Myofascial Pain SyndromesNCT01835795
Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
A study testing Swiss DolorClast® CLASSIC applicator in people with Myofascial Pain Syndromes and Low Back Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and imaging exams. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndromes, Low Back Pain, Lumbago
- What is being tested?
- Swiss DolorClast® CLASSIC applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jan 2013to 18 Jan 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presenting clinical complaints of lumbar and / or gluteal pains for 3 months or more
- Display pain of moderate to severe intensity: visual analogue scale (VAS)> 4
- Diagnosis of myofascial pain syndrome in the lumbar and / or gluteal
- Authorize in writing the term of free and informed consent to participate in the study
- Availability of frequent attendance at hospital
Who cannot join
- Organic or psychological disorders that contraindication participation of patients in study
- Metabolic, infectious, oncological or rheumatologic disorders
- Fibromyalgia
- Labor dispute
- Indication for surgery in column
- Contraindications to therapy of shock waves:
Show all 16Show fewer
- Coagulopathy and / or anticoagulant
- Pregnancy
- Acute infection in soft tissue or bone
- Systemic Infections
- Presence of ulcers at treatment sites
- Presence of larger vessels or nerves at treatment sites
- Polyneuropathies
- Malignancies
- Cardiac arrhythmias or use of pacemaker
- Epilepsy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-010
About this study
Official title: Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and imaging exams.
Read the detailed description
BACKGROUND: Extracorporeal shockwave treatment has been used widely for musculoskeletal conditions, however no randomized controlled trial are available about its use for chronic low back pain with myofascial pain syndrome (MPS).
HYPOTHESIS: Radial extracorporeal shockwave treatment (rESWT) improves pain intensity and functional disability compared with placebo in patients with chronic low back pain due to MPS.
STUDY DESIGN: Randomized controlled clinical trial METHODS: A prospective, randomized, double-blind, placebo-controlled study will be carried out on 40 patients who has moderate to severe pain (VAS > 4) for more than 6 months, despite 6 weeks of conservative treatment with antidepressants associated with rehabilitation. Six interventions of rESWT (3-4 bar; 1000 impulses per trigger point (TP) or 2500 impulses per muscle) will be compared with placebo. The outcome measures were pain visual analogue scale (VAS), Oswestry Disability Index, Short-form McGill Pain Questionnaire, Roland Morris Disability Questionnaire and the temperature of the treated area will be evaluated with Thermography. The assessments will be apply before treatment, after conservative treatment, 6 and 12 weeks after rESWT.
- Conditions
- Myofascial Pain Syndromes, Low Back Pain, Lumbago
- Being tested
- Swiss DolorClast® CLASSIC applicator, Swiss DolorClast® CLASSIC placebo applicator
- Keywords
- Myofascial Pain Syndromes, Myofascial Trigger Point, Low Back Pain, Lumbago, Shock Waves, High-Energy, High-Energy Shock Waves, Interdisciplinary Health Team, Multidisciplinary Pain Centers
- Medical subject headings
- Myofascial Pain Syndromes, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swiss DolorClast® CLASSIC applicatorDevice
Radial Extracorporeal Shock Wave applicator use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure
Swiss DolorClast® CLASSIC placebo applicatorDevice
Placebo applicator, use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure
| Study group | Role | What they receive |
|---|---|---|
| Radial Extracorporeal Shock Wave | Active comparator | Swiss DolorClast® CLASSIC applicator Receives: Device: Swiss DolorClast® CLASSIC applicator |
| Placebo | Placebo comparator | Swiss DolorClast® CLASSIC placebo applicator Receives: Device: Swiss DolorClast® CLASSIC placebo applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of pain relief by visual analogue scale (VAS) of radial extracorporeal shock waves in myofascial pain syndrome in the lumbar and gluteal region compared to placebo
The outcome will be assessed by Visual Analogue Scale (VAS)
Measured: 12 weeks after the last session of shockwave
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study start7 Jan 2013
- Primary completion19 Mar 2018
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Kobayashi, University of Sao Paulo
- Investigators
- Ricardo Kobayashi, Principal investigator, IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835795
- Sponsor's protocol ID
- CAAE 06251612.7.0000.0068
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2013
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
- ClinicalTrials.gov ID
- NCT01835795
- Acronym / sponsor ID
- CAAE 06251612.7.0000.0068
- Conditions
- Myofascial Pain Syndromes, Low Back Pain, Lumbago
- Keywords
- Myofascial Pain Syndromes, Myofascial Trigger Point, Low Back Pain, Lumbago, Shock Waves, High-Energy, High-Energy Shock Waves, Interdisciplinary Health Team, Multidisciplinary Pain Centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 19 Apr 2013 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and imaging exams.
Detailed description
BACKGROUND: Extracorporeal shockwave treatment has been used widely for musculoskeletal conditions, however no randomized controlled trial are available about its use for chronic low back pain with myofascial pain syndrome (MPS).
HYPOTHESIS: Radial extracorporeal shockwave treatment (rESWT) improves pain intensity and functional disability compared with placebo in patients with chronic low back pain due to MPS.
STUDY DESIGN: Randomized controlled clinical trial METHODS: A prospective, randomized, double-blind, placebo-controlled study will be carried out on 40 patients who has moderate to severe pain (VAS > 4) for more than 6 months, despite 6 weeks of conservative treatment with antidepressants associated with rehabilitation. Six interventions of rESWT (3-4 bar; 1000 impulses per trigger point (TP) or 2500 impulses per muscle) will be compared with placebo. The outcome measures were pain visual analogue scale (VAS), Oswestry Disability Index, Short-form McGill Pain Questionnaire, Roland Morris Disability Questionnaire and the temperature of the treated area will be evaluated with Thermography. The assessments will be apply before treatment, after conservative treatment, 6 and 12 weeks after rESWT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Extracorporeal Shock Wave | Active comparator | Device: Swiss DolorClast® CLASSIC applicatorSwiss DolorClast® CLASSIC applicator |
| Placebo | Placebo comparator | Device: Swiss DolorClast® CLASSIC placebo applicatorSwiss DolorClast® CLASSIC placebo applicator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presenting clinical complaints of lumbar and / or gluteal pains for 3 months or more
- Display pain of moderate to severe intensity: visual analogue scale (VAS)> 4
- Diagnosis of myofascial pain syndrome in the lumbar and / or gluteal
- Authorize in writing the term of free and informed consent to participate in the study
- Availability of frequent attendance at hospital
Key exclusion criteria (16 listed)
- Organic or psychological disorders that contraindication participation of patients in study
- Metabolic, infectious, oncological or rheumatologic disorders
- Fibromyalgia
- Labor dispute
- Indication for surgery in column
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 |
|---|---|---|
| Swiss DolorClast® CLASSIC applicatorRadial Extracorporeal Shock Wave applicator use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure | Device | Radial Extracorporeal Shock Wave |
| Swiss DolorClast® CLASSIC placebo applicatorPlacebo applicator, use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure | Device | Placebo |
Primary outcome
Evidence of pain relief by visual analogue scale (VAS) of radial extracorporeal shock waves in myofascial pain syndrome in the lumbar and gluteal region compared to placebo
Time frame: 12 weeks after the last session of shockwave
The outcome will be assessed by Visual Analogue Scale (VAS)
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 30 Apr 2019.
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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.
Ricardo Kobayashi principal investigator
IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swiss DolorClast® CLASSIC applicator in people with Myofascial Pain Syndromes and Low Back Pain, run by University of Sao Paulo at 1 site in Brazil.
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 16 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 30 Apr 2019. 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 Brazil. 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?
Evidence of pain relief by visual analogue scale (VAS) of radial extracorporeal shock waves in myofascial pain syndrome in the lumbar and gluteal region compared to placebo (time frame: 12 weeks after the last session of shockwave). 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 30 Apr 2019.