Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia

NCT ID: NCT00302887

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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combined ultrasound therapy

Intervention Type DEVICE

connective tissue manipulation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

68 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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İlkim Çıtak Karakaya

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İlkim Çıtak Karakaya, PT. PhD.

Role: PRINCIPAL_INVESTIGATOR

PT. PhD. Assist. Prof.

Türkan Akbayrak, PT. PhD.

Role: STUDY_DIRECTOR

PT. PhD. Assoc. Prof.

Funda Demirtürk, PT. PhD.

Role: STUDY_CHAIR

Research assistant

Gamze Ekici, PT. MSc.

Role: STUDY_CHAIR

Research assistant

Yeşim Bakar, PT. PhD.

Role: STUDY_CHAIR

Assist. Prof.

Locations

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Hacettepe University, School of Physical Therapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HEK06/12-39

Identifier Type: -

Identifier Source: org_study_id

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