Myofascial Pain SyndromeNCT04998630
Comparison of Focused ESWT by Frequency for Patients With Myofascial Pain Syndrome
A study testing Extracorporeal shockwave therapy in people with Myofascial Pain Syndrome, run by CHA University at 1 site in South Korea.
Trial summary
To investigate the efficacy and safety according to the frequency of focused ESWT in patients with myofascial pain syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jun 2021to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those diagnosed with myofascial pain syndrome according to Simon's criteria
- Pain is 4 points or more on the Numerical Rating Scale (NRS)
Who cannot join
- Pain is due to trauma, fibromyalgia and neurological disorders including neuromyopathy, myelopathy, and stroke
- If you have received injection treatment for trigger points within the last 2 months or have had surgery on the painful area within 1 year
- If there is a high risk of bleeding due to severe coagulopathy, etc. or if you have recently had severe bleeding (except taking antiplatelet)
- If you have a tumor, infection, kidney failure, severe liver disease, epilepsy, skin disease, or mental retardation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Bundang CHA Medical Center
Seongnam-si, Gyeonggi-do, 13496
Kyunghoon Min, MD, PhD, 82-31-780-1892, minkhrm@gmail.com
About this study
Official title: Comparison of Focused ESWT by Low and High Frequency for Patients With Myofascial Pain Syndrome: a Pilot Study
To investigate the efficacy and safety according to the frequency of focused ESWT in patients with myofascial pain syndrome.
Read the detailed description
Myofascial pain syndrome is one of the common causes of musculoskeletal pain seen in clinical practice and is characterized by the presence of trigger points associated with sensitive areas such as taut bands of skeletal muscle. It may also be accompanied by referred pain, which is pain in other parts of the body. Although the pathophysiology and etiology of myofascial pain syndrome and trigger points are still unknown, there are reports that myofascial pain is a complex form of neuromuscular dysfunction caused by motor and sensory abnormalities involving both the peripheral nervous system and the central nervous system. Recently, it has been considered as a method of treatment for myofascial pain syndrome. In addition, although pain reduction and functional improvement of focused ESWT in patients with myofascial pain syndrome have been reported, related studies are lacking on the effect of focused ESWT according to the frequency difference. The purpose of the study is to examine the efficacy and safety of focused type ESWT frequency in patients with myofascial pain syndrome.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Extracorporeal shockwave therapy
- Keywords
- ESWT, myofascial pain syndrome
- 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.
Extracorporeal shockwave therapyDevice
Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08~0.28 mJ/m2) the degree to which the subject can tolerate
| Study group | Role | What they receive |
|---|---|---|
| A (4Hz) | Experimental | ESWT frequency 4Hz washout period: 1 week Receives: Device: Extracorporeal shockwave therapy |
| B (8Hz) | Experimental | ESWT frequency 8Hz washout period: 1 week Receives: Device: Extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline NRS (numerical rating scale) at each time frame
Pain intensity (0-10, ordinal scale)
Measured: baseline, immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment
Secondary outcomes (1)
Number of treatment-related adverse events as assessed by CTCAE v4.0 at each time frame
Common Terminology Criteria for Adverse Events
Measured: immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start22 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyunghoon Min, MD, PhD, Study director, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998630
- Sponsor's protocol ID
- 2021-05-029
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 10 Aug 2021
- 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 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Focused ESWT by Low and High Frequency for Patients With Myofascial Pain Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT04998630
- Acronym / sponsor ID
- 2021-05-029
- Conditions
- Myofascial Pain Syndrome
- Keywords
- ESWT, myofascial pain syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Aug 2021 (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.
To investigate the efficacy and safety according to the frequency of focused ESWT in patients with myofascial pain syndrome.
Detailed description
Myofascial pain syndrome is one of the common causes of musculoskeletal pain seen in clinical practice and is characterized by the presence of trigger points associated with sensitive areas such as taut bands of skeletal muscle. It may also be accompanied by referred pain, which is pain in other parts of the body. Although the pathophysiology and etiology of myofascial pain syndrome and trigger points are still unknown, there are reports that myofascial pain is a complex form of neuromuscular dysfunction caused by motor and sensory abnormalities involving both the peripheral nervous system and the central nervous system. Recently, it has been considered as a method of treatment for myofascial pain syndrome. In addition, although pain reduction and functional improvement of focused ESWT in patients with myofascial pain syndrome have been reported, related studies are lacking on the effect of focused ESWT according to the frequency difference. The purpose of the study is to examine the efficacy and safety of focused type ESWT frequency in patients with myofascial pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (4Hz) | Experimental | Device: Extracorporeal shockwave therapyESWT frequency 4Hz washout period: 1 week |
| B (8Hz) | Experimental | Device: Extracorporeal shockwave therapyESWT frequency 8Hz washout period: 1 week |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those diagnosed with myofascial pain syndrome according to Simon's criteria
- Pain is 4 points or more on the Numerical Rating Scale (NRS)
Key exclusion criteria (4 listed)
- Pain is due to trauma, fibromyalgia and neurological disorders including neuromyopathy, myelopathy, and stroke
- If you have received injection treatment for trigger points within the last 2 months or have had surgery on the painful area within 1 year
- If there is a high risk of bleeding due to severe coagulopathy, etc. or if you have recently had severe bleeding (except taking antiplatelet)
- If you have a tumor, infection, kidney failure, severe liver disease, epilepsy, skin disease, or mental retardation
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 |
|---|---|---|
| Extracorporeal shockwave therapyTreatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08~0.28 mJ/m2) the degree to which the subject can tolerate | Device | A (4Hz), B (8Hz) |
Primary outcome
Change from baseline NRS (numerical rating scale) at each time frame
Time frame: baseline, immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment
Pain intensity (0-10, ordinal scale)
1 secondary outcome
Number of treatment-related adverse events as assessed by CTCAE v4.0 at each time frame
Time frame: immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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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.
Kyunghoon Min, MD, PhD study director
Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave therapy in people with Myofascial Pain Syndrome, run by CHA University at 1 site in South Korea.
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 2 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 10 Aug 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyunghoon Min, MD, PhD (82-31-780-1892, minkhrm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline NRS (numerical rating scale) at each time frame (time frame: baseline, immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment). 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 10 Aug 2021.