AzTrials
AzTrials

FibromyalgiaPNE-ST-FMNCT04855851

Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia

A study testing PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING in people with Fibromyalgia, run by Manuel Rebollo Salas at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibromyalgia
What is being tested?
PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
1 Mar 2022to 15 Aug 2025
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 20 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

    Seville, Spain, 41009

Other trials in Spain

About this study

Official title: Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia

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.

Read the 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.

Conditions
Fibromyalgia
Being tested
PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING, USUAL CARE
Keywords
Fibromyalgia, Education, Strength training
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAININGProcedure or surgery

    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.

  • USUAL CAREProcedure or surgery

    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.

Study groups in NCT04855851
Study groupRoleWhat they receive
PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAININGExperimentalSubjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE) sessions and 12 weeks (3 times/week) of STRENGTH TRAINING (ST)
Receives: Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
USUAL CAREActive comparatorThe subjects of this group will receive Usual Care. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients, and recommendation of aerobic and flexibility exercise
Receives: Procedure: USUAL CARE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Self-report Pain Intensity

    Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity

    Measured: 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).

  2. Change from Central Sensitization symptoms

    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.

    Measured: 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)

  3. Change from Disability

    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.

    Measured: 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)

Secondary outcomes (5)

  1. Change from viscoelastic properties.

    Measured by the Myoton®.

    Measured: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]

  2. Change from Autonomic Disfunction symptoms

    Measured by the Heart Rate Variability.

    Measured: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]

  3. Change from Nerve Conduction Velocity

    Measured by the Sensory Nerve Action Potential (SNAP).

    Measured: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]

  4. Change from grip strength

    Measure by the dynamometer.

    Measured: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]

  5. Change from the pressure pain threshold

    Measure by the pressure algometer.

    Measured: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start1 Mar 2022
  3. Primary completion30 Dec 2023
  4. Study completion15 Aug 2025

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04855851
Sponsor's protocol ID
USeville-AJRD
Acronym
PNE-ST-FM
Status last verified
Aug 2025
First submitted
16 Apr 2021
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Andrade A, de Azevedo Klumb Steffens R, Sieczkowska SM, Peyre Tartaruga LA, Torres Vilarino G. A systematic review of the effects of strength training in patients with fibromyalgia: clinical outcomes and design considerations. Adv Rheumatol. 2018 Oct 22;58(1):36. doi: 10.1186/s42358-018-0033-9.

    PubMed 30657077

  • Serrat M, Sanabria-Mazo JP, Garcia-Troiteiro E, Fontcuberta A, Mateo-Canedo C, Almirall M, Feliu-Soler A, Mendez-Ulrich JL, Sanz A, Luciano JV. Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Jan 19;17(2):634. doi: 10.3390/ijerph17020634.

    PubMed 31963773

  • Nelson NL. Muscle strengthening activities and fibromyalgia: a review of pain and strength outcomes. J Bodyw Mov Ther. 2015 Apr;19(2):370-6. doi: 10.1016/j.jbmt.2014.08.007. Epub 2014 Aug 19.

    PubMed 25892394

  • Barrenengoa-Cuadra MJ, Angon-Puras LA, Moscosio-Cuevas JI, Gonzalez-Lama J, Fernandez-Luco M, Gracia-Ballarin R. [Effectiveness of pain neuroscience education in patients with fibromyalgia: Structured group intervention in Primary Care]. Aten Primaria. 2021 Jan;53(1):19-26. doi: 10.1016/j.aprim.2019.10.007. Epub 2020 Feb 6. Spanish.

    PubMed 32033824

  • Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

    PubMed 22133255

  • Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.

    PubMed 27377815

  • Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.

    PubMed 33024295

  • Marques AP, Santo ASDE, Berssaneti AA, Matsutani LA, Yuan SLK. Prevalence of fibromyalgia: literature review update. Rev Bras Reumatol Engl Ed. 2017 Jul-Aug;57(4):356-363. doi: 10.1016/j.rbre.2017.01.005. Epub 2017 Feb 8. English, Portuguese.

    PubMed 28743363

  • Cabo-Meseguer A, Cerda-Olmedo G, Trillo-Mata JL. Fibromyalgia: Prevalence, epidemiologic profiles and economic costs. Med Clin (Barc). 2017 Nov 22;149(10):441-448. doi: 10.1016/j.medcli.2017.06.008. Epub 2017 Jul 19. English, Spanish.

    PubMed 28734619

  • Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14.

    PubMed 18191990

  • Nijs J, Van Houdenhove B. From acute musculoskeletal pain to chronic widespread pain and fibromyalgia: application of pain neurophysiology in manual therapy practice. Man Ther. 2009 Feb;14(1):3-12. doi: 10.1016/j.math.2008.03.001. Epub 2008 Jun 3.

    PubMed 18511329

  • Cagnie B, Coppieters I, Denecker S, Six J, Danneels L, Meeus M. Central sensitization in fibromyalgia? A systematic review on structural and functional brain MRI. Semin Arthritis Rheum. 2014 Aug;44(1):68-75. doi: 10.1016/j.semarthrit.2014.01.001. Epub 2014 Jan 8.

    PubMed 24508406

  • Feliu-Soler A, Borras X, Penarrubia-Maria MT, Rozadilla-Sacanell A, D'Amico F, Moss-Morris R, Howard MA, Fayed N, Soriano-Mas C, Puebla-Guedea M, Serrano-Blanco A, Perez-Aranda A, Tuccillo R, Luciano JV. Cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study). BMC Complement Altern Med. 2016 Feb 27;16:81. doi: 10.1186/s12906-016-1068-2.

    PubMed 26921267

  • Assumpcao A, Matsutani LA, Yuan SL, Santo AS, Sauer J, Mango P, Marques AP. Muscle stretching exercises and resistance training in fibromyalgia: which is better? A three-arm randomized controlled trial. Eur J Phys Rehabil Med. 2018 Oct;54(5):663-670. doi: 10.23736/S1973-9087.17.04876-6. Epub 2017 Nov 29.

    PubMed 29185675

  • American College of Sports Medicine Position Stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc. 1998 Jun;30(6):975-91. doi: 10.1097/00005768-199806000-00032.

    PubMed 9624661

Questions about this trial

What is this clinical trial studying?

A study testing PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING in people with Fibromyalgia, run by Manuel Rebollo Salas 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 6 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 Aug 2025. 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?

Change from Self-report Pain Intensity (time frame: 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).). The study lists 3 primary outcomes in all. 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 NCT04855851, which also lists 16 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 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in