Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed with Spondyloarthritis
NCT ID: NCT06369324
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2024-02-15
2024-04-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Management strategies encompass a multidisciplinary approach, with physiotherapy emerging as a cornerstone therapeutic modality. Various exercise interventions, particularly those supervised by trained professionals, demonstrate efficacy in improving pain, stiffness, and overall functional capacity. Furthermore, patient education plays a pivotal role in enhancing treatment adherence and optimizing outcomes by aligning patient expectations with therapeutic goals.
The evolving landscape of spondyloarthritis management underscores the necessity of further research into multimodal treatment approaches, particularly in integrating novel interventions such as electrophysical agents. By elucidating the mechanisms of action and exploring their synergistic effects, clinicians can refine treatment protocols and ultimately enhance the quality of care provided to individuals living with spondyloarthritis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pain Neuroscience Education in Chronic Musculoskeletal Pain
NCT03100721
Neuroscience Education in Shoulder Pain: Clinical Trial
NCT06739694
Effectiveness of a Pain Neuroscience Education and Therapeutic Exercise Program Delivered by Primary Care Physiotherapists to Patients With Chronic Nociplastic Spinal Pain
NCT07133607
Impact of a Pain Neuroscience Education Program on Primary Students with and Without Intellectual Disabilities
NCT06664606
Influence of a Educational Internet-based Intervention in Chronic Low Back Pain Patients: A Mixed Methods Approach
NCT02369120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In terms of clinical manifestations, early symptoms include back pain and stiffness. Over time, AS can fuse vertebrae and limit movement, causing severe and constant pain. Diagnosis and follow-up of the disease is based on clinical history and physical examination. Radiological tests may also be used to complement the diagnosis. Over the years, the concept of spondyloarthropathy has evolved, and is now defined as a combination of axial spondyloarthritis (SpA), psoriatic arthritis (PsA) and inflammatory bowel disease (IBD).
With regard to the criteria according to the Assessment of Spondyloarthritis International Society (ASAS) and the latest update of the Clinical Practice Guideline for the treatment of SpA and psoriatic arthritis, within SpA the investigators find AD as the most representative pathology of this group, being the one the investigators will focus on in this research project.
The diagnosis of axial SpA requires: a) imaging evidence confirming sacroiliitis and b) at least one sign of SpA or HLA-B27 marker and two of the signs determined according to ASAS (inflammatory low back pain, arthritis, enthesitis, uveitis, dactylitis, psoriasis, Crohn's disease, good response to NSAIDs, family history of SpA, presence of HLA-B27 antigen or presence of increased C-reactive protein). In this regard, in addition to imaging and laboratory tests, the International Society for the Evaluation of SpA classification considers common clinical features as the main diagnostic axis.
Based on the latest SER review, the mechanism by which the disease occurs is still not entirely clear, although there is a genetic predisposition. Among the factors involved, the most important is the presence of the positive HLA-B27 antigen, which is present in the vast majority of patients with AD and less frequently in the rest of the diseases of the SpA group. Taking into account that only 10% of HLA-B27 antigen carriers will present with the disease, it is essential to present clinical signs to support the diagnosis.
According to the best available scientific evidence, physiotherapy is the main effective rehabilitation treatment measure for patients with SpA, and specifically for the most widespread form of the disease such as AD.
Several rehabilitation modalities exist, although, to date, there is limited consensus on a sequenced and standardised protocol. The review analysed 28 studies in which at least one intervention group received physiotherapy treatment. A total of 1926 subjects with AS were analysed, with pain, stiffness, mobility (spine and chest wall) and physical function (disease activity, ABVD and global function) being the main variables studied.
The results reported that doing physiotherapy through therapeutic exercise performed by physiotherapists is better than doing nothing. Within the exercise modalities, supervised exercise by external control or focus is showing better results in regulating pain modulatory mechanisms, also improving pain intensity, range of motion and perceived disability in subjects with spinal pathology.
On the other hand, electrophysical agents have also been routinely applied in subjects with spinal pathology, as they are inexpensive procedures with no reported adverse effects and can be easily accessible to the general population. Among these, transcutaneous electrical stimulation procedures with TENS-type currents stand out. This modality is applied via adhesive electrodes placed on the skin or on the affected nerve in question, as well as those that use medium-frequency interferential currents, showing clinical efficacy in reducing perceived pain. However, there are limited studies that apply these interventions in subjects diagnosed with AD, and as far as the authors of this project are aware, there are no clinical trials that analyse the effects of combining both interventions in a multimodal programme.
On the other hand, there are studies that demonstrate the importance of satisfaction as an influential factor in both the clinical benefits and the quality of the health care provided. If the investigators focus exclusively on the field of physiotherapy, similar benefits have been reported between those who receive an educational briefing and those who receive a standardised physiotherapy treatment without adequate information. Accurate information about the disease in question and about the stages of treatment will therefore ensure that the user's expectations are in line with reality, favouring overall satisfaction and adherence to treatment.
In this context, there has been a growing interest in analysing multimodal physiotherapy programmes in the approach to chronic musculoskeletal pathology.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
Participants in the control group will not receive any intervention and will continue with their normal combat and flight exercise activities. They will be asked not to take medication or seek alternative treatments.
No interventions assigned to this group
Intervention group
Participants in the intervention group will follow a programme of education in pain neuroscience, supervised therapeutic exercise, and an intervention based on manual therapy combined with electrical stimulation called electro-massage.
Pain education
It consisted of holding information sessions on each of the days that the subjects were scheduled for treatment. These sessions will be supported by supplementary material in the form of brochures, posters and videos which briefly explain interesting knowledge about spondyloarthropathies.
Exercise supervised by external focus
This therapeutic exercise involves proprioceptive training with external feedback to enhance exercise execution and promote optimal postural control, particularly for individuals with back pain. The method, based on research by Abdollahipour et al. and Chiviacowsky et al., focuses on automatic control, reducing the cognitive load during exercises and improving movement retention. The Motion Guidance Clinician Kit will be utilized, consisting of a panel and laser guide for precise cervical movement. Exercises progress in difficulty over 12 sessions, targeting cervical and lumbopelvic stabilization, flexion-extension, rotations, and lateral flexions. Sessions start with seated exercises and progress to standing, with increasing distance between laser targets to expand cervical range of motion. Thoracic and lumbar exercises involve 10 repetitions each. The entire program lasts around 20 minutes and follows Tidier recommendations for intervention.
Therapy by means of electrical stimulation (electro-massage)
This technique combines manual therapy (massage) with interferential current. Following a supervised therapeutic exercise program, this intervention targets the spine for 15 minutes. Using a Sonopuls 692® device, a bipolar current mode with specific frequencies is applied. The physiotherapist moistens sponges with warm water and administers the current through them while performing manual soft tissue therapy on the neck, shoulders, scapulae, thoracic, lumbar, and sacral areas. The intensity is adjusted to provide a strong but comfortable tingling sensation, without muscle twitching. The therapy sequence includes superficial stroking, deep gliding movements, trapezius kneading, muscle stretching, and deep rubbing on the thoracic and lumbar areas. The electro-massage protocol lasts 14 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pain education
It consisted of holding information sessions on each of the days that the subjects were scheduled for treatment. These sessions will be supported by supplementary material in the form of brochures, posters and videos which briefly explain interesting knowledge about spondyloarthropathies.
Exercise supervised by external focus
This therapeutic exercise involves proprioceptive training with external feedback to enhance exercise execution and promote optimal postural control, particularly for individuals with back pain. The method, based on research by Abdollahipour et al. and Chiviacowsky et al., focuses on automatic control, reducing the cognitive load during exercises and improving movement retention. The Motion Guidance Clinician Kit will be utilized, consisting of a panel and laser guide for precise cervical movement. Exercises progress in difficulty over 12 sessions, targeting cervical and lumbopelvic stabilization, flexion-extension, rotations, and lateral flexions. Sessions start with seated exercises and progress to standing, with increasing distance between laser targets to expand cervical range of motion. Thoracic and lumbar exercises involve 10 repetitions each. The entire program lasts around 20 minutes and follows Tidier recommendations for intervention.
Therapy by means of electrical stimulation (electro-massage)
This technique combines manual therapy (massage) with interferential current. Following a supervised therapeutic exercise program, this intervention targets the spine for 15 minutes. Using a Sonopuls 692® device, a bipolar current mode with specific frequencies is applied. The physiotherapist moistens sponges with warm water and administers the current through them while performing manual soft tissue therapy on the neck, shoulders, scapulae, thoracic, lumbar, and sacral areas. The intensity is adjusted to provide a strong but comfortable tingling sensation, without muscle twitching. The therapy sequence includes superficial stroking, deep gliding movements, trapezius kneading, muscle stretching, and deep rubbing on the thoracic and lumbar areas. The electro-massage protocol lasts 14 minutes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with ankylosing spondylitis by a rheumatologist.
Exclusion Criteria
* Subjects with mild/moderate cognitive impairment (score ≥24 in the Spanish validated version for general older adults of the Mini-Mental State Examination) (Lobo A, Saz P, Marcos G et al. Revalidation and standardisation .
* Finally, those with pharmacological treatment that could generate vestibular or balance disturbances at the time of assessment and treatment.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Extremadura
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carlos Fernández-Morales
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luis Espejo-Antúnez, Ph.D
Role: STUDY_DIRECTOR
University of Extremadura
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Medicine and Health Sciences
Badajoz, Badajoz, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zao A, Cantista P. The role of land and aquatic exercise in ankylosing spondylitis: a systematic review. Rheumatol Int. 2017 Dec;37(12):1979-1990. doi: 10.1007/s00296-017-3829-8. Epub 2017 Oct 5.
Albornoz-Cabello M, Barrios-Quinta CJ, Espejo-Antunez L, Escobio-Prieto I, Casuso-Holgado MJ, Heredia-Rizo AM. Immediate clinical benefits of combining therapeutic exercise and interferential therapy in adults with chronic neck pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2021 Oct;57(5):767-774. doi: 10.23736/S1973-9087.21.06688-0. Epub 2021 Mar 24.
Albornoz-Cabello M, Sanchez-Santos JA, Melero-Suarez R, Heredia-Rizo AM, Espejo-Antunez L. Effects of Adding Interferential Therapy Electro-Massage to Usual Care after Surgery in Subacromial Pain Syndrome: A Randomized Clinical Trial. J Clin Med. 2019 Feb 2;8(2):175. doi: 10.3390/jcm8020175.
Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.
Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. doi: 10.1136/bmj.38216.868808.7C. Epub 2004 Sep 17.
Lara-Palomo IC, Aguilar-Ferrandiz ME, Mataran-Penarrocha GA, Saavedra-Hernandez M, Granero-Molina J, Fernandez-Sola C, Castro-Sanchez AM. Short-term effects of interferential current electro-massage in adults with chronic non-specific low back pain: a randomized controlled trial. Clin Rehabil. 2013 May;27(5):439-49. doi: 10.1177/0269215512460780. Epub 2012 Oct 3.
Navarro-Compan V, Sepriano A, El-Zorkany B, van der Heijde D. Axial spondyloarthritis. Ann Rheum Dis. 2021 Dec;80(12):1511-1521. doi: 10.1136/annrheumdis-2021-221035. Epub 2021 Oct 6.
Rudwaleit M, van der Heijde D, Landewe R, Akkoc N, Brandt J, Chou CT, Dougados M, Huang F, Gu J, Kirazli Y, Van den Bosch F, Olivieri I, Roussou E, Scarpato S, Sorensen IJ, Valle-Onate R, Weber U, Wei J, Sieper J. The Assessment of SpondyloArthritis International Society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general. Ann Rheum Dis. 2011 Jan;70(1):25-31. doi: 10.1136/ard.2010.133645. Epub 2010 Nov 24.
Sharan D, Rajkumar JS. Physiotherapy for Ankylosing Spondylitis: Systematic Review and a Proposed Rehabilitation Protocol. Curr Rheumatol Rev. 2017;13(2):121-125. doi: 10.2174/1573397112666161025112750.
van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361-8. doi: 10.1002/art.1780270401.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.