Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia

March 11, 2025 updated by: İlkim Çıtak Karakaya, Hacettepe University

Short and Long Term Results of 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.

Study Overview

Status

Completed

Conditions

Fibromyalgia

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - Ankara, Turkey, 06100
    - Hacettepe University, School of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The sample was derived from a population of 83 FM outpatients of the Hacettepe University School of Physical Therapy and Rehabilitation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	All evaluations were performed before and after 20 sessions of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria