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Sponsored by: |
Hacettepe University |
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Information provided by: | Hacettepe University |
ClinicalTrials.gov Identifier: | NCT00302887 |
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 |
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Fibromyalgia |
Device: combined ultrasound therapy Procedure: connective tissue manipulation |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | December 2004 |
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.
Ages Eligible for Study: | 19 Years to 68 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
Turkey | |
Hacettepe University, School of Physical Therapy and Rehabilitation | |
Ankara, Turkey, 06100 |
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. |
Study ID Numbers: | HEK06/12-39 |
Study First Received: | March 14, 2006 |
Last Updated: | March 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00302887 History of Changes |
Health Authority: | Turkey: Ethics Committee |
fibromyalgia connective tissue manipulation ultrasound therapy high voltage pulsed galvanic stimulation |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Rheumatic Diseases |