Anti-Depressants vs Physiotherapy in Management of Fibromyalgia

This study has been completed.

Sponsors and Collaborators:	Mahatma Gandhi Institute of Medical Sciences Department of Medicine, MGIMS Sevagram
Information provided by:	Mahatma Gandhi Institute of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00704899

Purpose

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

Condition	Intervention	Phase
Fibromyalgia	Procedure: Physiotherapy Drug: Amitryptiline	Phase III

MedlinePlus related topics: Antidepressants Fibromyalgia

Drug Information available for: Amitriptyline Amitriptyline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Anti-Depressants vs Physiotherapy in Management of Fibromyalgia Syndrome: What Predicts a Clinical Benefit?

Further study details as provided by Mahatma Gandhi Institute of Medical Sciences:

Primary Outcome Measures:

Reduction in FIQ score from the baseline [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in Tender point score [ Time Frame: Two years ] [ Designated as safety issue: No ]
Reduction in Brief psychiatric rating score [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Enrollment:	175
Study Start Date:	March 2006
Study Completion Date:	April 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental anti-depressants	Drug: Amitryptiline Amitryptiline 25mg once daily
1: Experimental physiotherapy	Procedure: Physiotherapy Structured exercise regimen

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704899

Locations

India, Maharashtra
Mahatma Gandhi Institute of Medical Sciences
Sevagram, Maharashtra, India, 442102

Sponsors and Collaborators

Mahatma Gandhi Institute of Medical Sciences

Department of Medicine, MGIMS Sevagram

More Information

Responsible Party:	Department of Medicine, MGIMS Sevagram ( Prof AP Jain )
Study ID Numbers:	MGIMS-001
Study First Received:	June 23, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00704899
Health Authority:	India: Indian Council of Medical Research

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Amitriptyline
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Antidepressive Agents, Tricyclic
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 05, 2009