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

NCT03073642 | Completed

• 2 other identifiers: UFSCarFMS2017/03278-0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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%.

Conditions

Fibromyalgia

Keywords

Hydrotherapy; Pain education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in number of active myofascial trigger points throughout time

  Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

• Changes in depression throughout time

  Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

• Changes in anxiety throughout time

  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

  Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

• Changes in Quality of life throughout time

  Before treatment, after 6 and 12 weeks of treatment and after 12 weeks of treatment completion.

Study Arms (2)

Hydrotherapy

ACTIVE COMPARATOR

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 and Pain Education

EXPERIMENTAL

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; Other: Hydrotherapy

Interventions

Pain Education OTHER

Together with hydrotherapy, patients will receive pain therapeutic education

Also known as: Pain Neuroscience Education, Pain Therapeutic Education

Hydrotherapy and Pain Education

Hydrotherapy OTHER

Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.

Hydrotherapy; Hydrotherapy and Pain Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and medical Fibromyalgia Diagnosis according to ACR Diagnostic criteria 2010 and 2016;
• Willing to perform hydrotherapy as treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (3)

• Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013 Aug;17(8):356. doi: 10.1007/s11916-013-0356-5.

  PMID: 23801009 BACKGROUND

• 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.

  PMID: 20536907 BACKGROUND

• Sousa AP, Almeida LA, Lourenco BP, Alvares LD, Avila MA. Pain neuroscience education improves quality of life when added to aquatic exercise therapy for women with fibromyalgia: randomized controlled clinical trial. Disabil Rehabil. 2024 Apr;46(8):1559-1569. doi: 10.1080/09638288.2023.2201510. Epub 2023 Apr 18.

  PMID: 37070715 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Mariana A Avila, Ph.D.

  UFSCar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Outcomes assessor will not know in which group volunteers are allocated; Care provider will not know outcome measures for any volunteers before study completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blind randomized controlled trial with 1:1 allocation

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 8, 2017
• Study Start: April 1, 2019
• Primary Completion: October 31, 2020
• Study Completion: November 3, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)