An interventional study of Neuroscience Pain Education and Therapeutic Exercise in Fibromyalgia and Fibromyalgia Syndrome, sponsored by University of Alcala. Completed at 1 site in Spain. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of Alcala · Not applicable, Interventional, and Treatment
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.
Outcomes: pain (VAS/NPRS), impact of fibromyalgia (FIQ), Kinesiophobia (TAMPA-K scale), catastrofism (PCS).
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University of Alcala is the lead sponsor of 128 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Neuroscience Pain Education · Other: Therapeutic Exercise
all participants are going to do therapeutic exercise two hours per week during 8 weeks.
Other: Therapeutic Exercise
NPE are being dessigned as show the book Explain Pain with 7 theorical lessons.
Also known as: education
Participants must do therapeutic exercise based on strength, coordination, stability and balance exercises.
Also known as: exercise
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.
Time frame: 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).
Time frame: baseline, up to 3 months, up to 6 months
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.
Time frame: 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.
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)
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.
Time frame: baseline, up to 3 months, up to 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Mar 2026, 6 months.
Of 510 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 6 months is below that.
Counting every sponsor, half of 522 studies reached it within 13 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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