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Anti-Depressants vs Physiotherapy in Management of Fibromyalgia

This study has been completed.
Information provided by:
Mahatma Gandhi Institute of Medical Sciences Identifier:
First received: June 23, 2008
Last updated: June 25, 2008
Last verified: June 2008
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
Drug: Amitryptiline
Amitryptiline 25mg once daily
Experimental: 1
Procedure: Physiotherapy
Structured exercise regimen

  Show Detailed Description


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00704899

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 Identifier: NCT00704899     History of Changes
Other Study ID Numbers: MGIMS-001
Study First Received: June 23, 2008
Last Updated: June 25, 2008

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Antidepressive Agents
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Analgesics, Non-Narcotic
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 processed this record on September 21, 2017