FibromyalgiaSWPW-FPSNCT03088215
Shock-Waves to Treat Fibromyalgia Pain
A study testing shock-waves in people with Fibromyalgia and Myofascial Pain Syndrome, run by Dr Yves JACOT, MD.
Trial summary
Fibromyalgia pain syndrome is a common debilitating condition which associates mainly generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no specific treatment exists so far. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Myofascial Pain Syndrome, MSK: Chronic Pain Syndromes (E.G. Fibromyalgia)
- What is being tested?
- shock-waves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2017to 20 Nov 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American College of Rheumatology 2011 diagnostic criteria for Fibromyalgia met
- Aged between 18 and 65 years
- Informed Consent Form signed
Who cannot join
- Known skeletal pathologies such as osteoarthritis of major joints and / or vertebrae, inflammatory states involving bones, joints, tendons or muscles, or previous heavy trauma directly causing the pain
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, carcinoma, cardiovascular disease, pulmonary insufficiency, etc.),
- Coagulopathies, anticoagulant or corticosteroid based medication, thrombosis.
- Psychological distress, psychosis, dementia
- Known or suspected non-compliance, drug or alcohol abuse,
- Pregnancy
- Enrolment of the investigator, his/her family members, employees and other dependent or vulnerable persons
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study
Fibromyalgia pain syndrome is a common debilitating condition which associates mainly generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no specific treatment exists so far.
Lately, shock-waves have been used successfully to treat painful skeletal muscle, tendons and fascia, the investigators therefore hypothesize that shock-waves could be useful in alleviating Fibromyalgia pain.
Read more
Two similar groups of participants bearing the condition will be prospectively compared.
The first group will benefit from the application of shock-waves weekly for 12 weeks, the second will not.
The investigators intend to study if there is any difference in pain and quality of life between the two groups at the end of the three months.
Read the detailed description
Fibromyalgia Pain Syndrome (FPS) is a common debilitating condition which associates mainly generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no specific treatment exists so far.
It bears some similarities with another, more localised clinical condition : the Myofascial Pain Syndrome (MPS), which results in pain caused by, amongst others, muscular trigger points.
Lately, FPS and MPS have both been classified as belonging to a new, larger entity : Central Sensitivity Syndromes (CSS), in which a strong and chronic peripheral sensitive stimulus (like musculoskeletal pain) is believed to induce, after some time, an enhanced response of the central nervous system (CNS) towards that same stimulus, with the result that the stimulus will be felt more powerfully (central sensitization, CS). This is secondary to neuroplastic changes in the CNS, which are reversible to some extent.
Since shock-waves are effective to treat pain in MPS (by eliminating trigger points and thus restoring muscle and tissue function), and since MPS and FPS could be linked by a common pathophysiologic mechanism (CSS), the investigators hypothesize that shock waves could be beneficial in treating pain in FPS.
Two groups of 20 participants will be prospectively compared over a three month's period.
One group will receive shock-waves on painful muscular areas weekly for 12 weeks, the other group will not receive any shock-waves.
The investigators intend to study if there is any difference in pain and quality of life after the end of the three months.
- Conditions
- Fibromyalgia, Myofascial Pain Syndrome, MSK: Chronic Pain Syndromes (E.G. Fibromyalgia), Central Sensitization
- Being tested
- shock-waves
- Keywords
- Trigger Point Pain, Myofascial, shock-waves, extracorporeal shock-wave treatment (ESWT), pain, trigger point, referred pain
- Medical subject headings
- Fibromyalgia, Myofascial Pain Syndromes, Pain, Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock-wavesDevice
Application of shock-waves (radial and focused)
| Study group | Role | What they receive |
|---|---|---|
| A / Shock-waves | Experimental | Will receive shock-waves Receives: Device: shock-waves |
| B / Nothing | No intervention | Will not receive shock-waves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS
Horizontal visual analog scale for pain (pain intensity)
Measured: 12 weeks
Secondary outcomes (3)
Apparent change in successive Pain Body Maps over time
Participants will be distributed successive body map models where they are asked to draw the precise location and extension of the areas where they experience pain.
The maps completed at every given time will then be compiled for each group (by computer).
The final compiled pictures will be visually compared between each group. So far, it is not planned to do measurements (such as surface, etc...), the maps will serve mainly illustrate differences in pain extension between the two groups.
Measured: 12 weeks
Interference scale of the Body Pain Index (BPI)
Questionnaire reflecting interference of pain in quality of life
Measured: 12 weeks
Patient Global Impression of Change scale (PGIC)
Questionnaire reflecting effects of intervention (or non-intervention)from the participant's point of view
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start20 Oct 2017 (estimated)
- Primary completion20 Nov 2018 (estimated)
- Study completion20 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Yves JACOT, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Projet Suisse d'Assistance Medicale
- Responsible party
- Sponsor-investigator, Dr Yves JACOT, MD, Projet Suisse d'Assistance Medicale
- Investigators
- Dr Yves JACOT, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088215
- Sponsor's protocol ID
- SWPW-FPS - v1.0 - 07/03/2017
- Acronym
- SWPW-FPS
- Status last verified
- Oct 2017
- First submitted
- 10 Mar 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study
- ClinicalTrials.gov ID
- NCT03088215
- Acronym / sponsor ID
- SWPW-FPS / SWPW-FPS - v1.0 - 07/03/2017
- Conditions
- Fibromyalgia, Myofascial Pain Syndrome, MSK: Chronic Pain Syndromes (E.G. Fibromyalgia), Central Sensitization
- Keywords
- Trigger Point Pain, Myofascial, shock-waves, extracorporeal shock-wave treatment (ESWT), pain, trigger point, referred pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr Yves JACOT, MDUniversity, hospital or other
- Collaborators
- Projet Suisse d'Assistance Medicale
- Study start
- 20 Oct 2017 (estimated)
- Primary completion
- 20 Nov 2018 (estimated)
- Study completion
- 20 Nov 2018 (estimated)
- First posted
- 23 Mar 2017 (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.
Fibromyalgia pain syndrome is a common debilitating condition which associates mainly generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no specific treatment exists so far.
Lately, shock-waves have been used successfully to treat painful skeletal muscle, tendons and fascia, the investigators therefore hypothesize that shock-waves could be useful in alleviating Fibromyalgia pain.
Two similar groups of participants bearing the condition will be prospectively compared.
The first group will benefit from the application of shock-waves weekly for 12 weeks, the second will not.
The investigators intend to study if there is any difference in pain and quality of life between the two groups at the end of the three months.
Detailed description
Fibromyalgia Pain Syndrome (FPS) is a common debilitating condition which associates mainly generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no specific treatment exists so far.
It bears some similarities with another, more localised clinical condition : the Myofascial Pain Syndrome (MPS), which results in pain caused by, amongst others, muscular trigger points.
Lately, FPS and MPS have both been classified as belonging to a new, larger entity : Central Sensitivity Syndromes (CSS), in which a strong and chronic peripheral sensitive stimulus (like musculoskeletal pain) is believed to induce, after some time, an enhanced response of the central nervous system (CNS) towards that same stimulus, with the result that the stimulus will be felt more powerfully (central sensitization, CS). This is secondary to neuroplastic changes in the CNS, which are reversible to some extent.
Since shock-waves are effective to treat pain in MPS (by eliminating trigger points and thus restoring muscle and tissue function), and since MPS and FPS could be linked by a common pathophysiologic mechanism (CSS), the investigators hypothesize that shock waves could be beneficial in treating pain in FPS.
Two groups of 20 participants will be prospectively compared over a three month's period.
One group will receive shock-waves on painful muscular areas weekly for 12 weeks, the other group will not receive any shock-waves.
The investigators intend to study if there is any difference in pain and quality of life after the end of the three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A / Shock-waves | Experimental | Device: shock-wavesWill receive shock-waves |
| B / Nothing | No intervention | –Will not receive shock-waves |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American College of Rheumatology 2011 diagnostic criteria for Fibromyalgia met
- Aged between 18 and 65 years
- Informed Consent Form signed
Key exclusion criteria (7 listed)
- Known skeletal pathologies such as osteoarthritis of major joints and / or vertebrae, inflammatory states involving bones, joints, tendons or muscles, or previous heavy trauma directly causing the pain
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, carcinoma, cardiovascular disease, pulmonary insufficiency, etc.),
- Coagulopathies, anticoagulant or corticosteroid based medication, thrombosis.
- Psychological distress, psychosis, dementia
- Known or suspected non-compliance, drug or alcohol abuse,
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 |
|---|---|---|
| shock-wavesApplication of shock-waves (radial and focused) | Device | A / Shock-waves |
Primary outcome
Pain VAS
Time frame: 12 weeks
Horizontal visual analog scale for pain (pain intensity)
3 secondary outcomes
Apparent change in successive Pain Body Maps over time
Time frame: 12 weeks
Interference scale of the Body Pain Index (BPI)
Time frame: 12 weeks
Patient Global Impression of Change scale (PGIC)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- 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.
Dr Yves JACOT, MD study director
Questions about this trial
What is this clinical trial studying?
A study testing shock-waves in people with Fibromyalgia and Myofascial Pain Syndrome, run by Dr Yves JACOT, MD.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Oct 2017. 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 Dr Yves JACOT, MD (004179 703 24 72, yves.jacot@cmvesenaz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS (time frame: 12 weeks). 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 9 Oct 2017.