Anti-Depressants vs Physiotherapy in Management of Fibromyalgia
Anti-Depressants vs Physiotherapy in Management of Fibromyalgia
To compare the efficacy of physiotherapy and anti-depressants in disability reduction in
 patients of Fibromyalgia syndrome.
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.
Inclusion Criteria:

 -  Patient's between 18-60 yrs, belonging to either sex. With symptoms of chronic
 muscular pain of at least 12 weeks (that may or may not be consecutive) who fulfill
 the American College of Rheumatology (ACR) criteria for the diagnosis of Fibromyalgia

 Exclusion Criteria:

 -  Patients of age group more than 60 yrs and below 18 years

 -  Pregnant or lactating females.

 -  Patients with a history of trauma.

 -  Patients with severe co morbid illness which prevents physical activity (for example,
 cardiovascular problems)

 -  Patients with the presence of specific medical disorders which require immediate
 treatment (for example, fractures, infectious diseases),

 -  Patients with associated neurological abnormality