Myofascial Pain SyndromeNCT03867604
Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle
A study testing Fascia injection in people with Myofascial Pain Syndrome, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Patients with myofascial pain syndrome at upper trapezius will be randomized into 2 groups, fascial injection group and subcutaneous control injection group. Pain condition pain, range of motion and function will be evaluated in 1 week, 4 weeks and 12 weeks after injection. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Fascia injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2019to 1 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-70 years old
- diagnosed as a myofascial pain syndrome at upper trapezium muscle
- trigger point
- taut band
- refer pain while taut band irritation
Who cannot join
- Cognitive impairment.
- Post operation at neck and shoulder.
- Nerve compression at cervical region.
- Could not receive injection therapy, history of fainting during needling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle: A Pilot Study
Patients with myofascial pain syndrome at upper trapezius will be randomized into 2 groups, fascial injection group and subcutaneous control injection group. Pain condition pain, range of motion and function will be evaluated in 1 week, 4 weeks and 12 weeks after injection.
Read the detailed description
Myofascial pain syndrome(MPS) is characterized by a trigger point with a hyperirritable nodule and taut band of muscle or fascia. MPS was usually treated by dry needling or met needing, local anesthetics injection, to the trigger point. According to recent researches, dry and wet needling to affected muscle are effectiveness for short term and medium term pain relief. Although some researches indicated an increased viscosity at fascial layer in MPS and there are few studies of manipulation for fascial release. There is not study of injective fascial release.
Investigators will include 40 patients with myofascial pain syndrome at upper trapezius. Participants will be randomized into 2 groups, fascia injection group and subcutaneous control injection group. Investigators will use algometer to measure pain threshold and peak pressure, measure the range of motion of neck and shoulder and assess the neck and shoulder function by questionnaire. The examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.
To our hypothesis, investigators suggest focal anesthetics injection could decrease the fascial viscosity and improved pain and quality of life.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Sham injection, Fascia injection
- 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.
Sham injectionProcedure or surgery
Injection to the subcutaneous layer at upper trapezium level
Fascia injectionProcedure or surgery
Injection to the fascia below upper trapezium muscle
| Study group | Role | What they receive |
|---|---|---|
| Sham injection | Sham comparator | Subcutaneous injection at upper trapezium muscle level Receives: Procedure: Sham injection |
| Fascia injection | Experimental | Fascia injection, below upper trapezium muscle Receives: Procedure: Fascia injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper back or shoulder pain
visual analogue scale(VAS), range 0-10, the higher the worse pain
Measured: Change from baseline VAS at 1 week
Upper back or shoulder pain
visual analogue scale(VAS), range 0-10, the higher the worse pain
Measured: Change from baseline VAS at 4 week
Upper back or shoulder pain
visual analogue scale(VAS), range 0-10, the higher the worse pain
Measured: Change from baseline VAS at 12 week
Secondary outcomes (3)
Function
Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
Measured: Change from baseline SPADI at 1 week
Function
Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
Measured: Change from baseline SPADI at 4 week
Function
Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
Measured: Change from baseline SPADI at 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsuan Cheng, Cheng, Study director, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867604
- Sponsor's protocol ID
- N201811013
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hsu CY, Hsu T, Lin YN, Cheng YH. Additional Effect of Interfascial Hydrodissection With Dextrose on Shoulder and Neck Function in Patients With Myofascial Pain Syndrome: A Randomized Control Trial. Am J Phys Med Rehabil. 2024 Sep 1;103(9):827-834. doi: 10.1097/PHM.0000000000002442. Epub 2024 Jan 31.
PubMed 38320240
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle: A Pilot Study
- ClinicalTrials.gov ID
- NCT03867604
- Acronym / sponsor ID
- N201811013
- Conditions
- Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 8 Mar 2019 (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.
Patients with myofascial pain syndrome at upper trapezius will be randomized into 2 groups, fascial injection group and subcutaneous control injection group. Pain condition pain, range of motion and function will be evaluated in 1 week, 4 weeks and 12 weeks after injection.
Detailed description
Myofascial pain syndrome(MPS) is characterized by a trigger point with a hyperirritable nodule and taut band of muscle or fascia. MPS was usually treated by dry needling or met needing, local anesthetics injection, to the trigger point. According to recent researches, dry and wet needling to affected muscle are effectiveness for short term and medium term pain relief. Although some researches indicated an increased viscosity at fascial layer in MPS and there are few studies of manipulation for fascial release. There is not study of injective fascial release.
Investigators will include 40 patients with myofascial pain syndrome at upper trapezius. Participants will be randomized into 2 groups, fascia injection group and subcutaneous control injection group. Investigators will use algometer to measure pain threshold and peak pressure, measure the range of motion of neck and shoulder and assess the neck and shoulder function by questionnaire. The examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.
To our hypothesis, investigators suggest focal anesthetics injection could decrease the fascial viscosity and improved pain and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham injection | Sham comparator | Procedure: Sham injectionSubcutaneous injection at upper trapezium muscle level |
| Fascia injection | Experimental | Procedure: Fascia injectionFascia injection, below upper trapezium muscle |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20-70 years old
- diagnosed as a myofascial pain syndrome at upper trapezium muscle
- trigger point
- taut band
- refer pain while taut band irritation
Key exclusion criteria (4 listed)
- Cognitive impairment.
- Post operation at neck and shoulder.
- Nerve compression at cervical region.
- Could not receive injection therapy, history of fainting during needling
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 |
|---|---|---|
| Sham injectionInjection to the subcutaneous layer at upper trapezium level | Procedure or surgery | Sham injection |
| Fascia injectionInjection to the fascia below upper trapezium muscle | Procedure or surgery | Fascia injection |
Primary outcome
Upper back or shoulder pain
Time frame: Change from baseline VAS at 1 week
visual analogue scale(VAS), range 0-10, the higher the worse pain
Upper back or shoulder pain
Time frame: Change from baseline VAS at 4 week
visual analogue scale(VAS), range 0-10, the higher the worse pain
Upper back or shoulder pain
Time frame: Change from baseline VAS at 12 week
visual analogue scale(VAS), range 0-10, the higher the worse pain
3 secondary outcomes
Function
Time frame: Change from baseline SPADI at 1 week
Function
Time frame: Change from baseline SPADI at 4 week
Function
Time frame: Change from baseline SPADI at 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 38320240Hsu CY, Hsu T, Lin YN, Cheng YH. Additional Effect of Interfascial Hydrodissection With Dextrose on Shoulder and Neck Function in Patients With Myofascial Pain Syndrome: A Randomized Control Trial. Am J Phys Med Rehabil. 2024 Sep 1;103(9):827-834. doi: 10.1097/PHM.0000000000002442. Epub 2024 Jan 31.
- 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. This study is not recruiting at the moment.
Yu-Hsuan Cheng, Cheng study director
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia injection in people with Myofascial Pain Syndrome, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 5 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: finished, as of the sponsor's last update on 13 Mar 2024. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper back or shoulder pain (time frame: Change from baseline VAS at 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867604, which also lists 1 linked publication.
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 13 Mar 2024.