Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 40 of 120 for:    fibromyalgia | Open Studies

Effects of Pain Therapeutic Education and Hydrotherapy on Physical Function, Pain and Sleep of Women With Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Universidade Federal de Sao Carlos
Sponsor:
Information provided by (Responsible Party):
Mariana Arias Avila, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT03073642
First received: February 20, 2017
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
Fibromyalgia (FM) is a prevalent and disabling disease, that affects mostly women and its main characteristic is chronic pain. Several studies have shown that hydrotherapy is effective in the improvement of symptoms and quality of life of this population; other studies have shown that Pain Therapeutic Education (PTE) is also effective in this sense. PTE is one cheap, easy to apply intervention, with very positive results in chronic pain situations. However, there is a lack of studies that have shown the effects of this intervention on FM. Hence, this study will aim to verify the effectiveness of the hydrotherapy and PTE on women with FM. Sixty women will be randomly allocated in two groups: hydrotherapy and hydrotherapy + PTE. Before treatment start, the investigators will evaluate pain (visual analogue scale, presence of myofascial trigger points and pressure pain threshold over the scalene, upper trapezius, infraspinatus, piriformis, iliopsoas and soleus, bilaterally), quality of life (Fibromyalgia Impact Questionnaire and medical outcomes study 36-item short-form health survey), depression (Beck Depression Inventory), anxiety (Beck Anxiety Inventory) and sleep quality (Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale). Hydrotherapy treatment will last 12 weeks. Women will be evaluated other 3 times: after 6 and 12 weeks (treatment middle and end) and 12 weeks after treatment completion (follow-up). Women in the hydrotherapy group will receive a folder with explanations on FM. Women in the hydrotherapy + PTE will participate of 4 meetings over 12 treatment weeks, in which themes like pain physiology, pain chronification and exacerbation and pain self-management, as well as information on FM will be approached. Statistical analysis will include qualitative and quantitative variable description. Correlation among variables will also be analyzed. Level of significance will be set at 5%.

Condition Intervention
Fibromyalgia
Other: Pain Education
Other: Hydrotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double blind randomized controlled trial with 1:1 allocation
Masking: Care Provider, Outcomes Assessor
Masking Description:
Outcomes assessor will not know in which group volunteers are allocated; Care provider will not know outcome measures for any volunteers before study completion.
Primary Purpose: Treatment
Official Title: Effects of Pain Therapeutic Education and Hydrotherapy on Pain, Depression, Anxiety, Quality of Life and Quality of Sleep of Women With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • Changes in Pain throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Pain measured through Pressure Pain Threshold (kPa)


Secondary Outcome Measures:
  • Changes in number of active myofascial trigger points throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Number of active myofascial trigger points

  • Changes in depression throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Depression clinical symptoms (measured through Beck Depression Inventory)

  • Changes in anxiety throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Anxiety clinical symptoms (measured through Beck Anxiety Inventory)

  • Changes in Impact of Fibromyalgia in Quality of life throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Quality of life measured through Fibromyalgia Impact Questionnaire

  • Changes in Quality of life throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Quality of life measured through questionnaire Medical Outcomes Sudy 36-item Short-Form Health Survey (sf-36)

  • Changes in Sleep throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Sleep quality measured through two questionnaires: Pittsburgh Quality of Sleep Index and Epworth Sleepiness Scale

  • Changes in Pain neurophysiology learning throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    For the Pain Therapeutic Education group, index of Pain Neurophysiology learning with an specific questionnaire


Estimated Enrollment: 60
Anticipated Study Start Date: July 1, 2017
Estimated Study Completion Date: July 1, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydrotherapy

Patients allocated to this group will perform 12 weeks of hydrotherapy treatment, with global exercises. Hydrotherapy sessions will last 45 minutes and will be performed twice a week.

Exercises will involve aerobic exercises (in the pool) with exercises for upper and lower limbs, and trunk.

Other: Hydrotherapy
Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.
Experimental: Hydrotherapy and Pain Education

Patients allocated to this group will perform 12 weeks of hydrotherapy treatment, with global exercises. Hydrotherapy sessions will last 45 minutes and will be performed twice a week.

Exercises will involve aerobic exercises (in the pool) with exercises for upper and lower limbs, and trunk.

During the 12 weeks of hydrotherapy treatment, volunteers will also receive 4 sessions of Pain Therapeutic Education, which is also known as Pain Neuroscience Education, which involves patient education on pain neurophysiology, pain chronification and amplification mechanisms, and chronic pain management. These sessions will be performed in specific dates scheduled according to the volunteers' availability, and with intervals that can last from one to two weeks.

Other: Pain Education
Together with hydrotherapy, patients will receive pain therapeutic education
Other Name: Pain Neuroscience Education, Pain Therapeutic Education
Other: Hydrotherapy
Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.

Detailed Description:

The investigators will select at least 60 women with fibromyalgia (FM) for this study, in which pain (through pressure pain threshold and number of active myofascial trigger points), quality of life, FM impact on quality of life and function, depression, anxiety and quality of sleep will be evaluated.

After evaluating the volunteer, the participant will be randomly allocated to one of two groups: hydrotherapy treatment (HT), and hydrotherapy treatment together with pain therapeutic education (HT+PTE).

All volunteers will perform 12 weeks of hydrotherapy treatment, in which the investigators will perform global exercises for upper and lower limbs and trunk.

Volunteers in the HT+PTE group will receive, throughout the 12 weeks of HT, 4 sessions of PTE, in which the investigators will teach pain neurophysiology, pain chronification and pain management.

Evaluation sessions will take place before treatment, after 6 and 12 weeks of HT and after 12 weeks of treatment ending.

In all evaluations sessions, the investigators will collect data on those aspects previously described.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical and medical Fibromyalgia Diagnosis;
  • Willing to perform hydrotherapy as treatment.

Exclusion Criteria:

  • Cognitive deficits that prevent volunteers from understanding evaluation and treatment procedures;
  • Uncontrolled systemic illnesses (diabetes, hypertension);
  • Neurological and musculoskeletal conditions that may interfere in the evaluation and treatment procedures (palsies, sensitivity alterations, advanced osteoarthritis);
  • Infecto-contagious illnesses (especially in the urinary tract);
  • Alcohol or drug abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03073642

Contacts
Contact: Mariana A Avila, Ph.D. maafisio01@gmail.com

Locations
Brazil
Federal University of São Carlos
Sao Carlos, SP, Brazil, 13565-905
Sponsors and Collaborators
Universidade Federal de Sao Carlos
  More Information

Publications:
Responsible Party: Mariana Arias Avila, PT, Ph.D., Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT03073642     History of Changes
Other Study ID Numbers: UFSCarFMS
Study First Received: February 20, 2017
Last Updated: March 7, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: All results shall be disclosed in a form that no individual volunteers shall be identified.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidade Federal de Sao Carlos:
Hydrotherapy
Pain education

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 28, 2017