Clinical trial NCT00302887: Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia
Official title: Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: fibromyalgia
connective tissue manipulation
ultrasound therapy
high voltage pulsed galvanic stimulation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2006-03-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pain intensity
timeFrame: All evaluations were performed before and after 20 sessions of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, School of Physical Therapy and Rehabilitation
Study officials:
affiliation: PT. PhD. Assist. Prof.
name: İlkim Çıtak Karakaya, PT. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: PT. PhD. Assoc. Prof.
name: Türkan Akbayrak, PT. PhD.
role: STUDY_DIRECTOR
affiliation: Research assistant
name: Funda Demirtürk, PT. PhD.
role: STUDY_CHAIR
affiliation: Research assistant
name: Gamze Ekici, PT. MSc.
role: STUDY_CHAIR
affiliation: Assist. Prof.
name: Yeşim Bakar, PT. PhD.
role: STUDY_CHAIR
References: