Myofascial Pain SyndromeNCT03436459
Effects of Extracorporeal Shock Wave Therapy and Low Level Laser Therapy in Myofascial Pain Syndrome
A study testing Extracorporeal Shock Wave Therapy and Low Level Laser Therapy in people with Myofascial Pain Syndrome, run by Petz Aladar County Teaching Hospital at 1 site in Hungary.
Trial summary
This study evaluates the effects of low level laser therapy and extracorporeal shock wave therapy in patients with myofascial pain syndrome of the upper trapezius. Half of the patients receive laser therapy, half of them receive shock wave therapy for three weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Extracorporeal Shock Wave Therapy and Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- Feb 2016to Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age with myofascial pain syndrome meeting the Simon's diagnostic criteria (5 major and 1 minor) for at least 8 weeks (chronic pain)
- no physiotherapy or local injection within 3 months before starting the study
Who cannot join
- acute onset of neck pain
- physiotherapy or local injection within 3 months before starting the study
- abnormal lab test (ESR, hematology)
- infection, fever
- cervical radiculopathy
- uncontrolled hypertension, anticoagulation or defect in blood coagulation
- previous cervical operaton
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Shock Wave Therapy and Low Level Laser Therapy Effect in Patients With Myofascial Pain Syndrome of the Trapezius
This study evaluates the effects of low level laser therapy and extracorporeal shock wave therapy in patients with myofascial pain syndrome of the upper trapezius. Half of the patients receive laser therapy, half of them receive shock wave therapy for three weeks.
Read the detailed description
Low Level Laser Therapy (LLLT) inducing photochemical and photothermal effect, increases blood flow and vascular permeability and improves cell metabolism. All these lead to muscle recovery. It also activates somatosensory receptors of the skin and reduces local pain and muscle spasm.
The specific mechanisms of extracorporeal shock wave therapy (ESWT) in treating musculoskeletal pain remain unclear. It reduces pain and inflammation by modulating nitrogen-monoxide (NO) and vascular endothelial growth factor (VEGF). It can destroy sensory unmyelinated nerve fibers, and stimulate neovascularization and collagen synthesis in degenerative tissues.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Extracorporeal Shock Wave Therapy, Low Level Laser Therapy
- Keywords
- extracorporeal shock wave therapy (ESWT), Low level laser therapy (LLLT), 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 Shock Wave TherapyDevice
shock wave therapy once a week for three weeks, total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute using a BTL-6000 SWT Topline Power® device
Low Level Laser TherapyDevice
LLLT once a day for three weeks (altogether 15 working days) using a PR999 4W scanning laser device; around trigger points with 3 J/cm2, power 800 mW, frequency 2000Hz, on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave therapy group | Active comparator | Patients in the shock wave therapy group received total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute by using BTL-6000 SWT Topline Power® 3 times with a week's interval between the treatments. Receives: Device: Extracorporeal Shock Wave Therapy |
| Low Level Laser Therapy group | Active comparator | Patients in the laser therapy group received LLLT once a day for three weeks (altogether 15 working days) to the trigger points and around them in the upper trapezius. The type of laser used: PR999 4 Watt (W) scanning laser; Medical Italia®, around trigger points with 3 Joule /centimeter² (J/cm²), power 800 milliwatt (mW), frequency 2000 Hertz (Hz), on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot. Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in severity of pain at rest
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
Measured: week 0 and week
change in severity of pain at rest
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
Measured: week 0 and week 15
change in severity of pressure pain
change from baseline severity of pressure pain recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
Measured: week 0 and week 3
change in severity of pressure pain
change from baseline severity of pressure pain recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
Measured: week 0 and week 15
change in function (percentage of disability)
change from baseline Neck Disability Index (NDI) at week 3. It includes 10 part; pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping and entertainments. There are six presumptions; the first is given 0 and the last presumption has the score of 5. The total maximum score is 50, that represents 100% disability. The lower score represents better outcome.
Measured: week 0 and week 3
change in function (percentage of disability)
change from baseline Neck Disability Index (NDI) at week 15. It includes 10 part; pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping and entertainments. There are six presumptions; the first is given 0 and the last presumption has the score of 5. The total maximum score is 50, that represents 100% disability. The lower score represents better outcome.
Measured: week 0 and week 15
change in quality of life
change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 3. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
Measured: week 0 and week 3
change in quality of life
change from baseline quality of life (SF-36) at week 15. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
Measured: week 0 and week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startFeb 2016
- Primary completionFeb 2017
- Study completionSep 2017
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petz Aladar County Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Márta Király, Petz Aladar County Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436459
- Sponsor's protocol ID
- PetzAladarCTH
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kiraly M, Bender T, Hodosi K. Comparative study of shockwave therapy and low-level laser therapy effects in patients with myofascial pain syndrome of the trapezius. Rheumatol Int. 2018 Nov;38(11):2045-2052. doi: 10.1007/s00296-018-4134-x. Epub 2018 Aug 31.
PubMed 30171341
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Shock Wave Therapy and Low Level Laser Therapy Effect in Patients With Myofascial Pain Syndrome of the Trapezius
- ClinicalTrials.gov ID
- NCT03436459
- Acronym / sponsor ID
- PetzAladarCTH
- Conditions
- Myofascial Pain Syndrome
- Keywords
- extracorporeal shock wave therapy (ESWT), Low level laser therapy (LLLT), Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Petz Aladar County Teaching HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Feb 2018 (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 evaluates the effects of low level laser therapy and extracorporeal shock wave therapy in patients with myofascial pain syndrome of the upper trapezius. Half of the patients receive laser therapy, half of them receive shock wave therapy for three weeks.
Detailed description
Low Level Laser Therapy (LLLT) inducing photochemical and photothermal effect, increases blood flow and vascular permeability and improves cell metabolism. All these lead to muscle recovery. It also activates somatosensory receptors of the skin and reduces local pain and muscle spasm.
The specific mechanisms of extracorporeal shock wave therapy (ESWT) in treating musculoskeletal pain remain unclear. It reduces pain and inflammation by modulating nitrogen-monoxide (NO) and vascular endothelial growth factor (VEGF). It can destroy sensory unmyelinated nerve fibers, and stimulate neovascularization and collagen synthesis in degenerative tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy group | Active comparator | Device: Extracorporeal Shock Wave TherapyPatients in the shock wave therapy group received total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute by using BTL-6000 SWT Topline Power® 3 times with a week's interval between the treatments. |
| Low Level Laser Therapy group | Active comparator | Device: Low Level Laser TherapyPatients in the laser therapy group received LLLT once a day for three weeks (altogether 15 working days) to the trigger points and around them in the upper trapezius. The type of laser used: PR999 4 Watt (W) scanning laser; Medical Italia®, around trigger points with 3 Joule /centimeter² (J/cm²), power 800 milliwatt (mW), frequency 2000 Hertz (Hz), on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years of age with myofascial pain syndrome meeting the Simon's diagnostic criteria (5 major and 1 minor) for at least 8 weeks (chronic pain)
- no physiotherapy or local injection within 3 months before starting the study
Key exclusion criteria (7 listed)
- acute onset of neck pain
- physiotherapy or local injection within 3 months before starting the study
- abnormal lab test (ESR, hematology)
- infection, fever
- cervical radiculopathy
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 Shock Wave Therapyshock wave therapy once a week for three weeks, total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute using a BTL-6000 SWT Topline Power® device | Device | Extracorporeal shock wave therapy group |
| Low Level Laser TherapyLLLT once a day for three weeks (altogether 15 working days) using a PR999 4W scanning laser device; around trigger points with 3 J/cm2, power 800 mW, frequency 2000Hz, on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot | Device | Low Level Laser Therapy group |
Primary outcome
change in severity of pain at rest
Time frame: week 0 and week
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in severity of pain at rest
Time frame: week 0 and week 15
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in severity of pressure pain
Time frame: week 0 and week 3
change from baseline severity of pressure pain recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in severity of pressure pain
Time frame: week 0 and week 15
change from baseline severity of pressure pain recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in function (percentage of disability)
Time frame: week 0 and week 3
change from baseline Neck Disability Index (NDI) at week 3. It includes 10 part; pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping and entertainments. There are six presumptions; the first is given 0 and the last presumption has the score of 5. The total maximum score is 50, that represents 100% disability. The lower score represents better outcome.
change in function (percentage of disability)
Time frame: week 0 and week 15
change from baseline Neck Disability Index (NDI) at week 15. It includes 10 part; pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping and entertainments. There are six presumptions; the first is given 0 and the last presumption has the score of 5. The total maximum score is 50, that represents 100% disability. The lower score represents better outcome.
change in quality of life
Time frame: week 0 and week 3
change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 3. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
change in quality of life
Time frame: week 0 and week 15
change from baseline quality of life (SF-36) at week 15. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
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 20 Feb 2018.
- Derived from this study: PubMed 30171341Kiraly M, Bender T, Hodosi K. Comparative study of shockwave therapy and low-level laser therapy effects in patients with myofascial pain syndrome of the trapezius. Rheumatol Int. 2018 Nov;38(11):2045-2052. doi: 10.1007/s00296-018-4134-x. Epub 2018 Aug 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shock Wave Therapy and Low Level Laser Therapy in people with Myofascial Pain Syndrome, run by Petz Aladar County Teaching Hospital at 1 site in Hungary.
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 7 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 20 Feb 2018. 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 Hungary. 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?
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?
change in severity of pain at rest (time frame: week 0 and week). The study lists 8 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 NCT03436459, 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 20 Feb 2018.