Myofascial Pain SyndromeNCT06379269
Effectiveness Verification of a Smartphone-based System for Assessment and Health Care on Myofascial Pain Syndrome
A study testing App healthcare in people with Myofascial Pain Syndrome, run by China Medical University Hospital.
Trial summary
Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- App healthcare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For those diagnosed with myofascial pain syndrome by a rehabilitation physician, the diagnostic conditions meet the five major signs, including:
- Regional pain,
- Transfer pain,
- Muscle tight band,
- Tender points in the tight band. ,
- Limitation of joint mobility,
Show all 10Show fewer
- And symptoms consistent with any of the items, including:
- Complaints of pain that appear after applying pressure on tender points,
- Local throbbing reaction,
- Pain disappears after injection or after stretching
Who cannot join
- Have any neurological diseases that may cause pain,
- have a history of surgery in the past six months,
- the affected area is in a state of acute inflammation,
- have open wounds, etc.
Trial locations and contacts
No sites are listed yet.
About this study
Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle.With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention.
Read the detailed description
Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle. Common treatments include medications, dry needles, and physical therapy. Among them, physical therapy aims to treat the involved muscle. With the advancement of technology, mHealth (mobile health) has been gradually developed in recent years. With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention.Methods: Feasibility evaluation: Subjects with MPS will be recruited to perform the assessment of the system on their own. And the assessment results for the system will be compared with clinical assessment results done by a rehabilitation physician. The feasibility of the smartphone app will be analyzed through the system usability scale.Health care effects evaluation: Subjects with MPS will be recruited and randomly assigned to the intervention group and control group. The intervention group will receive the smartphone app health care program, and the control group will receive health education. Outcomes will be measured before and after the intervention. The training effects of the app will be evaluated by comparing it with the control group.Expected Results \& Contribution: The smartphone app for identifying the muscle presenting TrPs on MPS subjects is feasible. The healthcare effects of the smartphone app for MPS subjects are effective. Offering an easy-used and effective tool for clinicians and subjects with MPS to evaluate and improve pain and symptoms.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- App healthcare, Control
- Keywords
- myofascial pain syndrome, smartphone
- 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.
App healthcareDevice
Self-developed app: includes home stretching and strengthening exercises, muscle release technique instruction.
ControlOther
general education and home rehab program
| Study group | Role | What they receive |
|---|---|---|
| App group | Experimental | Not described Receives: Device: App healthcare |
| Control group | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
current pain visual analogue scale
pain will be evaluated with visual analogue scale(VAS). 0 means no pain at all;10 means extremely painful.
Measured: 10 minutes
Secondary outcomes (1)
functional questionnaire
corresponding functional questionnaire to the specific body part of the subject. For the neck area, the Neck Disability Index is used. The higher the score, the more disability the patient is. For the lower back area, the Oswestry Disability Index is used. The higher the score, the more disability the patient is. For the upper limb, the Disability of the Arm, Shoulder, and Hand is used. The higher the score, the more severe the patient is. For the lower limb, the Lower Extremity Functional Scale is used. The higher the score, the more sever the patient is.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng Kung University, National Science and Technology Council
- Responsible party
- Principal investigator, Li-Wei Chou, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379269
- Sponsor's protocol ID
- CMUH112-REC3-160
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Verification of a Smartphone-based System for Assessment and Health Care on Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06379269
- Acronym / sponsor ID
- CMUH112-REC3-160
- Conditions
- Myofascial Pain Syndrome
- Keywords
- myofascial pain syndrome, smartphone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Cheng Kung University, National Science and Technology Council
- Study start
- May 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Apr 2024 (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.
Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle.With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention.
Detailed description
Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle. Common treatments include medications, dry needles, and physical therapy. Among them, physical therapy aims to treat the involved muscle. With the advancement of technology, mHealth (mobile health) has been gradually developed in recent years. With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention.Methods: Feasibility evaluation: Subjects with MPS will be recruited to perform the assessment of the system on their own. And the assessment results for the system will be compared with clinical assessment results done by a rehabilitation physician. The feasibility of the smartphone app will be analyzed through the system usability scale.Health care effects evaluation: Subjects with MPS will be recruited and randomly assigned to the intervention group and control group. The intervention group will receive the smartphone app health care program, and the control group will receive health education. Outcomes will be measured before and after the intervention. The training effects of the app will be evaluated by comparing it with the control group.Expected Results \& Contribution: The smartphone app for identifying the muscle presenting TrPs on MPS subjects is feasible. The healthcare effects of the smartphone app for MPS subjects are effective. Offering an easy-used and effective tool for clinicians and subjects with MPS to evaluate and improve pain and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App group | Experimental | Device: App healthcare |
| Control group | Active comparator | Other: Control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For those diagnosed with myofascial pain syndrome by a rehabilitation physician, the diagnostic conditions meet the five major signs, including:
- And symptoms consistent with any of the items, including:
Key exclusion criteria (4 listed)
- Have any neurological diseases that may cause pain,
- have a history of surgery in the past six months,
- the affected area is in a state of acute inflammation,
- have open wounds, etc.
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 |
|---|---|---|
| App healthcareSelf-developed app: includes home stretching and strengthening exercises, muscle release technique instruction. | Device | App group |
| Controlgeneral education and home rehab program | Other | Control group |
Primary outcome
current pain visual analogue scale
Time frame: 10 minutes
pain will be evaluated with visual analogue scale(VAS). 0 means no pain at all;10 means extremely painful.
1 secondary outcome
functional questionnaire
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing App healthcare in people with Myofascial Pain Syndrome, run by China Medical University Hospital.
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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Lan Chiu, Doc (+8866-6-2353535 ext. 6737, yalanchiu@gs.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
current pain visual analogue scale (time frame: 10 minutes). 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 24 Apr 2024.