Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assesses the benefits of intervention with gabapentin, Osteopathic Manipulative
      Medicine or both for improvement of the symptoms of Fibromyalgia. This study also seeks to
      determine whether these treatments will decrease the number and severity of tender points,
      improve structure, function and the overall pain level of each patient from the baseline of
      the study to the end. This study is designed to evaluate whether subjects subjectively
      experience an improved quality of life and increased function as a result of these
      interventions corresponding to objective improvements.
    

Detailed description: 
      An 8-week, randomized, study was designed to compare gabapentin (900 mg/day) (n = 8 patients)
      with OMM (n = 11 patients) with Combined treatment of gabapentin (900 mg/day) plus OMM (n = 7
      patients) for efficacy and safety in treating pain, fatigue, depression and function
      associated with fibromyalgia.

      The primary outcome measures were measured during week 2 and week 8 to evaluate efficacy of
      each arm and compare efficacy between each arm at improving structure, function and pain. The
      Baker Wong Brief Pain Inventory (BPI) was evaluated weekly for average pain severity score
      (range 0-10, where 0 = no pain and 10 = pain as bad as you can imagine). Fibromyalgia Impact
      Questionnaire (FIQ) a tool that evaluates function and health status was administered at week
      2 and week 8 for comparison of functioning at the baseline and end of the study. The total
      number of Tender Points (0-18) as determined by the American College of Rheumatology was
      counted at week 2 and week 8 to compare number of tender points from the baseline to the end.
      Dolorimetry in Kg/cm2 as measured by the Fischer Dolorimeter were measured on the 4 most
      severe tender points at week 2 and week 8 to compare severity of tender points from baseline
      to end of study. The Osteopathic Structural Examination which measures free range of motion
      of joints in degrees was measured with goniometry at week 2 and week 8 to evaluate degrees of
      free range of motion improved from baseline. The Clinical Global Impression which is a likert
      scale of 1-5 asking patients to evaluate how they feel about their overall health was taken
      at week 2 and week 8 to see if overall subjective thoughts of health were improved from
      baseline.
    

Intervention name(s): Gabapentin; Osteopathic Manipulative Medicine; Gabapentin and Osteopathic Manipulative Medicine
Intervention type(s): Drug; Procedure; Other
Intervention description(s): Gabapentin 900 mg po HS for 6 weeks treatment per patients enrolled in the Gabapentin Arm; Based on Osteopathic Structural Examination and Tender point Examination a 30 minute treatment of Osteopathic Manipulative Medicine was applied to each patient every week for 6 weeks.; Combination therapy of gabapentin 900 mg po HS for 6 weeks and Osteopathic Manipulative Medicine 30 minute treatment weekly for each patient based on Osteopathic Structural Examination and Tender point Examination
Other intervention name(s): Neurontin; Osteopathic Manipulation Treatment; Combined OMM and Neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pain, tenderpoints, insomnia, mood disorder, fatigue