching exercises are physical therapy interventions aimed at increasing muscle length and joint range of motion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Transcutaneous electrical nerve stimulation; Device: Ultrasound; Other: Hot pack; Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Functional level refers to a patient's ability to perform activities of daily living (ADLs) and special tasks which reflect overall physical capacity, independence, and quality of life. Patient-Specific Functional Scale (PSFS) allows participants to identify and rate specific activities that they find difficult due to their pain. They rate their ability to perform these activities on a scale from 0 (unable to perform) to 10 (able to perform at prior level). This instrument will evaluate functional improvement in daily living activities, customized to the unique limitations of each participant, offering a customized assessment of therapeutic success.
Measured: 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
The joint ROM refers to the extent of movement at a joint necessary to displace a bone within its spatial limits, Using Digital goniometer is an instrument used to measure and assessment of joint angles of the human body, in biomechanics, rehabilitation, and clinical research. Digital Goniometer is a new version alternative to the traditional mechanical goniometer that provides precise digital reading for angle measurement.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Mohamed Abousaida, Cairo University
- Investigators
- HESHAM M ABOUSAIDA, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342790
- Sponsor's protocol ID
- P.T.REC/012/006051
- Acronym
- AI/CDM
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Artificial Intelligence in Supporting Physical Therapy Clinical Decision in Management of Myofascial Pain Syndrome Patients
- ClinicalTrials.gov ID
- NCT07342790
- Acronym / sponsor ID
- AI/CDM / P.T.REC/012/006051
- Conditions
- Myofacial Pain Syndrome, Clinical Decision Support
- Keywords
- Clinical decision, artificial intelligence, pain, myofascial pain syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on management of pain in myofascial pain syndrome.
- 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.
- Compare the effectiveness of AI driven and human driven clinical decision in physical therapy clinical practice on improving muscle strength in myofascial pain syndrome.
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI.Group | Experimental | Procedure: dry needling, Other: neuromuscular facilitation (PNF) stretching, Other: strengthening exercises (isometric & dynamic), Device: Transcutaneous electrical nerve stimulationclinical 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 |
| Traditional Group | Experimental | Device: Transcutaneous electrical nerve stimulation, Device: Ultrasound, Other: Hot pack, Other: Stretching exercisesThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A- Demographic: Adult individuals 18-65 both sex
- Localized pain.
- Intensity: baseline pain score of 4 or higher on the VAS . C- Duration: chronic pain 3-6 months
- E- Daily Functioning limitations: moderate or severe
Key exclusion criteria (6 listed)
- • Severe cognitive impairment or illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingDry 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 | Procedure or surgery | AI.Group |
| neuromuscular facilitation (PNF) stretchingProprioceptive 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 | AI.Group |
| 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 | Other | AI.Group |
| Transcutaneous electrical nerve stimulationTranscutaneous 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 | AI.Group, Traditional Group |
| UltrasoundUltrasound is a therapeutic physical therapy modality which uses high frequency sound waves which are applied using coupling gel. | Device | Traditional Group |
| Hot packHot 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 | Traditional Group |
| Stretching exercisesStretching exercises are physical therapy interventions aimed at increasing muscle length and joint range of motion | Other | Traditional Group |
Primary outcome
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HESHAM M ABOUSAIDA, master principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling, neuromuscular facilitation (PNF) stretching and strengthening exercises (isometric & dynamic) in people with Myofacial Pain Syndrome and Clinical Decision Support, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HESHAM M ABOUSAIDA, master (00201003837815, h.mohamed851@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.