FibromyalgiaNCT07872345
Alternative Treatment in Fibromyalgia
A study testing Neuroscience Pain Education and Therapeutic Exercise in people with Fibromyalgia and Fibromyalgia Syndrome, run by University of Alcala at 1 site in Spain.
Trial summary
The goal of this randomized control trial is to know evaluate the effects of a therapeutic exercise protocol with one programme based in pain neuroscience education as a treatment in fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Fibromyalgia Syndrome
- What is being tested?
- Neuroscience Pain Education and Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 8 Sep 2026
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with diagnosis in fibromyalgia
- Women with age over 18 and up to 80 years old.
Who cannot join
- no speak spanish well
- other active pathologies
Trial locations and contacts
1 site in 1 country.
Spain1 site
AMPAF YFC - Asociación Mirandesa de Personas Afectadas de Fibromialgia Y Fatiga Crónica
Miranda de Ebro, BURGOS, 09200
About this study
Official title: Effectiveness of Pain Neuroscience Education and Therapeutic Exercise as a Treatment of Fibromyalgia: A Randomized Clinical Trial
The goal of this randomized control trial is to know evaluate the effects of a therapeutic exercise protocol with one programme based in pain neuroscience education as a treatment in fibromyalgia.
The main question it aims to answer are: if the treatment is effective on reduction in pain, kinesiophobia, catastrofism, impact of fibromyalgia, in short term (at the final of interventions) and follow-up at 3 months, 6 months and a year after.
Participants will be alocated in two diferents groups: experimental and control. The experimental group is going to do therapeutic exercise and pain neuroscience education and the control group is going to do only therapeutic exercise.
Read the detailed description
Outcomes: pain (VAS/NPRS), impact of fibromyalgia (FIQ), Kinesiophobia (TAMPA-K scale), catastrofism (PCS).
- Conditions
- Fibromyalgia, Fibromyalgia Syndrome
- Being tested
- Neuroscience Pain Education, Therapeutic Exercise
- Keywords
- Neuroscience Pain Education, Therapeutic exercise
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroscience Pain EducationOther
Also called education
NPE are being dessigned as show the book Explain Pain with 7 theorical lessons.
Therapeutic ExerciseOther
Also called exercise
Participants must do therapeutic exercise based on strength, coordination, stability and balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Neuroscience Pain Education + therapeutic exercise | Experimental | 7 sesions of neuroscience pain education in 8 weeks (with one rest week). Also, all participants are going to do therapeutic exercise two hours per week during 8 weeks. Receives: Other: Neuroscience Pain Education; Other: Therapeutic Exercise |
| therapeutic exercise | Active comparator | all participants are going to do therapeutic exercise two hours per week during 8 weeks. Receives: Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Fibromyalgia (Fibromyalgia Impact Questionnaire)
The impact of fibromyalgia on participants, specifically assessing pain, sleep quality, rest quality, depression, and anxiety. Additionally, participants will be asked about the number of daily activities they performed during the past week. This questionnaire yields a total score ranging from 0 to 100.
Measured: baseline, up to 3 months, up to 6 months
Intensity of pain (Numerical Pain Rating Scale)
with Numerical Pain Rating Scale (NPRS) to measure the quantify of the pain in several parts of the day. This scale yields a total score ranging from 0 to 100.
It is a scale consisting of a horizontal straight line of fixed length, usually 100 mm. The extremes are defined as the extreme limits of the parameter to be measured (symptom, pain, health) oriented from left (worst) to right (best).
Measured: baseline, up to 3 months, up to 6 months
Secondary outcomes (3)
TAMPA SCALE OF KINESIOPHOBIA (TSK-11) Level of kinesiophobia
The assessment of kinesiophobia (fear of movement or re-injury) using the shortened Tampa Scale for Kinesiophobia (TSK-11). This self-report questionnaire consists of 11 items scored on a 4-point Likert scale. Total scores range from 11 to 44, where higher scores indicate greater levels of kinesiophobia and movement-related fear.
Measured: baseline, up to 3 months, up to 6 months
pain catastrophizing using the Pain Catastrophizing Scale (PCS)
The assessment of pain catastrophizing using the Pain Catastrophizing Scale (PCS). This self-report questionnaire consists of 13 items scored on a 5-point Likert scale. Total scores range from 0 to 52, where higher scores indicate greater levels of pain-related catastrophizing, rumination, helplessness, and magnification.
Measured: baseline, up to 3 months, up to 6 months
multidimensional pain quality and intensity using the Short-Form McGill Pain Questionnaire (SF-MPQ)
The assessment of multidimensional pain quality and intensity using the Short-Form McGill Pain Questionnaire (SF-MPQ). This instrument consists of 15 pain descriptors: 11 sensory items (subscore range: 0-33) and 4 affective items (subscore range: 0-12), each rated on a 4-point Likert scale from 0 ("none") to 3 ("severe"), yielding a Total Pain Rating Index ranging from 0 to 45. Additionally, it includes a 10-cm Visual Analogue Scale (VAS) for overall pain intensity and the 6-point Present Pain Intensity (PPI) index. Higher scores across all components indicate a more severe pain experience.
Measured: baseline, up to 3 months, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Sep 2025
- Primary completion30 Mar 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Cerezo-Téllez, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872345
- Sponsor's protocol ID
- ECA cuantitativo FM
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neuroscience Education and Therapeutic Exercise as a Treatment of Fibromyalgia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07872345
- Acronym / sponsor ID
- ECA cuantitativo FM
- Conditions
- Fibromyalgia, Fibromyalgia Syndrome
- Keywords
- Neuroscience Pain Education, Therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 13 Oct 2026 (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.
The goal of this randomized control trial is to know evaluate the effects of a therapeutic exercise protocol with one programme based in pain neuroscience education as a treatment in fibromyalgia.
The main question it aims to answer are: if the treatment is effective on reduction in pain, kinesiophobia, catastrofism, impact of fibromyalgia, in short term (at the final of interventions) and follow-up at 3 months, 6 months and a year after.
Participants will be alocated in two diferents groups: experimental and control. The experimental group is going to do therapeutic exercise and pain neuroscience education and the control group is going to do only therapeutic exercise.
Detailed description
Outcomes: pain (VAS/NPRS), impact of fibromyalgia (FIQ), Kinesiophobia (TAMPA-K scale), catastrofism (PCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuroscience Pain Education + therapeutic exercise | Experimental | Other: Neuroscience Pain Education, Other: Therapeutic Exercise7 sesions of neuroscience pain education in 8 weeks (with one rest week). Also, all participants are going to do therapeutic exercise two hours per week during 8 weeks. |
| therapeutic exercise | Active comparator | Other: Therapeutic Exerciseall participants are going to do therapeutic exercise two hours per week during 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with diagnosis in fibromyalgia
- Women with age over 18 and up to 80 years old.
Key exclusion criteria (2 listed)
- no speak spanish well
- other active pathologies
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 |
|---|---|---|
| Neuroscience Pain EducationAlso: educationNPE are being dessigned as show the book Explain Pain with 7 theorical lessons. | Other | Neuroscience Pain Education + therapeutic exercise |
| Therapeutic ExerciseAlso: exerciseParticipants must do therapeutic exercise based on strength, coordination, stability and balance exercises. | Other | Neuroscience Pain Education + therapeutic exercise, therapeutic exercise |
Primary outcome
Impact of Fibromyalgia (Fibromyalgia Impact Questionnaire)
Time frame: baseline, up to 3 months, up to 6 months
The impact of fibromyalgia on participants, specifically assessing pain, sleep quality, rest quality, depression, and anxiety. Additionally, participants will be asked about the number of daily activities they performed during the past week. This questionnaire yields a total score ranging from 0 to 100.
Intensity of pain (Numerical Pain Rating Scale)
Time frame: baseline, up to 3 months, up to 6 months
with Numerical Pain Rating Scale (NPRS) to measure the quantify of the pain in several parts of the day. This scale yields a total score ranging from 0 to 100. It is a scale consisting of a horizontal straight line of fixed length, usually 100 mm. The extremes are defined as the extreme limits of the parameter to be measured (symptom, pain, health) oriented from left (worst) to right (best).
3 secondary outcomes
TAMPA SCALE OF KINESIOPHOBIA (TSK-11) Level of kinesiophobia
Time frame: baseline, up to 3 months, up to 6 months
pain catastrophizing using the Pain Catastrophizing Scale (PCS)
Time frame: baseline, up to 3 months, up to 6 months
multidimensional pain quality and intensity using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: baseline, up to 3 months, up to 6 months
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroscience Pain Education and Therapeutic Exercise in people with Fibromyalgia and Fibromyalgia Syndrome, run by University of Alcala 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 2 inclusion and 2 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 13 Oct 2026. 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?
Impact of Fibromyalgia (Fibromyalgia Impact Questionnaire) (time frame: baseline, up to 3 months, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.