Anti-Depressants vs Physiotherapy in Management of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of physiotherapy and anti-depressants in disability reduction in
      patients of Fibromyalgia syndrome.
    

Detailed description: 
      Research Question:

      Does the use of physiotherapy or pharmacotherapy help in improving quality of life in
      patients of fibromyalgia as judged by fibromyalgia impact questionnaire at a 6 month follow
      up period?

      Study hypothesis:

      Physiotherapy is no better than pharmacotherapy in improving the quality of life in patients
      of fibromyalgia as judged by fibromyalgia impact questionnaire.

      Study type- Interventional STUDY DESIGN: open label alternate patient treatment allocation
      Ethical approval for the trial protocol has been obtained from the institute's ethics
      committee of Mahatma Gandhi Institute of Medical Sciences, Sevagram.

      Subjects and Methods The study will be conducted in Kasturba Hospital and Mahatma Gandhi
      Institute of Medical Sciences, Sevagram, from 1 march 2006 - 1 dec 2007. Patients will be
      selected to enter the study, in such a way that every patient presenting with chronic
      muscular pain will be screened in the study and patients fulfilling inclusion criteria will
      be recruited in the study.

      Study population:

      Total of 175 patients will be included in the study.

      Methods:

      The investigators will screen all patients who are referred to them for inclusion in the
      study. Written informed consent will be obtained from all participants. The patients included
      in the study will be administered a standardized questionnaire to record socio-demographic
      characteristics, symptom characteristics and history of previous visits to a health care
      provider. The socio-economic score (SES) will be determined using a validated
      questionnaire.[6] Briefly, the questionnaire consists of following: (1) household profile,
      (2) material possession profile, (3) educational profile, (4) occupational profile, (5)
      economic profile (6) possessed land or house cost profile and (7) social profile.
      Fibromyalgia impact questionnaire (FIQ) will be used to determine a baseline score. [7] For
      the purpose of the study this questionnaire is translated to local language (Marathi), and
      back-translated to English to ensure its accuracy. Minor modifications have been done in the
      questionnaire to make it suitable for our setting (for example: the use of washer or dryer
      for laundry was modified to washing the laundry by themselves). Assessment of psychiatric co
      morbidity will be done using the Brief Psychiatric Rating Scale (BPRS), which is an 18 item
      instrument, each item has a seven severity grades.[8] A score of 32 or more indicates
      presence of psychopathology.[9]

      Interventions:

      A trained Physiotherapist will conduct a uniform structured physical training and aerobic
      session for one group of patients. The patients will be advised to perform the exercises
      daily twice for at least 10 minutes. There will be a step up pattern of exercise regimen
      followed with relaxation, stretching and strengthening techniques. The methodology is
      described in box 1. The second group of patients will receive antidepressant in the form open
      label amitriptyline 25 mg once daily at bedtime. The dose of the drug may be increased if
      required. All patients will be also offered pharmacologic treatment with 50 mg tramadol in
      thrice daily doses and as required. The treatment recommendations are based on standard
      recommendations on the management of fibromyalgia.[5]

      Outcome assessment All patients will be followed up for six months at monthly intervals. At
      each visit the study investigators will determine the course of the disease and compliance
      with therapy. The FIQ score will be assessed at the end of 6 monthly visits. Reduction in FIQ
      score from the baseline will be used as the principle outcome measure.
    

Intervention name(s): Physiotherapy; Amitryptiline
Intervention type(s): Procedure; Drug
Intervention description(s): Structured exercise regimen; Amitryptiline 25mg once daily
Intervention MeSH terms: Amitriptyline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment