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Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia
This study has been completed.
Sponsored by: Hacettepe University
Information provided by: Hacettepe University
ClinicalTrials.gov Identifier: NCT00302887
  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

MedlinePlus related topics: Fibromyalgia Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study
Official Title: Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia

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

Ages Eligible for Study:   19 Years to 68 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers: HEK06/12-39
Study First Received: March 14, 2006
Last Updated: March 14, 2006
ClinicalTrials.gov Identifier: NCT00302887  
Health Authority: Turkey: Ethics Committee

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

Study placed in the following topic categories:
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009