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Anti-Depressants vs Physiotherapy in Management of Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704899
First Posted: June 25, 2008
Last Update Posted: July 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahatma Gandhi Institute of Medical Sciences
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Anti-Depressants vs Physiotherapy in Management of Fibromyalgia Syndrome: What Predicts a Clinical Benefit?

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Reduction in Tender point score [ Time Frame: Two years ]
  • Reduction in Brief psychiatric rating score [ Time Frame: Two Years ]

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704899


Locations
India
Mahatma Gandhi Institute of Medical Sciences
Sevagram, Maharashtra, India, 442102
Sponsors and Collaborators
Mahatma Gandhi Institute of Medical Sciences
  More Information

Responsible Party: Prof AP Jain, Department of Medicine, MGIMS Sevagram
ClinicalTrials.gov Identifier: NCT00704899     History of Changes
Other Study ID Numbers: MGIMS-001
First Submitted: June 23, 2008
First Posted: June 25, 2008
Last Update Posted: July 4, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Amitriptyline
Antidepressive Agents
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants