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

Effects of Pain Therapeutic Education and Hydrotherapy on Pain, Depression, Anxiety, Quality of Life and Quality of Sleep of Women With Fibromyalgia

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%.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Hydrotherapy; Other: Pain Education

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Carlos, SP, Brazil, 13565-905
      • Federal University of São Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain throughout time	Visual Analogue Scale (VAS - 100mm) for pain	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in number of active myofascial trigger points throughout time	Number of active myofascial trigger points	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in depression throughout time	Depression clinical symptoms (measured through Hospital Anxiety and Depression Scale)	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in anxiety throughout time	Anxiety clinical symptoms (measured through Hospital Anxiety and Depression Scale)	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Impact of Fibromyalgia in Quality of life throughout time	Quality of life measured through Revised Fibromyalgia Impact Questionnaire	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Quality of life throughout time	Quality of life measured through questionnaire Medical Outcomes Sudy 36-item Short-Form Health Survey (sf-36)	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Sleep throughout time	Sleep quality measured through two questionnaires: Pittsburgh Quality of Sleep Index and Epworth Sleepiness Scale	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Pain neurophysiology learning throughout time	For the Pain Therapeutic Education group, index of Pain Neurophysiology learning with an specific questionnaire	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in knowledge of Fibromyalgia throughout time	Fibromyalgia Knowledge will be measured through Fibromyalgia Knowledge Questionnaire	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Changes in Appraisal of Self-Care Agency throughout time	Appraissal of Self-Care Agency through The Appraisal of Self-Care Agency Scale - Revised (ASAS-R) scores	Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Pacient satisfaction with the intervention	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.	After 6 and 12 weeks of treatment and after 12 weeks of treatment completion.
Patient's perception of change	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.	After 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Investigators: Principal Investigator: Mariana A Avila, Ph.D., Ufscar

Publications and helpful links

General Publications

• Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013 Aug;17(8):356. doi: 10.1007/s11916-013-0356-5.
• Ortega E, Bote ME, Giraldo E, Garcia JJ. Aquatic exercise improves the monocyte pro- and anti-inflammatory cytokine production balance in fibromyalgia patients. Scand J Med Sci Sports. 2012 Feb;22(1):104-12. doi: 10.1111/j.1600-0838.2010.01132.x. Epub 2010 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): November 3, 2020

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pain education; Hydrotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: UFSCarFMS; 2017/03278-0 (Other Grant/Funding Number: FAPESP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All results shall be disclosed in a form that no individual volunteers shall be identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No