Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients
Condition: Non-celiac Wheat Sensitivity
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Synovitis; Myalgia; Hypersensitivity
Study type: Interventional

Summary: 
      Recently it has been reported that a consistent percentage of the general population consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac
      Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term
      'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes
      the symptoms in NCGS patients, and the investigators also showed that these patients had a
      high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is
      characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and
      extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,
      and anemia). Nowadays no data are available on the characteristic of 'rheumatologic' symptoms
      of NCWS patients. Therefore, the aims of the present study are: 1) to investigate the
      prevalence of fibromyalgia-like joint/muscle pain in NCWS patient, 2) to search for possible
      ultrasonographic alterations (i.e. synovitis) of hands and feet joints of NCWS patients, and
      3) to evaluate modification of fibromyalgia-like joint/muscle pain in NCWS patients after a
      gluten free diet period of almost 6 months.
    

Detailed description: 
      Recently it has been reported that a consistent percentage of the general population consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac
      Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term
      'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes
      the symptoms in NCGS patients, and the investigators also showed that these patients had a
      high frequency of coexistent multiple food hypersensitivity. CD is an immunological disorder
      whose best-known manifestations are gastrointestinal symptoms. However, early joint
      manifestations are common and frequently overlooked features of the disease. Similarly, the
      clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal
      pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux,
      aphthous stomatitis) and extra-intestinal and/or systemic manifestations (headache,
      depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like
      joint/muscle pain, leg or arm numbness, and anemia). Nowadays no data are available on the
      characteristic of 'rheumatological' symptoms of NCWS patients. Therefore, the aims of the
      present study are: 1) to investigate the prevalence of fibromyalgia-like joint/muscle pain in
      NCWS patient, 2) to search for possible ultrasonographical alterations (i.e. synovitis) of
      hands and feet joints of NCWS patients, and 3) to evaluate modification of fibromyalgia-like
      joint/muscle pain in NCWS patients after a gluten free diet period of almost 6 months.
    

Intervention name(s): Gluten free diet
Intervention type(s): Other
Intervention description(s): The investigators will evaluate the prevalence of fibromyalgia-like joint/muscle pain and the possible ultrasonographical alterations (i.e. synovitis) of hands and feet joints in NCWS patient at baseline (i.e. at the moment of diagnosis) and after a gluten free diet period of almost 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Non-celiac Wheat Sensitivity; fibromyalgia; synovitis