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

NCT ID: NCT03073642

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-11-03

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%.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hydrotherapy

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Pain Education

Intervention Type: OTHER

Together with hydrotherapy, patients will receive pain therapeutic education

Hydrotherapy

Intervention Type: OTHER

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

Interventions

Pain Education

Together with hydrotherapy, patients will receive pain therapeutic education

Intervention Type: OTHER

Hydrotherapy

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

Intervention Type: OTHER

Other Intervention Names

Pain Neuroscience Education, Pain Therapeutic Education

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Mariana Arias Avila

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana A Avila, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UFSCar

Locations

Federal University of São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

References

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

Reference Type: BACKGROUND

PMID: 23801009 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20536907 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37070715 (View on PubMed)

Other Identifiers

2017/03278-0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UFSCarFMS

Identifier Type: -

Identifier Source: org_study_id