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

NCT06369324 | Completed

• 1 other identifier: 05
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spondyloarthropathies; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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.

Other: Pain education; Other: Exercise supervised by external focus; Other: Therapy by means of electrical stimulation (electro-massage)

Interventions

Pain education OTHER

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.

Intervention group

Exercise supervised by external focus OTHER

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.

Intervention group

Therapy by means of electrical stimulation (electro-massage) OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (men and women) over 18-65 years of age.
• Diagnosed with ankylosing spondylitis by a rheumatologist.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

Faculty of Medicine and Health Sciences

Badajoz, Badajoz, 06006, Spain

Location

Related 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.

  PMID: 33759439 BACKGROUND

• 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.

  PMID: 30717426 BACKGROUND

• 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.

  PMID: 1930310 BACKGROUND

• 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.

  PMID: 15377573 BACKGROUND

• 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.

  PMID: 23035006 BACKGROUND

• 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.

  PMID: 34615639 BACKGROUND

• 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.

  PMID: 21109520 BACKGROUND

• 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.

  PMID: 27784233 BACKGROUND

• 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.

  PMID: 6231933 BACKGROUND

• 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.

  PMID: 28983663 BACKGROUND

MeSH Terms

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Luis Espejo-Antúnez, Ph.D

  University of Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: February 15, 2024
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)