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Anti-Depressants vs Physiotherapy in Management of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00704899
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : July 4, 2008
Sponsor:
Information provided by:
Mahatma Gandhi Institute of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Procedure: Physiotherapy Drug: Amitryptiline Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
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?
Study Start Date : March 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Reduction in FIQ score from the baseline [ Time Frame: Two years ]

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


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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

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

Responsible Party: Prof AP Jain, Department of Medicine, MGIMS Sevagram
ClinicalTrials.gov Identifier: NCT00704899     History of Changes
Other Study ID Numbers: MGIMS-001
First Posted: June 25, 2008    Key Record Dates
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