Anti-Depressants vs Physiotherapy in Management of Fibromyalgia

NCT ID: NCT00704899

Last Updated: 2008-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-04-30

Brief 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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

anti-depressants

Group Type: EXPERIMENTAL

Amitryptiline

Intervention Type: DRUG

Amitryptiline 25mg once daily

1

physiotherapy

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: PROCEDURE

Structured exercise regimen

Interventions

Physiotherapy

Structured exercise regimen

Intervention Type: PROCEDURE

Amitryptiline

Amitryptiline 25mg once daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahatma Gandhi Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Department of Medicine, MGIMS Sevagram

Locations

Mahatma Gandhi Institute of Medical Sciences

Sevāgrām, Maharashtra, India

Countries

India

Other Identifiers

MGIMS-001

Identifier Type: -

Identifier Source: org_study_id