NCT00704899

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
Last Updated

July 4, 2008

Status Verified

June 1, 2008

Enrollment Period

1.8 years

First QC Date

June 23, 2008

Last Update Submit

June 25, 2008

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Reduction in FIQ score from the baseline

    Two years

Secondary Outcomes (2)

  • Reduction in Tender point score

    Two years

  • Reduction in Brief psychiatric rating score

    Two Years

Study Arms (2)

2

EXPERIMENTAL

anti-depressants

Drug: Amitryptiline

1

EXPERIMENTAL

physiotherapy

Procedure: Physiotherapy

Interventions

PhysiotherapyPROCEDURE

Structured exercise regimen

1
AmitryptilineDRUG

Amitryptiline 25mg once daily

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahatma Gandhi Institute of Medical Sciences

Sevāgrām, Maharashtra, 442102, India

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

April 1, 2008

Last Updated

July 4, 2008

Record last verified: 2008-06

Locations

IN(1)