Myofascial Pain Syndrome (MPS)IMPACT-MPSNCT07494162
Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome
A study testing Acupuncture and Total-Body PET/CT Imaging in people with Myofascial Pain Syndrome (MPS) and Chronic Low-back Pain (cLBP), run by University of California, Davis at 1 site in United States.
Trial summary
This study will evaluate the clinical and biological effects of acupuncture for chronic low back pain associated with myofascial pain syndrome (MPS). In this randomized, participant- and assessor-blinded clinical trial, 64 adults with chronic low back pain due to MPS will be assigned to receive either true acupuncture… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome (MPS), Chronic Low-back Pain (cLBP)
- What is being tested?
- Acupuncture and Total-Body PET/CT Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to Apr 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand the purposes and risks of the trial and willingness to sign an informed consent form
- Willingness and ability to comply with all protocol required procedures
- Willingness to be randomized to receive either true acupuncture or sham acupuncture
- Current self-report of chronic low back pain (cLBP) which has persisted for the past 3 months AND has resulted in pain on > 50% of days in the past 6 months
- At least one palpable nodule or taut band in paraspinal, quadratus lumborum, or gluteal muscles
- Reproduction of the patient's dominant pain with palpation of a muscle nodule or taut band
Show all 11Show fewer
- Predominantly paramedian pain (may be uni-lateral or bi-lateral)
- Willing and able to lay motionless in a supine position at least twice, preferably thrice: 70-minute TB-PET/CT scan
- Willing and able to fast for at least 6 hours before and for the duration of the TB-PET/CT scan
- Willing to avoid strenuous exercise for 24 hours before the TB-PET/CT scan visit
- Willingness to practice effective contraception during the study.
Who cannot join
- No Primary Care Physician
- History of spine infection (discitis or osteomyelitis) or spine tumor
- History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus
- Confounding conditions that are known to be responsible for inducing pain
- Implants at or in the region of the sites of interest
- Diagnosis of any vertebral fracture in the last 6 months
Show all 20Show fewer
- Cauda equina syndrome or lumbar radiculopathy with functional motor deficit (strength<4/5 on manual motor testing)
- Spinal implants (including fixation hardware, spinal cord stimulator, intra-thecal pumps, that are present in the region of the sites of interest)
- Predominantly central pain
- Pain below the knee
- Positive straight leg raise test
- Symptomatic hip arthritis
- Uncontrolled claustrophobia
- Pregnant or lactating participants
- Body weight more than 225 kg (496 pounds) due to the weight limitation of the scanner bed
- Prisoners
- Inability to speak, read, and write in the English language
- Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
- That is, PET scans are not performed as part of a patient's treatment plan (e.g. standard of care, therapeutic purposes, or clinical care) and the research study did not intend to provide therapeutic benefit to the patient.
- •Any other criteria, which would make the participant unsuitable to participate in this study as determined by the Principal Investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, 95816
Clinical Research Coordinator Team, 916-731-9004, Research-radiology-som@health.ucdavis.edu
Abhijit J Chaudhari, PhD
About this study
Official title: IMPACT-MPS: Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome
This study will evaluate the clinical and biological effects of acupuncture for chronic low back pain associated with myofascial pain syndrome (MPS).
In this randomized, participant- and assessor-blinded clinical trial, 64 adults with chronic low back pain due to MPS will be assigned to receive either true acupuncture or sham acupuncture for eight weeks. Participants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging and complete standardized pain and functional questionnaires at baseline and after treatment.
The study will evaluate whether acupuncture improves pain and function compared with sham treatment and whether TB-PET/CT imaging can detect changes in myofascial tissue metabolism and perfusion that correspond with clinical outcomes.
Read the detailed description
Myofascial pain syndrome (MPS) is a musculoskeletal pain disorder characterized by localized muscle pain, trigger points, and functional limitations. MPS is frequently associated with chronic low back pain and contributes substantially to reduced quality of life and increased healthcare utilization. Despite its prevalence, diagnosis and treatment monitoring rely largely on subjective clinical examination and patient-reported outcomes because validated objective biomarkers of myofascial tissue dysfunction are lacking.
Acupuncture is widely used as a non-pharmacologic treatment for chronic pain and has demonstrated benefit in several chronic low back pain studies. However, the biological mechanisms underlying acupuncture's therapeutic effects remain poorly understood, in part because objective measures of tissue-level response are limited.
Total-body positron emission tomography/computed tomography (TB-PET/CT) is a highly sensitive molecular imaging technique capable of assessing metabolic activity and blood flow throughout the body. Recent observational work using TB-PET/CT has demonstrated the ability to differentiate painful myofascial tissue from non-painful tissue, suggesting that this technology may provide quantitative biomarkers of myofascial dysfunction.
The IMPACT-MPS study is a two-arm, randomized, participant- and assessor-blinded, sham-controlled clinical trial designed to evaluate both the clinical efficacy of acupuncture and the utility of TB-PET/CT imaging biomarkers in MPS. A total of 64 adults with chronic low back pain associated with myofascial pain syndrome will be enrolled and randomized in a 1:1 ratio to receive either standardized acupuncture treatment or sham acupuncture.
Participants will receive up to three acupuncture or sham sessions per week for eight weeks. TB-PET/CT imaging and patient-reported outcome assessments will be performed at baseline and at 8 weeks, with an optional imaging and assessment visit at week 4. Clinical outcomes will include standardized pain and function measures, including the PEG (Pain intensity, Enjoyment of life, General activity) scale and other NIH HEAL Common Data Elements.
The primary clinical endpoint is the change in PEG score from baseline to 8 weeks. The primary imaging endpoint is the change in standardized uptake values in predefined myofascial regions of interest measured by TB-PET/CT. Secondary outcomes include additional patient-reported outcomes and imaging measures of myofascial tissue metabolism and perfusion.
This study aims to determine whether acupuncture improves clinical outcomes in patients with myofascial pain syndrome and to evaluate TB-PET/CT as an objective imaging biomarker of myofascial tissue dysfunction and treatment response. The results may support the development of imaging-based tools for evaluating chronic musculoskeletal pain and monitoring treatment effects.
- Being tested
- Acupuncture, Sham Acupuncture, Total-Body PET/CT Imaging
- Keywords
- acupuncture treatment, Total-Body PET, FDG PET, Myofascial Pain Syndrome, Chronic Low Back Pain, Imaging Biomarkers
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Participants assigned to the acupuncture group will receive standardized acupuncture treatments administered by a licensed acupuncturist. Treatments will occur up to three times per week for eight weeks (maximum of 24 sessions).
Sham AcupunctureProcedure or surgery
Participants assigned to the sham control group will receive sham acupuncture using non-penetrating placebo needles designed to mimic the appearance and sensation of acupuncture without skin penetration. Sessions will occur up to three times per week for eight weeks (maximum of 24 sessions) and will follow procedures similar in duration and setting to the acupuncture intervention.
Total-Body PET/CT ImagingProcedure or surgery
Participants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging using 18F-fluorodeoxyglucose (18F-FDG). Imaging will be performed at baseline (prior to the first acupuncture/sham acupuncture) and at 8 weeks (after the last acupuncture/sham acupuncture session), with an optional mid-treatment scan at 4 weeks, to evaluate metabolic activity and perfusion in myofascial tissue.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Participants randomized to the experimental arm will receive standardized acupuncture treatment up to three sessions per week for eight weeks (maximum of 24 sessions) administered by a licensed acupuncturist. Receives: Procedure: Acupuncture; Procedure: Total-Body PET/CT Imaging |
| Sham Acupuncture | Sham comparator | Participants randomized to the control arm will receive sham acupuncture using non-penetrating needles designed to mimic acupuncture procedures without therapeutic needle penetration. Receives: Procedure: Sham Acupuncture; Procedure: Total-Body PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PEG score from Baseline to 8 weeks
Change in PEG (Pain intensity, Enjoyment of life, General activity) score from baseline to 8 weeks. The PEG is a 3-item patient-reported outcome measure assessing pain intensity and pain interference with enjoyment of life and general activity. Higher scores indicate worse pain severity and interference. This is the primary clinical endpoint.
Measured: Baseline and 8 weeks post-intervention
Change in Standardized Uptake Values in Myofascial Regions of Interest on TB-PET/CT from Baseline to 8 weeks
Change in standardized uptake values (SUV) in predefined myofascial regions of interest as measured by total-body positron emission tomography/computed tomography (TB-PET/CT) from baseline to 8 weeks. This is the primary imaging endpoint.
Measured: Baseline and 8 weeks post-intervention
Secondary outcomes (7)
Percent Change in PET-Derived K1 Perfusion (mL/min/g) Averaged Across Predefined Myofascial Regions of Interest
K1 perfusion parameter (mL/min/g), representing tracer delivery and tissue blood flow, will be quantified using total-body PET/CT in predefined myofascial regions of interest (ROIs). For each participant, K1 values will be calculated for each ROI and averaged across all predefined ROIs to generate a single summary value per timepoint. The outcome measure is the percent change in mean K1 from baseline to 8 weeks post-intervention.
Measured: Baseline and 8 weeks post-intervention
Change in PROMIS Sleep Disturbance Short Form 6a T-Score
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance Short Form 6a will be used to assess sleep disturbance. Responses are converted to a standardized T-score (range 0-100), where higher scores indicate greater sleep disturbance. The outcome measure is the change in T-score from baseline to 8 weeks post-intervention.
Measured: Baseline and 8 weeks post-intervention
Change in Pain Catastrophizing Scale - Short Form 6 Score
Change in Pain Catastrophizing Scale Short Form 6 score from baseline to 8 weeks. Scores range from 0-24 with higher scores indicating greater pain catastrophizing.
Measured: Baseline and 8 weeks post-intervention
Patient Global Impression of Change at 8 Weeks
Participant-reported Patient Global Impression of Change (PGIC) at 8 weeks following treatment. Scores range from 1 to 7, with higher scores indicating worsening.
Measured: 8 weeks post-intervention
Change in Patient Health Questionnaire-2 Score
Change in Patient Health Questionnaire-2 (PHQ-2) score from baseline to 8 weeks. The PHQ-2 assesses depressive symptoms over the past two weeks. Scores range from 0-6, with higher scores indicating greater depressive symptom severity.
Measured: Baseline and 8 weeks post-intervention
Change in Generalized Anxiety Disorder-2 Score
Change in Generalized Anxiety Disorder-2 (GAD-2) score from baseline to 8 weeks. Scores range from 0-6, with higher scores indicating greater anxiety symptom severity.
Measured: Baseline and 8 weeks post-intervention
Change in TAPS-1 Score
Change in Tobacco, Alcohol, Prescription medications, and other Substances (TAPS-1) screening score from baseline to 8 weeks. This is a 4-item screen for tobacco, alcohol, illicit drugs, and non-medical use of prescription drugs, askign about frequency of use with higher scores indicating increased risk for substance use disorder.
Measured: Baseline and 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start18 May 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome (MPS)Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Abhijit J Chaudhari, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494162
- Sponsor's protocol ID
- 2344364
- Other IDs
- R33AT012187
- Acronym
- IMPACT-MPS
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT-MPS: Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT07494162
- Acronym / sponsor ID
- IMPACT-MPS / 2344364
- Keywords
- acupuncture treatment, Total-Body PET, FDG PET, Myofascial Pain Syndrome, Chronic Low Back Pain, Imaging Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Study start
- 18 May 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 27 Mar 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.
This study will evaluate the clinical and biological effects of acupuncture for chronic low back pain associated with myofascial pain syndrome (MPS).
In this randomized, participant- and assessor-blinded clinical trial, 64 adults with chronic low back pain due to MPS will be assigned to receive either true acupuncture or sham acupuncture for eight weeks. Participants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging and complete standardized pain and functional questionnaires at baseline and after treatment.
The study will evaluate whether acupuncture improves pain and function compared with sham treatment and whether TB-PET/CT imaging can detect changes in myofascial tissue metabolism and perfusion that correspond with clinical outcomes.
Detailed description
Myofascial pain syndrome (MPS) is a musculoskeletal pain disorder characterized by localized muscle pain, trigger points, and functional limitations. MPS is frequently associated with chronic low back pain and contributes substantially to reduced quality of life and increased healthcare utilization. Despite its prevalence, diagnosis and treatment monitoring rely largely on subjective clinical examination and patient-reported outcomes because validated objective biomarkers of myofascial tissue dysfunction are lacking.
Acupuncture is widely used as a non-pharmacologic treatment for chronic pain and has demonstrated benefit in several chronic low back pain studies. However, the biological mechanisms underlying acupuncture's therapeutic effects remain poorly understood, in part because objective measures of tissue-level response are limited.
Total-body positron emission tomography/computed tomography (TB-PET/CT) is a highly sensitive molecular imaging technique capable of assessing metabolic activity and blood flow throughout the body. Recent observational work using TB-PET/CT has demonstrated the ability to differentiate painful myofascial tissue from non-painful tissue, suggesting that this technology may provide quantitative biomarkers of myofascial dysfunction.
The IMPACT-MPS study is a two-arm, randomized, participant- and assessor-blinded, sham-controlled clinical trial designed to evaluate both the clinical efficacy of acupuncture and the utility of TB-PET/CT imaging biomarkers in MPS. A total of 64 adults with chronic low back pain associated with myofascial pain syndrome will be enrolled and randomized in a 1:1 ratio to receive either standardized acupuncture treatment or sham acupuncture.
Participants will receive up to three acupuncture or sham sessions per week for eight weeks. TB-PET/CT imaging and patient-reported outcome assessments will be performed at baseline and at 8 weeks, with an optional imaging and assessment visit at week 4. Clinical outcomes will include standardized pain and function measures, including the PEG (Pain intensity, Enjoyment of life, General activity) scale and other NIH HEAL Common Data Elements.
The primary clinical endpoint is the change in PEG score from baseline to 8 weeks. The primary imaging endpoint is the change in standardized uptake values in predefined myofascial regions of interest measured by TB-PET/CT. Secondary outcomes include additional patient-reported outcomes and imaging measures of myofascial tissue metabolism and perfusion.
This study aims to determine whether acupuncture improves clinical outcomes in patients with myofascial pain syndrome and to evaluate TB-PET/CT as an objective imaging biomarker of myofascial tissue dysfunction and treatment response. The results may support the development of imaging-based tools for evaluating chronic musculoskeletal pain and monitoring treatment effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Procedure: Acupuncture, Procedure: Total-Body PET/CT ImagingParticipants randomized to the experimental arm will receive standardized acupuncture treatment up to three sessions per week for eight weeks (maximum of 24 sessions) administered by a licensed acupuncturist. |
| Sham Acupuncture | Sham comparator | Procedure: Sham Acupuncture, Procedure: Total-Body PET/CT ImagingParticipants randomized to the control arm will receive sham acupuncture using non-penetrating needles designed to mimic acupuncture procedures without therapeutic needle penetration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand the purposes and risks of the trial and willingness to sign an informed consent form
- Willingness and ability to comply with all protocol required procedures
- Willingness to be randomized to receive either true acupuncture or sham acupuncture
- Current self-report of chronic low back pain (cLBP) which has persisted for the past 3 months AND has resulted in pain on > 50% of days in the past 6 months
- At least one palpable nodule or taut band in paraspinal, quadratus lumborum, or gluteal muscles
Key exclusion criteria (20 listed)
- No Primary Care Physician
- History of spine infection (discitis or osteomyelitis) or spine tumor
- History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus
- Confounding conditions that are known to be responsible for inducing pain
- Implants at or in the region of the sites of interest
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 |
|---|---|---|
| AcupunctureParticipants assigned to the acupuncture group will receive standardized acupuncture treatments administered by a licensed acupuncturist. Treatments will occur up to three times per week for eight weeks (maximum of 24 sessions). | Procedure or surgery | Acupuncture |
| Sham AcupunctureParticipants assigned to the sham control group will receive sham acupuncture using non-penetrating placebo needles designed to mimic the appearance and sensation of acupuncture without skin penetration. Sessions will occur up to three times per week for eight weeks (maximum of 24 sessions) and will follow procedures similar in duration and setting to the acupuncture intervention. | Procedure or surgery | Sham Acupuncture |
| Total-Body PET/CT ImagingParticipants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging using 18F-fluorodeoxyglucose (18F-FDG). Imaging will be performed at baseline (prior to the first acupuncture/sham acupuncture) and at 8 weeks (after the last acupuncture/sham acupuncture session), with an optional mid-treatment scan at 4 weeks, to evaluate metabolic activity and perfusion in myofascial tissue. | Procedure or surgery | Acupuncture, Sham Acupuncture |
Primary outcome
Change in PEG score from Baseline to 8 weeks
Time frame: Baseline and 8 weeks post-intervention
Change in PEG (Pain intensity, Enjoyment of life, General activity) score from baseline to 8 weeks. The PEG is a 3-item patient-reported outcome measure assessing pain intensity and pain interference with enjoyment of life and general activity. Higher scores indicate worse pain severity and interference. This is the primary clinical endpoint.
Change in Standardized Uptake Values in Myofascial Regions of Interest on TB-PET/CT from Baseline to 8 weeks
Time frame: Baseline and 8 weeks post-intervention
Change in standardized uptake values (SUV) in predefined myofascial regions of interest as measured by total-body positron emission tomography/computed tomography (TB-PET/CT) from baseline to 8 weeks. This is the primary imaging endpoint.
7 secondary outcomes
Percent Change in PET-Derived K1 Perfusion (mL/min/g) Averaged Across Predefined Myofascial Regions of Interest
Time frame: Baseline and 8 weeks post-intervention
Change in PROMIS Sleep Disturbance Short Form 6a T-Score
Time frame: Baseline and 8 weeks post-intervention
Change in Pain Catastrophizing Scale - Short Form 6 Score
Time frame: Baseline and 8 weeks post-intervention
Patient Global Impression of Change at 8 Weeks
Time frame: 8 weeks post-intervention
Change in Patient Health Questionnaire-2 Score
Time frame: Baseline and 8 weeks post-intervention
Change in Generalized Anxiety Disorder-2 Score
Time frame: Baseline and 8 weeks post-intervention
Change in TAPS-1 Score
Time frame: Baseline and 8 weeks post-intervention
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 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Abhijit J Chaudhari, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Total-Body PET/CT Imaging in people with Myofascial Pain Syndrome (MPS) and Chronic Low-back Pain (cLBP), run by University of California, Davis at 1 site in United States.
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 11 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 17 Jun 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 United States. 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. Some participants in this study may receive a placebo. 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 Clinical Research Coordinator Team (916-731-9004, research-radiology-som@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PEG score from Baseline to 8 weeks (time frame: Baseline and 8 weeks post-intervention). The study lists 2 primary outcomes in all. 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 17 Jun 2026.