Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT00302887
• Lead Sponsor: Hacettepe University

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.

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 Timeline

• Study Start: 2003-08
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Status Verified: 2006-03
• Study First Submitted: 2006-03-14
• Study First Submitted QC: 2006-03-14
• Study First Posted: 2006-03-15
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain intensity	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".

Trial Locations

Locations (1)

Hacettepe University, School of Physical Therapy and Rehabilitation; 🇹🇷 Ankara, Turkey