Clinical trial NCT01839305: Effects of Hydrotherapy on Physical Function and Quality of Life of Women With Fibromyalgia
Official title: Effects of Hydrotherapy on 3D Scapular Kinematics, Electromyography, Pain, Quality of Life, Balance and Cardiorespiratory Variables in Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Kinematics
Fibromyalgia
Physical Therapy
3D Kinematics
Heart Rate Frequency
Hydrotherapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fibromyalgia Syndrome (FS) is one condition that most affects functional performance, especially in women, due to alterations in the entire musculoskeletal system. Given that, Physical Therapy (PT) studies the human movement and its dysfunctions, and that FS, because of its complex chronic characteristic, impairs the affected individual's activities causing movement disorders, a PT professional must be part of the multidisciplinary team involved in the FS treatment. Nonetheless, as explained in the present proposal, several aspects still need clarification related to the PT role in this syndrome. Particularly, studies that analyze the biomechanical, sensorial and cardiorespiratory adaptations in individuals who undergo PT intervention still lack; those studies would contribute with scientific evidence to the clinical practice. According to recent systematic reviews, one of the most used therapies with positive effects on FS subjects is the hydrotherapy, which combines exercises and the water relaxing effects. Other alternative treatments have also been searched, in an attempt to decrease the painful picture presented, as the FS etiology and pathophysiology are not well known. The aim of this study is to evaluate the efficacy of different physical therapy resources in the FS, in two subprojects. The first will verify if hydrotherapy is effective in modifying movement variables (scapular kinematics and electromyography) and autonomic modulation. Other variables, such as pain level and quality of life in women with FS, will also be analyzed. The second study will evaluate the efficacy of the Shiatsu massage on pain, sleep quality, balance and quality of life of subjects with FS.

Detailed description: Subjects were invited to take part in several assessments before starting the actual Hydrotherapy Treatment. These assessments were:

1. Three-dimensional scapular evaluation
2. Questionnaires (FIQ, SF-36, Beck Depression Inventory, Beck Anxiety Inventory, Pittsburgh Quality of Sleep Index)
3. Pain (pressure pain threshold and trigger points) Subjects were evaluated 3 times one month before starting treatment, one time in the middle of treatment and after treatment completion.

Treatment lasted 16 weeks and consisted of 2 weekly 45' hydrotherapy sessions.

Eligibility criteria: Inclusion Criteria:

* to have a clinical fibromyalgia diagnosis according to the 1990 ACR criteria
* to be aged from 30 to 60 years old.

Exclusion Criteria:

* Body Mass index \>28kg/m²
* Cognitive deficits that prevented patients to understand the evaluation procedures
* Uncontrolled systemic illnesses (e.g. diabetes mellitus and systemic arterial hypertension)
* Neurological and musculoskeletal conditions that could have directly interfered in the evaluations, as paresis, important sensitive alterations, advanced joint diseases (e.g. arthroplasties or osteoarthritis)
* Infections
* Urinary incontinence
* Pregnancy

Primary outcomes:
measure: Pain
timeFrame: up to 5 months from the initial interview
Secondary outcomes:
measure: 3D Kinematics and electromyography
timeFrame: up to 5 months from the initial interview
Other outcomes:
measure: Balance
timeFrame: up to 5 months from the initial interview
measure: Function
timeFrame: up to 5 months from the initial interview
measure: Cardiorespiratory Status
timeFrame: up to 5 months from initial interview
Locations:
city: São Carlos
country: Brazil
facility: Academia O2
state: SP
Study officials:
affiliation: UFSCar
name: Tania F Salvini, PhD
role: STUDY_DIRECTOR
affiliation: UFSCar
name: Antonio Roberto Zamunér, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UFSCar
name: Deborah C Trevisan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UFSCar
name: Ester Silva, PhD
role: STUDY_CHAIR
affiliation: UFSCar
name: Paula R Camargo, PhD
role: STUDY_CHAIR
affiliation: UFSCar
name: Patricia Driusso, PhD
role: STUDY_CHAIR
References:
citation: Zamuner AR, Andrade CP, Forti M, Marchi A, Milan J, Avila MA, Catai AM, Porta A, Silva E. Effects of a hydrotherapy programme on symbolic and complexity dynamics of heart rate variability and aerobic capacity in fibromyalgia patients. Clin Exp Rheumatol. 2015 Jan-Feb;33(1 Suppl 88):S73-81. Epub 2015 Mar 18.