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

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ClinicalTrials.gov Identifier: NCT03073642
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mariana Arias Avila, Universidade Federal de Sao Carlos

Brief Summary:
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 or disease Intervention/treatment Phase
Fibromyalgia Other: Pain Education Other: Hydrotherapy Not Applicable

Detailed Description:

The investigators will select at least 80 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized controlled trial with 1:1 allocation
Masking: Double (Care Provider, Investigator)
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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Fibromyalgia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Changes in Pain throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Visual Analogue Scale (VAS - 100mm) for pain


Secondary Outcome Measures :
  1. 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

  2. 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 Hospital Anxiety and Depression Scale)

  3. 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 Hospital Anxiety and Depression Scale)

  4. 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 Revised Fibromyalgia Impact Questionnaire

  5. 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)

  6. 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

  7. 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

  8. Changes in knowledge of Fibromyalgia throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Fibromyalgia Knowledge will be measured through Fibromyalgia Knowledge Questionnaire

  9. Changes in Appraisal of Self-Care Agency throughout time [ Time Frame: Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Appraissal of Self-Care Agency through The Appraisal of Self-Care Agency Scale - Revised (ASAS-R) scores

  10. Pacient satisfaction with the intervention [ Time Frame: After 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Structured questionnaire through which patient will answer about satisfaction with treatment, with a 5-point Likert Scale, with the possible asnswers: "Totally Agree", "Agree", "Neutral", "Disagree" and "Totally Disagree", relative to the following affirmations: 1) I am satisfied with the treatment I received; 2) I believe this treatment was helpful for my condition; 3) I believe my health status has improved after treatment; 4) I will include in my daily life activities things I have learned during my treatment; 5) I will recommend this treatment to someone who has the same health condition as me.

  11. Patient's perception of change [ Time Frame: After 6 and 12 weeks of treatment and after 12 weeks of treatment completion. ]
    Self-perception of change with the Global Rating of Change Scale; with this scale from -7 to 7, the participant will rate her perception of change after intervention. The negative values will be considered as a worsening in the health status, and the positive values, as a improvement in the health condition of the participant. Zero will be considered as no change in the health status.



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

Inclusion Criteria:

  • Clinical and medical Fibromyalgia Diagnosis according to ACR Diagnostic criteria 2010 and 2016;
  • 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;
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073642


Contacts
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Contact: Mariana A Avila, Ph.D. +551633519791 maafisio01@gmail.com
Contact: Mariana A Avila, Ph.D. +551633519791

Locations
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Brazil
Federal University of São Carlos Recruiting
Sao Carlos, SP, Brazil, 13565-905
Contact: Mariana A Avila, Ph.D.    +551633518633    maafisio01@gmail.com   
Principal Investigator: Mariana A Avila, Ph.D.         
Sub-Investigator: Breno P Lourenço, PT Undergrad         
Sub-Investigator: Airton P Souza-Júnior, PT Undergrad         
Sub-Investigator: Ana Luiza A Camargo, PT Undergrad         
Sub-Investigator: Thalita F França, PT         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
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Principal Investigator: Mariana A Avila, Ph.D. UFSCar

Publications:
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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
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All results shall be disclosed in a form that no individual volunteers shall be identified.

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

Keywords provided by Mariana Arias Avila, Universidade Federal de Sao Carlos:
Hydrotherapy
Pain education

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