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NCT00302887 Clinical Trial

Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00302887
Other study ID # HEK06/12-39
Secondary ID
Status Completed
Phase N/A
First received March 14, 2006
Last updated March 14, 2006
Start date August 2003
Est. completion date December 2004

Study information
Verified date March 2006
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study was to evaluate the short term and one year follow-up results of connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact on the functional activities in patients with fibromyalgia.

Description:

This is an observational prospective cohort study, investigating short and long term results of physiotherapy applications in 20 female patients with fibromyalgia. Physical characteristics of the subjects were recorded. Intensity of pain, complaint of non-restorative sleep, and impact of fibromyalgia on functional activities were evaluated by visual analogue scales. All evaluations were performed before and after 20 sessions of treatment, which included connective tissue manipulation of the back daily, for a total of 20 sessions and combined ultrasound therapy of the upper back region every other session. One year follow-up evaluations could be performed on 14 subjects.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 68 Years
Eligibility Inclusion Criteria:

Women with pain depending to FM, with an intensity interfering to activities of daily living for a duration of at least six months, able to participate of 20 physiotherapy sessions within a four week period, volunteer for participating to the study without taking any drugs acting on the nervous system such as antidepressants, myorelaxants, analgesics or hypnotics, in the study period.

Exclusion Criteria:

evidence of neurological, infectious, endocrine and other inflammatory rheumatic diseases, and experience with any kind of manual and/or electrotherapy, within six months before the study.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Device:
• combined ultrasound therapy

Procedure:
• connective tissue manipulation

Locations
Country Name City State
Turkey Hacettepe University, School of Physical Therapy and Rehabilitation Ankara

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

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