Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis

Ankylosing Spondylitis Clinical Trial

Official title:

Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369324
• Other study ID #: 05
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: April 11, 2024

Study information

• Verified date: April 2024
• Source: Universidad de Extremadura
• Contact: Luis Espejo-Antúnez, Ph.D
• Phone: 0034675685153
• Email: luisea[@]unex.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spondyloarthritis, notably ankylosing spondylitis (AS), represents a chronic rheumatic condition typified by persistent back pain and stiffness. It constitutes a substantial portion of diagnoses within rheumatology units and exhibits a higher prevalence among males. Diagnosis relies upon comprehensive clinical evaluation, including patient history, physical examination, and adjunctive radiological assessments, with genetic predisposition, particularly the presence of the HLA-B27 antigen, playing a significant role.

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.

Description:

Spondyloarthritis or ankylosing spondylitis (AS) is a type of chronic spondyloarthropathy. According to the Spanish Society of Rheumatology (SER), spondyloarthropathies constitute a heterogeneous family of interrelated rheumatic diseases that share clinical, pathogenic, genetic, radiological, epidemiological and therapeutic response characteristics. From an epidemiological point of view, they are increasingly frequent diseases, accounting for more than 13% of patients diagnosed in rheumatology units. Specifically, international reference studies place AD as the most frequent, with an estimated incidence of 7 new cases per 100,000 inhabitants per year. It is more frequent in men than in women (in a ratio of 3:1) and the age range is between 20 and 30 years. In Extremadura the incidence is no less. According to the National Institute of Statistics (INE), there are currently 24 cases per 1000 people diagnosed with rheumatoid arthritis or AD, and 55 cases per 1000 people diagnosed with arthritis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults (men and women) over 18-65 years of age.

• Diagnosed with ankylosing spondylitis by a rheumatologist.

Exclusion Criteria:

• Sample subjects with spinal surgery in the last 12 months were excluded.

• 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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Exercise Therapy
• Pain Management
• Physical Therapy Modalities
• Spondylarthritis
• Spondylarthropathies
• Spondylitis
• Spondylitis, Ankylosing
• Spondyloarthropathies

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Faculty of Medicine and Health Sciences	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	Numeric Pain Rating Scale (NPRS) is a 11-point numeric rating scale, where 0 denotes "no pain" and 10 denotes "the maximum bearable pain". The minimum clinically important difference (MCID) for this tool has been established at 1.5 points and the minimum detectable change (MDC) at 2.6 points, in individuals with neck pain. The NPRS is a valid scale with moderate test-retest reliability in this population (Intraclass Coefficient Correlation (ICC): 0.76, 95% CI 0.58 to 0.93).	4 weeks.
Primary	Cervical and Lumbar Joint Position Sense Error	This test consists of a visual measurement of the error when moving the head to the initial neutral position after active cervical rotation, or when performing lumbar flexion or extension and returning to a neutral position.	4 weeks.
Primary	Cervical Range of Motion (CRoM)	For the evaluation of CROM, a conventional EnrafNonius® two-branch goniometer was used. Subjects were placed in a seated position on a stool, with a neutral neck and head position. The range of active cervical mobility presented by the patients was measured in reference to the three planes of the space. In the sagittal plane, the degrees of mobility to flexion and extension were measured, in the frontal plane the right and left inclinations, and in the transverse plane both rotations.	4 weeks.
Primary	Pressure Pain Threshold (PPT)	A mechanical pressure Fisher algometer (Force Dial model FDK 40) with a 1 cm² area contact head was used to measure the pressure pain threshold. The reliability of pressure algometry has been found to be high [intraclass correlation coefficient = 0.91 (95% confidence interval, 0.82-0.97)]. With the participant in supine, the pressure pain threshold of the the myofascial trigger point nº2 of the upper trapezius muscle according to Travell and Simons and the central trigger point of the sternocleidomastoid muscle was bilaterally evaluated. Also, in sitting position the pressure pain threshold of the myofascial trigger point of the scapula elevator muscle was bilaterally evaluated. The minimal clinically important difference (MCDI) is 1.2 Kg/cm2.	4 weeks.
Primary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Is a questionnaire used to assess disease activity and severity in individuals with ankylosing spondylitis, focusing on symptoms such as pain, stiffness, and fatigue. The minimum score is 0 and the maximum score is 60. Higher scores indicate a worse outcome.	4 weeks.
Primary	Bath Ankylosing Spondylitis Motility Index (BASMI)	The Bath Ankylosing Spondylitis Motility Index (BASMI) explores the mobility of the spine and hips and includes the Schober test to indicate the degree of mobility of the lumbar tract. The minimum score is 0 and the maximum score is 10. Higher scores indicate a worse outcome.	4 weeks.
Primary	Bath Ankylosing Spondylitis Functional Index (BASFI).	The Bath Ankylosing Spondylitis Functional Index (BASFI) is a questionnaire used to evaluate the functional ability and physical functioning of individuals with ankylosing spondylitis. It assesses aspects such as activities of daily living, mobility, and overall function, providing a measure of disease impact on a person's life. The minimum score is 0 and the maximum score is 100. Higher scores indicate a worse outcome.	4 weeks.
Primary	Kinesophobia	The Spanish version of the TSK-11 was used to measure fear of movement. Higher scores indicate greater fear-avoidance behaviors. The TSK-11 has demonstrated acceptable internal consistency and validity.	4 weeks.
Primary	Catastrophizing Pain	The Pain Catastrophizing Scale (PCS) is a self-administered scale of 13 items and one of the most used to assess catastrophism of pain. The subjects take their past painful experiences as a reference and indicate the degree to which they experienced each of the 13 thoughts or feelings on a 5-point Líkert scale ranging from 0 (never) to 4 (always). The theoretical range of the instrument is between 13 and 62, indicating low scores, little catastrophism, and high values, high catastrophism.	4 weeks.
Primary	Fear-Avoidance Beliefs Questionnaire (FABQ)	The Fear-Avoidance Beliefs Questionnaire (FABQ) is a self-report measure designed to assess beliefs and attitudes related to fear of movement and avoidance behavior in individuals with musculoskeletal pain, particularly low back pain. It evaluates the extent to which individuals perceive physical activity as harmful and the degree to which they avoid certain activities due to fear of exacerbating their pain. The minimum score is 0 and the maximum score is 96. Higher scores indicate a worse outcome.	4 weeks.