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Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302887
First Posted: March 15, 2006
Last Update Posted: March 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hacettepe University
  Purpose
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.

Condition Intervention
Fibromyalgia Device: combined ultrasound therapy Procedure: connective tissue manipulation

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Hacettepe University:

Estimated Enrollment: 20
Study Start Date: August 2003
Estimated Study Completion Date: December 2004
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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): NCT00302887


Locations
Turkey
Hacettepe University, School of Physical Therapy and Rehabilitation
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
Principal Investigator: İlkim Çıtak Karakaya, PT. PhD. PT. PhD. Assist. Prof.
Study Director: Türkan Akbayrak, PT. PhD. PT. PhD. Assoc. Prof.
Study Chair: Funda Demirtürk, PT. PhD. Research assistant
Study Chair: Gamze Ekici, PT. MSc. Research assistant
Study Chair: Yeşim Bakar, PT. PhD. Assist. Prof.
  More Information

ClinicalTrials.gov Identifier: NCT00302887     History of Changes
Other Study ID Numbers: HEK06/12-39
First Submitted: March 14, 2006
First Posted: March 15, 2006
Last Update Posted: March 15, 2006
Last Verified: March 2006

Keywords provided by Hacettepe University:
fibromyalgia
connective tissue manipulation
ultrasound therapy
high voltage pulsed galvanic stimulation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases