Clinical Trial: Shock-Waves to Treat Fibromyalgia Pain

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study

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 Summary:

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.

Sponsor: Dr Yves JACOT, MD

Current Primary Outcome: Pain VAS [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Apparent change in successive Pain Body Maps over time [ Time Frame: 12 weeks ]

  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.

• Interference scale of the Body Pain Index (BPI) [ Time Frame: 12 weeks ]
  Questionnaire reflecting interference of pain in quality of life
• Patient Global Impression of Change scale (PGIC) [ Time Frame: 12 weeks ]
  Questionnaire reflecting effects of intervention (or non-intervention)from the participant's point of view

Original Secondary Outcome: Same as current

Information By: Projet Suisse d'Assistance Medicale

Dates:
Date Received: March 10, 2017
Date Started: May 2017
Date Completion: May 2018
Last Updated: March 22, 2017
Last Verified: March 2017