Fibromyalgia (FM)
Conditions
Keywords
Fibromyalgia, central sensitization, Pain, intracortical excitability, HIIT - HIGH-INTENSITY INTERVAL TRAINING, tDCS - transcranial direct stimulation, transcranial magnetic stimulation
Brief summary
Exercise is recommended for people with fibromyalgia because it can reduce symptoms and improve quality of life. Some studies show that high-intensity exercises like running or cycling (also called high-intensity interval training, or HIIT) may reduce symptoms more effectively than slower, traditional exercises. There are also new treatments, like non-invasive neuromodulation, which uses a gentle current to stimulate brain cells. This technique can help reduce pain in people with fibromyalgia. However, we don't yet know if combining HIIT and neuromodulation works better than exercise alone. We also want to find out if this combination helps improve other symptoms like fatigue and poor sleep. The goal of this study is to see how a combination of HIIT and neuromodulation affects pain, fatigue, sleep, and muscle strength in women with fibromyalgia. The investigators are asking two main questions: Does combining HIIT and neuromodulation reduce pain better than exercise alone? Does this combination improve how the brain controls pain, muscles, and other symptoms like fatigue and sleep problems? What Will the Study Involve? Three different exercise training programs will be compared: HIIT with neuromodulation (tDCS): The participant will do HIIT by cycling at a high intensity for 1 minute, then resting for 2 minutes. Then, this will be repeated 10 times. At the same time, the researchers will place two small, damp sponges on the head of the participant. These sponges connect to the tDCS device, which sends a gentle current to your brain. It might feel a tingling sensation at first, but it will fade away. HIIT with a sham (inactive) neuromodulation: This is similar to the first program, but the tDCS device will only be active for a few minutes at the beginning and end of the session. HIIT alone: This involves just the cycling exercise with no brain stimulation. Who Can Participate? The researchers are looking for women who: Are 18-65 years old and have been diagnosed with fibromyalgia Experience moderate to high levels of pain Have stable blood pressure (if they have hypertension) Are not regularly active (don't do more than 30 minutes of exercise at least 3 times per week) What Will the Study involve? The participant will: Attend 6 conditioning sessions (cycling) over two weeks to prepare their body. Complete 4 weeks of HIIT training, three times per week, at Universidad Andres Bello. Attend 3 assessment sessions in our lab: before the conditioning, before the training, and after the training. These will include: Non-invasive tests to measure your physical fitness, muscle strength, and pain sensitivity Brain and muscle connection tests. Questionnaires about your sleep, pain, fatigue, anxiety, depression, and exercise enjoyment What the participant will get? At the end of the study in addition to the training benefits, participants will receive a detailed report showing their body composition (muscle and fat levels) before and after the training.
Interventions
OTHEREXERCISE TRAINING WITH OR WITHOUT MEDICATION
HIIT training: The participants will perform a HIIT protocol that consists of 1 minute of cycling at 50-60 revolutions per minute with a load that generates an effort of 80%-95% of their maximum Heart Rate (HR). Then 2 minutes of passive recovery, all this repeated 10 times (1x2x10). The effort of the session will be monitored by rating the perceived exertion (RPE) with a scale from 6-20 and HR. If the participant fails to recover within 2 minutes (\>70% maximum heart rate), resting time will be extended until an HR ≤ 70% of the maximum is achieved. The maximum HR of each session will be used for HIIT prescription for the next session.
OTHERNeuromodulators
Active tDCS: Two electrodes covered by a damp sponge will be placed on the scalp. The active electrode (anode) will be placed on the left motor cortex and the cathode on the contralateral supraorbital area before the exercise starts. The stimulation will start at the same time as the exercise, with an intensity of 2mA for 20 minutes.
Sponsors
Universidad Nacional Andres Bello
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants from tDCS (active) and sham tDCS (inactive) groups will be blinded to the stimulation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women with a diagnosis of Fibromyalgia by a physician according to the criteria of the American College of Rheumatology (ACR) 2016 * A stable medical treatment for symptoms for at least 4 weeks before participation (stable doses of medication) * Reported pain equal to or higher than 40 mm on the visual analogue scale (moderate or severe pain) for more than 3 months * Body mass index (BMI) between 18.5 and 39.9 kg m-2, * Controlled high blood pressure.
Exclusion criteria
* Isolated inflammatory joint, cancer, infectious, traumatic, localised neuropathic or degenerative joint pain. * Intense headache, cerebral surgery, seizure/epilepsy, cardiovascular, lung, metabolic (II diabetes mellitus), retinopathy or neurological diseases (i.e. stroke and traumatic brain injury antecedents), * Severe psychiatric disorders, major depression * Substance abuse. * Currently pregnant/breastfeeding, * Under physical therapy treatment or have participated in a designed sports or exercise training in systematic programs in the last 3 months. * Unable to speak or read Spanish fluently (inability to understand the pain scale and cooperate in testing)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of the numeric rating scale (0-10) for pain severity | Participants will be asked to rate their pain sensation at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The primary outcome is the auto reported rating of pain severity with a numeric rating scale from 0 to 10 points. Commonly used to assess pain severity, where zero means no pain and 10 means the worst pain imaginable. Participants will be asked to rate their pain sensation before and after the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sleep quality | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The sleep quality will be measured with: Numeric Rating Scale (0-10): single-item tool that instructs the patient to describe the quality of sleep during the past 24 hours, where 0 is the best possible sleep and 10 is the worst possible sleep. |
| Changes in the level of depression | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | Depression will be assessed with two the subitem for depression of the Fibromyalgia Impact Questionnaire (FIQR). This goes from 0 to 10 in an 11-point rating scale with higher scores representing severity. |
| Changes in quality of life | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | Quality of life will be assessed with the Fibromyalgia Impact Questionnaire (FIQR), which is a 21-item self-administered questionnaire. The questionnaire has 3 domains: function, overall impact and symptoms. The total score ranges from 0 to 100 points; higher scores indicate a severe impact. |
| Changes corticospinal excitability | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | To estimate corticospinal excitability peak-to-peak amplitude of the Motor Evoked Potential (MEP) will be measured. MEP is the response of the muscle to the stimulation of the corticomotor pathway with a magnetic stimulator and is measured with electromyography in milliAmpere (mA). |
| Adherence to training | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The adherence to exercise will be measured by the Exercise Attitude Questionnaire. The score is 1 point strongly disagree, 2 points somewhat disagree, 3 points somewhat agree, 4 points strongly agree. The total score is 72 points, and the cut-off point for adherence is \>60 points |
| Physical Activity | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | Physical Activity Readiness Questionnaire (PAR-Q): pre-participation screening tool for detection of possible health and cardiovascular problems. Include seven health-related questions to be answered yes or no. If the answer is yes to one question, the participant should talk to a physician before starting physical activity. If all questions are yes, the participant is fit to perform physical activity. |
| Maximal voluntary isometric contraction | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | It is the maximal voluntary effort of isometric contraction. The strength of the quadriceps will be evaluated during 3 trials using an isokinetic dynamometer (Isoforce®). |
| Muscle endurance | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | A knee extension at 20% maximal voluntary contraction will be performed until exhaustion. Participants' perception of effort will be measured using the 15-point rating of perceived exertion (RPE) scale every 20 seconds of the time to exhaustion task. |
| Aerobic capacity | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The aerobic capacity will be measured during an incremental cycling test. During this test, will be determined the maximum oxygen consumption (VO2peak) and the production of maximum concentric power (POmax) |
| Pain Sensitivity | Participants will be asked to rate their pain sensation at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | Pressure will be applied at an increasing rate of 50 kPa per second with an algometer placed perpendicular over the skin until the sensation of pressure changes to pain also known as pain pressure threshold (PPT). |
| Changes in generalised perception of fatigue | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | Generalised Fatigue: is a profound and overwhelming, more severe, constant, and unpredictable than normal tiredness, not relieved by resting or sleep, not proportional to effort exerted, and disruptive in terms of motivation, activities, and cognition. The generalised fatigue will be assessed with: Multidimensional Fatigue Inventory (MFI). A questionnaire with 20 items divided into 5 domains: general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation. The score range is between 4 to 20 points; a higher score indicates a greater degree of fatigue. |
| Changes in the number of painful areas in the body | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The participant will report the number of painful areas of the body (upper, lower, or axial regions) over the last week. The total score is 19, where 1 region pain equals 1 point, divided by the left upper region, right upper region, axial region, left lower region and right lower region. |
| Changes in Active Motor Threshold | Participants will be assessed before (T0) and after (T1) the four-week intervention. | It is the lowest stimulus intensity of a transcranial magnetic stimulator to generate a motor evoked potential with a peak-to-peak amplitude of 200 microvolts in at least five out of 10 consecutive trials when the muscle is activated at 20% of the maximal voluntary contraction. |
| Changes in Resting Motor Threshold | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | It is the lowest stimulus intensity of a transcranial magnetic stimulator to generate a motor evoked potential with a peak-to-peak amplitude of 50 microvolts in at least five out of 10 consecutive trials when the muscle is at rest. |
| Changes in the silence period after the motor evoked potential | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | It is the temporary interruption of the electromyographic signal from a muscle following a motor evoked potential. It is considered a measure of the excitability mediated by gamma-aminobutyric acid receptors. It will be measured in milliseconds (ms) from the end of the motor evoked potential wave to the recovery of the signal to the basal averaged amplitude. |
| Changes in anxiety levels | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | Changes in anxiety will be assessed with the subitem that evaluates anxiety of the Fibromyalgia Impact Questionnaire (FIQR) with 11 blocks (0 to 10), where higher scores indicate a severe impact. |
| Level of enjoyment of exercise | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The enjoyment of exercise will be assessed with the Physical Activity Enjoyment Scale. This scale includes 16 items with a maximum score of 80 points. The rating scale ranges from 1 (dislike a lot) to 5 (enjoy a lot). |
| Level of muscle soreness | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The participants will be asked to sit and stand 3 times with their legs shoulder-width apart and bend their knees to 90°. The volunteer must rate the level of discomfort by marking a straight vertical line on the horizontal line of a 100 mm rating scale. Higher values indicate greater soreness. |
| Level of fear of movement | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The fear of movement will be assessed with the Tampa Scale for Kinesiophobia. A questionnaire of 17 questions, with a maximum of 68 points. Scores \> 37 points indicate high levels of kinesiophobia, and ˂ 37 points indicate low levels. |
| Changes in negative cognitions related to pain | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The catastrophization of pain will be assessed with a self-reported questionnaire designed to assess catastrophic thinking related to pain among adults. This Pain Catastrophizing Scale has 13 items, each describing a thought or feeling about pain. Each item is rated on a 5-point Likert scale from 0 to 4, with a maximal score of 52. Higher scores indicate high catastrophising. |
| Changes in body composition | Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | The weight and body composition in percentage of muscle, fat and water will be measured with a bioimpedanciometer (InBody 770). |
| Muscle soreness | Participants will be asked to rate their pain sensation at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1). | To quantify the muscle soreness, the participants must mark with a straight vertical line on the horizontal line (from 0 to 100 millimetres), after performing a task of sitting and standing 3 times. |
Countries
Chile
Contacts
Primary ContactEdith Elgueta Cancino, PhD
Backup ContactOscar Nuñez Dias, Msc
Outcome results
None listed