Fibromyalgia
Conditions
Keywords
Fibromyalgia, Education, Strength training
Brief summary
The main goal of this study is to get to know if applying both, pain neuroscience education (PNE) plus strength training (ST) will reduce the pain of fibromyalgia (FM). Both therapies have shown evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their efficacy in combination.
Detailed description
At present, the increase in knowledge about the neuroscience of pain has led to the integration of psychological factors, such as cognitions and beliefs about pain, fear-avoidance behaviors or catastrophism within the integrative perception of the concept . This has led to the development of therapeutic strategies aimed at the reconceptualization of pain through a treatment method called Pain Neuroscience Education (PNE), having shown evidence in the treatment of pain, disability, catastrophism and physical performance. But despite current advances in pain neuroscience, there are still pain syndromes, such as fibromyalgia, that are the subject of debate and controversy. Fibromyalgia is a syndrome that causes generalized musculoskeletal pain, fatigue, sleep disorders, and physical disability. It is the main cause of chronic generalized musculoskeletal pain, with a prevalence of 1-5% of the world population. Scientific research has provided new insight for the diagnosis of fibromyalgia patients, who are characterized by a central sensitization process. Objectives: To assess the effectiveness of Pain Neuroscience Education and Strength Training to decrease pain and disability; and increasing quality of life and functionality in patients with Fibromyalgia.
Interventions
PROCEDUREPAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
The subjects of this group will receive an amount of six sessions that will be applied within 12 weeks. Every 15 days, the subjects will come for a consultation to receive a PNE session and review of the exercise program, which will be carried out 3 times a week for 12 weeks.
PROCEDUREUSUAL CARE
Aerobic exercises will consist of a standard table of low intensity stretching exercises, commonly prescribed to fibromyalgia patients. There will be three series of 30 seconds of each stretch, having a total duration of approximately 40 minutes. Each session will be held twice a week, following the recommendations of the American College of Sport Medicine. Monitoring will be performed every 15 days by a physiotherapist.
Sponsors
Manuel Rebollo Salas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Women diagnosed with fibromyalgia. * Duration of pain greater than one year. * Generalized or present pain in more than two body regions. * Not having participated in pain neuroscience education program. * Not having participated in physical exercise programs in the last three months.
Exclusion criteria
* Presence of other diseases not related to the musculoskeletal system. * Being under medical treatment not related to pain. * being under physiotherapeutic treatment related to pain. * Unavailability to carry out a physical exercise program. * Pregnant or puerperium women. * Inability to perform or complete the necessary tests to measure the study variables.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Self-report Pain Intensity | at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week). | Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity |
| Change from Central Sensitization symptoms | at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week) | Measured by the Central Sensitization Inventory (CSI). The total CSI score is between 0-100 points. Scores equal to or greater than 40 points are considered positive for Central Sensitization. |
| Change from Disability | at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week) | Measured by the Fibromyalgia Impact Questionnaire (FIQ). The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from grip strength | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | Measure by the dynamometer. |
| Change from viscoelastic properties. | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | Measured by the Myoton®. |
| Change from the pressure pain threshold | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | Measure by the pressure algometer. |
| Change from Autonomic Disfunction symptoms | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | Measured by the Heart Rate Variability. |
| Change from Nerve Conduction Velocity | at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)] | Measured by the Sensory Nerve Action Potential (SNAP). |
Countries
Spain
Outcome results
None listed