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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | March 14, 2006 | ||||||||||||||||||||
| Last Updated Date | March 14, 2006 | ||||||||||||||||||||
| Start Date ICMJE | August 2003 | ||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia | ||||||||||||||||||||
| Official Title ICMJE | Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia | ||||||||||||||||||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Longitudinal, Defined Population, Prospective Study | ||||||||||||||||||||
| Condition ICMJE | Fibromyalgia | ||||||||||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||||||||||
| Publications * | |||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Enrollment ICMJE | 20 | ||||||||||||||||||||
| Completion Date | December 2004 | ||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Female | ||||||||||||||||||||
| Ages | 19 Years to 68 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | Turkey | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00302887 | ||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||
| Study ID Numbers ICMJE | HEK06/12-39 | ||||||||||||||||||||
| Study Sponsor ICMJE | Hacettepe University | ||||||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Hacettepe University | ||||||||||||||||||||
| Verification Date | March 2006 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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