Anti-Depressants vs Physiotherapy in Management of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Mahatma Gandhi Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00704899
First received: June 23, 2008
Last updated: June 25, 2008
Last verified: June 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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
Experimental: 2
anti-depressants
Drug: Amitryptiline
Amitryptiline 25mg once daily
Experimental: 1
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
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 ClinicalTrials.gov identifier: NCT00704899

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

No publications provided

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

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 18, 2014