FibromyalgiaNCT03801109
Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia
A study testing Hyperbaric group, Magnetic group and Physical group in people with Fibromyalgia, run by University of Valencia at 1 site in Spain.
Trial summary
Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Hyperbaric group, Magnetic group and Physical group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 26 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology of 1990.
- Having taken pharmacological treatment for more than three months without clinical improvement.
- Have the capacity to sign the informed consent form in accordance.
- Not having previously received treatment with a hyperbaric chamber or transcranial magnetic stimulation.
- Absence of other pathologies associated with the locomotor system at an advanced stage that makes physical activity impossible (arthritis, osteoarthritis, uric acid).
Who cannot join
- Pregnancy or lactation period.
- Epilepsy, drugs that lower the convulsive threshold, history of intense headaches, e endocranial and auditory elements, pathology related to the nervous system, either central or peripheral, not associated with fibromyalgia, endocranial hypertension.
- Hospital hypertension not controlled, heart and / or respiratory failure, cardiac pacemaker, pneumothorax.
- Claustrofobia and / or psychiatric pathologies; schizophrenia, bipolar disorder, psychosis.
- Patients with problems of alcohol addiction, psychoactive drugs or narcotics.
- Patients presenting neoplasia.
Show all 9Show fewer
- Surgical interventions of less than 4 months.
- Tympanic perforations.
- Cardiac slides.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effectiveness of Transcranial Magnetic Stimulation and the Hyperbaric Chamber in Women With Fibromyalgia. Randomized Clinical Trial.
Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms are back pain, headaches, irritable bowel, balance problems and deterioration of physical function in general. Patients with fibromyalgia (FM) often show pain at specific points that are known as "tender spots or tender spots, with an increased sensitivity to painful stimuli" (hyperalgesia) and a decreased pain threshold (allodynia). which can be evidenced in the physical examination and in the absence of anomalies that justify in the biological or image tests. These pain points to pressure, based on the most specific and specific criteria for the diagnosis of the disease, traditionally based on the criteria of the American College of Rheumatology (ACR), according to which, should be presented so minus 11 out of 18 painful points to confirm it. Although the etiology remains unknown and unclear, its appearance is attributed to a problem of central sensitization, that is, changes in central processing, which causes an alteration of the mechanisms that regulate the sensation of pain, with amplification of nociceptive input . and perpetuation of painful stimuli. Fibromyalgia is becoming a common syndrome in the countries of Western Europe, with a prevalence in the general population that ranges between 1-3%, and specifically in Spain, around 2.4%. In addition, it has a higher incidence in women than men (73-95%), predominantly affecting women between the ages of 40-50 years. About 3% of women with fibromyalgia are at an age when menopause occurs, so not only do they experience the symptoms of both states but they even exacerbate the syndrome with each other. On the other hand, and in relation to its chronicity, the care of this type of patients involves large costs for society with a significant consumption of health resources in the field of primary care, as well as the costs of work absenteeism. For these reasons, it is considered an important problem with a great impact on the health system, and therefore more and more studies are being developed with the aim of better understanding the pathophysiology of this disease. The therapeutic approach includes low cost and easy access measures, such as physical exercise (EF) programs to improve the symptoms of FM. Physical exercise has positive effects directly on pain, joint and muscle stiffness, generalized sensitivity and fatigue, among others, and secondarily on cognitive disorders. Thus, the vast majority of studies focus on low-impact aerobic exercise, performed between 60% and 70% of the maximum heart rate two to three times a week. However, to date, there is no study that compares the effectiveness of physical exercise with other innovative therapeutic actions, such as transcranial magnetic stimulation (TMS), the hyperbaric chamber (HBOT), in parameters related to pain and quality of life. the life of patients with fibromyalgia. The general objective is the effectiveness of transcranial magnetic stimulation and the hyperbaric chamber in women with fibromyalgia. As specific objectives we propose:
To assess the effect of HBOT, TMS and EF on quality of life in women with fibromyalgia.
- Object the effect of HBOT, TMS and EF in cortical functioning.
- Evaluate the effect of HBOT, TMS and EF on fatigue.
- Evaluate the effect of HBOT, TMS and EF on psychological aspects, such as depression and anxiety.
- Evaluate the effect of HBOT, TMS and EF on the perception of pain and the number of painful points.
- Evaluate the effect of HBOT, TMS and EF on the quality of sleep.
- Evaluate the effect of HBOT, TMS and EF on the quality of life.
- Evaluate the effect of HBOT, TMS and EF on the pain constructs.
- Determine the effect of HBOT, TMS and EF on plasma endorphin levels.
- Conditions
- Fibromyalgia
- Being tested
- Hyperbaric group, Magnetic group, Physical group, Baseline group
- Keywords
- transcranial magnetic stimulation, hyperbaric chamber, pain, endorphins
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric groupOther
Participants in this group performed 5 sessions per week for 8 weeks (40 sessions in total) . The time of each session is 90 minutes and the chamber pressure is 1.4 ATA with a 100% oxygen mask.
Magnetic groupOther
There will be 5 sessions per week for 2 consecutive weeks (10 sessions in total), stimulating the left motor cortex at high frequencies, 10 Hz, for 30 minutes.
Physical groupOther
A protocol of low-impact physical exercise will be performed twice a week for 8 weeks, with a total of 16 sessions.
Baseline groupOther
This group will be the control group that did not take any action, perform the activities of daily life
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric group | Experimental | Not described Receives: Other: Hyperbaric group |
| Magnetic group | Experimental | Not described Receives: Other: Magnetic group |
| Physical group | Active comparator | Not described Receives: Other: Physical group; Other: Baseline group |
| Baseline group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain intensity
Analog visual scale
Measured: Hyperbaric, Physical and Baseline groups: change from baseline in the intensity of pain at 8 weeks. Magnetic group: change from baseline in the intensity of pain at 3 weeks.
Secondary outcomes (14)
Rating of pain
The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. Interpretation : 0 minimum pain score and 78 maximum pain score. The higher the pain score the greater the pain.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Pain catastrophizing
it will be measurde by pain catastrophizing scale. It is a Self-administered scale on a 5-point Likert scale ranging from 0 (never) to 4 (always), which are distributed in 3 subscales: rumination (refers to a state or feeling of constant worry and the inability to inhibit thoughts related to pain), despair (manifested when hope has been lost for achieving something, or because it disappears or because it gives off some physical and / or psychological aspect that is detrimental to health) and magnification (refers to the exaggeration of unpleasant situations of pain and expectations of negative consequences). Higher scores indicate higher levels of catastrophism.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Acceptance of pain
The Chronic Pain Acceptance Questionnaire (CPAQ) is a 20-item inventory designed to measure acceptance of pain. here are two principle factors measured by this questionnaire: activities engagement and pain willingness. All items are rated on a 0 (never true) to 6 (always true) scale. The maximum possible total score is 120, with a higher score indicating better acceptance
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Pain self perception
The Pain Self-Perception Scale (PSPS) is a 24-item questionnaire used to assess mental defeat in chronic pain patients. espondents are asked to indicate to what extent each of the 24 statements applied to their experience "during a recent episode of intense pain". These statements are to be rated on a 5-point scale (0 = "Not at all/Never," 1 = "Very little," 2 = "Moderately," 3 = "Strongly," 4 = "Very strongly"), generating a total score ranging from 0 to 96. a higher score indicating worst self perception
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Psychological inflexibility
The scale that will be used is the Psychological Inflexibility in Pain Scale. It is a 12-item scale designed to measure psychological inflexibility in pain patients.The items consisted of different statements that were considered to be related to chronic pain, psychological inflexibility, suffering and disability All of the items were rated on a 7-point Likert-type scale that ranged from "1=never true" to "7=always true", with higher scores indicating more psychological inflexibility.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Number of painful points
The sensitivity of the 18 trigger points originally defined in the diagnosis of Fibromyalgia will be studied by means of an FPX 25 algometer (Wagner Instruments, Greenwich, USA) that records the pain threshold experienced
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Quality of life: perceived well-being
SF-12 Satisfacción with life scale
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Quality of sleep
Epworth Sleepiness Scale: the instrument asks the researched subject, about the frequency (or probability) of falling asleep on a scale of increase that from 0 to 3, for eight different daily situations, that most people can be involved, in your daily life, although not necessarily every day.2 The score of the 8 situations is added to obtain a total number. A result between 0 and 9 is considered normal; while one between 10 and 24 indicates that the patient should be referred to a specialist.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Level of depression
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Higher punctuations meaning, Higher scores indicate that the degree of depression is more severe
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Level of stress
To assess the state of stress the scale will be used the perceived srtress scale. This scale is a self-report instrument that evaluates the level of stress perceived during the last month, consists of 14 items with a response format of a scale of five points (0 = never, 1 = almost never, 2 = from time to time). when, 3 = often, 4 = very often). The total score of the PSS is obtained by inverting the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0 = 4, 1 = 3, 2 = 2, 3 = 1 and 4 = 0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Level of anxiety
To assess the state of stress the scale will be used the Hospital Anxiety and Depression Scale, it is a self-applied questionnaire with 14 items, on a Likert scale of 0-3. Higher score, greater anxiety and depression.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Evoked motor potential
The evoked motor potential will be recorded in each subject through the Neuro-MEP-Micro EMG, with the Neuro-MEO.NETomega.3.7.3.7 software. and surface electrodes placed in the musculature of the first dorsal interosseous. In addition, after acquiring the resting motor threshold of each subject, we have obtained the motor power evoked at 120 and 140%, to calculate the ratio of the amplitude of the potential.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Motor threshold
The resting motor threshold is defined as the minimum signal strength that must be provided to have an evoked motor potential of at least 50 microvolts in 50% of the tests. In our study we used the software TMS_MTAT_2.0.1 to calculate by means of an algorithm which is the minimum intensity of each subject, in the first dorsal interosseous of the right hand. To obtain it, a stimulation of a simple puslo will be carried out using the neuro-MS / D magnetic stimulator. Placed in the motor cortex M1, at 45º orientation with respect to the midline.
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Plasma pain biomarkers.
Beta-endorphin concentrations (pg/mL) will be measured by Human β-EP(Beta-Endorphin) ELISA Kit. The concentration ofHumanβ-EPin the samples is then determined by comparing the optical density (OD) of the samples to the standard curve
Measured: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Feb 2019
- Primary completion23 Dec 2019
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Izquierdo Alventosa, PT, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801109
- Sponsor's protocol ID
- H1548771544856
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2018
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Munoz-Gomez E, Molla-Casanova S, Gimeno-Mallench L, Chrivella-Garrido J, Serra-Ano P. Effects of a low-pressure hyperbaric oxygen therapy on psychological constructs related to pain and quality of life in women with fibromyalgia: A randomized clinical trial. Med Clin (Barc). 2024 Jun 14;162(11):516-522. doi: 10.1016/j.medcli.2023.12.016. Epub 2024 Feb 20. English, Spanish.
PubMed 38383268Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Gimeno-Mallench L, Sempere-Rubio N, Serra-Ano P. Effectiveness of High-Frequency Transcranial Magnetic Stimulation and Physical Exercise in Women With Fibromyalgia: A Randomized Controlled Trial. Phys Ther. 2021 Oct 1;101(10):pzab159. doi: 10.1093/ptj/pzab159.
PubMed 34216139Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Gimeno-Mallench L, Sempere-Rubio N, Chirivella J, Serra-Ano P. Comparative study of the effectiveness of a low-pressure hyperbaric oxygen treatment and physical exercise in women with fibromyalgia: randomized clinical trial. Ther Adv Musculoskelet Dis. 2020 Jun 24;12:1759720X20930493. doi: 10.1177/1759720X20930493. eCollection 2020.
PubMed 32636943
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Transcranial Magnetic Stimulation and the Hyperbaric Chamber in Women With Fibromyalgia. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03801109
- Acronym / sponsor ID
- H1548771544856
- Conditions
- Fibromyalgia
- Keywords
- transcranial magnetic stimulation, hyperbaric chamber, pain, endorphins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms are back pain, headaches, irritable bowel, balance problems and deterioration of physical function in general. Patients with fibromyalgia (FM) often show pain at specific points that are known as "tender spots or tender spots, with an increased sensitivity to painful stimuli" (hyperalgesia) and a decreased pain threshold (allodynia). which can be evidenced in the physical examination and in the absence of anomalies that justify in the biological or image tests. These pain points to pressure, based on the most specific and specific criteria for the diagnosis of the disease, traditionally based on the criteria of the American College of Rheumatology (ACR), according to which, should be presented so minus 11 out of 18 painful points to confirm it. Although the etiology remains unknown and unclear, its appearance is attributed to a problem of central sensitization, that is, changes in central processing, which causes an alteration of the mechanisms that regulate the sensation of pain, with amplification of nociceptive input . and perpetuation of painful stimuli. Fibromyalgia is becoming a common syndrome in the countries of Western Europe, with a prevalence in the general population that ranges between 1-3%, and specifically in Spain, around 2.4%. In addition, it has a higher incidence in women than men (73-95%), predominantly affecting women between the ages of 40-50 years. About 3% of women with fibromyalgia are at an age when menopause occurs, so not only do they experience the symptoms of both states but they even exacerbate the syndrome with each other. On the other hand, and in relation to its chronicity, the care of this type of patients involves large costs for society with a significant consumption of health resources in the field of primary care, as well as the costs of work absenteeism. For these reasons, it is considered an important problem with a great impact on the health system, and therefore more and more studies are being developed with the aim of better understanding the pathophysiology of this disease. The therapeutic approach includes low cost and easy access measures, such as physical exercise (EF) programs to improve the symptoms of FM. Physical exercise has positive effects directly on pain, joint and muscle stiffness, generalized sensitivity and fatigue, among others, and secondarily on cognitive disorders. Thus, the vast majority of studies focus on low-impact aerobic exercise, performed between 60% and 70% of the maximum heart rate two to three times a week. However, to date, there is no study that compares the effectiveness of physical exercise with other innovative therapeutic actions, such as transcranial magnetic stimulation (TMS), the hyperbaric chamber (HBOT), in parameters related to pain and quality of life. the life of patients with fibromyalgia. The general objective is the effectiveness of transcranial magnetic stimulation and the hyperbaric chamber in women with fibromyalgia. As specific objectives we propose:
To assess the effect of HBOT, TMS and EF on quality of life in women with fibromyalgia.
- Object the effect of HBOT, TMS and EF in cortical functioning.
- Evaluate the effect of HBOT, TMS and EF on fatigue.
- Evaluate the effect of HBOT, TMS and EF on psychological aspects, such as depression and anxiety.
- Evaluate the effect of HBOT, TMS and EF on the perception of pain and the number of painful points.
- Evaluate the effect of HBOT, TMS and EF on the quality of sleep.
- Evaluate the effect of HBOT, TMS and EF on the quality of life.
- Evaluate the effect of HBOT, TMS and EF on the pain constructs.
- Determine the effect of HBOT, TMS and EF on plasma endorphin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric group | Experimental | Other: Hyperbaric group |
| Magnetic group | Experimental | Other: Magnetic group |
| Physical group | Active comparator | Other: Physical group, Other: Baseline group |
| Baseline group | No intervention | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology of 1990.
- Having taken pharmacological treatment for more than three months without clinical improvement.
- Have the capacity to sign the informed consent form in accordance.
- Not having previously received treatment with a hyperbaric chamber or transcranial magnetic stimulation.
- Absence of other pathologies associated with the locomotor system at an advanced stage that makes physical activity impossible (arthritis, osteoarthritis, uric acid).
Key exclusion criteria (9 listed)
- Pregnancy or lactation period.
- Epilepsy, drugs that lower the convulsive threshold, history of intense headaches, e endocranial and auditory elements, pathology related to the nervous system, either central or peripheral, not associated with fibromyalgia, endocranial hypertension.
- Hospital hypertension not controlled, heart and / or respiratory failure, cardiac pacemaker, pneumothorax.
- Claustrofobia and / or psychiatric pathologies; schizophrenia, bipolar disorder, psychosis.
- Patients with problems of alcohol addiction, psychoactive drugs or narcotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric groupParticipants in this group performed 5 sessions per week for 8 weeks (40 sessions in total) . The time of each session is 90 minutes and the chamber pressure is 1.4 ATA with a 100% oxygen mask. | Other | Hyperbaric group |
| Magnetic groupThere will be 5 sessions per week for 2 consecutive weeks (10 sessions in total), stimulating the left motor cortex at high frequencies, 10 Hz, for 30 minutes. | Other | Magnetic group |
| Physical groupA protocol of low-impact physical exercise will be performed twice a week for 8 weeks, with a total of 16 sessions. | Other | Physical group |
| Baseline groupThis group will be the control group that did not take any action, perform the activities of daily life | Other | Physical group |
Primary outcome
Changes in pain intensity
Time frame: Hyperbaric, Physical and Baseline groups: change from baseline in the intensity of pain at 8 weeks. Magnetic group: change from baseline in the intensity of pain at 3 weeks.
Analog visual scale
14 secondary outcomes
Rating of pain
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Pain catastrophizing
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Acceptance of pain
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Pain self perception
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Psychological inflexibility
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Number of painful points
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Quality of life: perceived well-being
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Quality of sleep
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Level of depression
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Level of stress
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Level of anxiety
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Evoked motor potential
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Motor threshold
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Plasma pain biomarkers.
Time frame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 38383268Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Munoz-Gomez E, Molla-Casanova S, Gimeno-Mallench L, Chrivella-Garrido J, Serra-Ano P. Effects of a low-pressure hyperbaric oxygen therapy on psychological constructs related to pain and quality of life in women with fibromyalgia: A randomized clinical trial. Med Clin (Barc). 2024 Jun 14;162(11):516-522. doi: 10.1016/j.medcli.2023.12.016. Epub 2024 Feb 20. English, Spanish.
- Derived from this study: PubMed 34216139Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Gimeno-Mallench L, Sempere-Rubio N, Serra-Ano P. Effectiveness of High-Frequency Transcranial Magnetic Stimulation and Physical Exercise in Women With Fibromyalgia: A Randomized Controlled Trial. Phys Ther. 2021 Oct 1;101(10):pzab159. doi: 10.1093/ptj/pzab159.
- Derived from this study: PubMed 32636943Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Gimeno-Mallench L, Sempere-Rubio N, Chirivella J, Serra-Ano P. Comparative study of the effectiveness of a low-pressure hyperbaric oxygen treatment and physical exercise in women with fibromyalgia: randomized clinical trial. Ther Adv Musculoskelet Dis. 2020 Jun 24;12:1759720X20930493. doi: 10.1177/1759720X20930493. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Izquierdo Alventosa, PT principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric group, Magnetic group and Physical group in people with Fibromyalgia, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity (time frame: Hyperbaric, Physical and Baseline groups: change from baseline in the intensity of pain at 8 weeks. Magnetic group: change from baseline in the intensity of pain at 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801109, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.