Clinical trial NCT03088215: Shock-Waves to Treat Fibromyalgia Pain
Official title: Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Projet Suisse d'Assistance Medicale
Sponsor class: OTHER
Collaborators: name: Projet Suisse d'Assistance Medicale
First posted: 2017-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* American College of Rheumatology 2011 diagnostic criteria for Fibromyalgia met
* Aged between 18 and 65 years
* Informed Consent Form signed

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain VAS
timeFrame: 12 weeks
Secondary outcomes:
measure: Apparent change in successive Pain Body Maps over time
timeFrame: 12 weeks
measure: Interference scale of the Body Pain Index (BPI)
timeFrame: 12 weeks
measure: Patient Global Impression of Change scale (PGIC)
timeFrame: 12 weeks
Other outcomes:
measure: American College of Rheumatology (ACR) diagnostic criteria 2011 for Fibromyalgia
timeFrame: 12 weeks
Locations:
Study officials:
name: Dr Yves JACOT, MD
role: STUDY_DIRECTOR
References: