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Completed

NCT Number: NCT00302887

Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia

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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Key information

Age range

19 year–68 year

Sex eligibility

Female

Study type

Observational

Primary location

Hacettepe University, School of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

combined ultrasound therapy

Device

connective tissue manipulation

Procedure

Primary outcomes

  1. pain intensity

    Time frame: All evaluations were performed before and after 20 sessions of treatment.

    The intensity of pain was evaluated by 0-10 cm visual analogue scales (VASs). On the VAS, "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 15, 2006
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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