Introduction
Low back pain (LBP) refers to pain in the posterior trunk, between the lower edge of the ribs and the top of the gluteal region, which includes lumbar, lumbosacral, and sacroiliac pain. It may also radiate to the lower limbs [1, 2]. LBP is a prevalent health issue affecting approximately 577 million people worldwide [3]. It is one of the leading causes of disability [4], which is defined as difficulties in one or more aspects of life, including personal, physical, or social functioning, due to an underlying condition [5].
Due to its chronic nature, LBP can lead to job loss, high medical costs, and various physical and psychological problems, making it a significant public health concern [6]. Based on duration, LBP is categorized into three types as follows: acute (lasting less than six weeks), subacute (six to twelve weeks), and chronic (more than twelve weeks) [2]. LBP is further classified into two main categories, namely specific and non-specific. Specific LBP includes cases where an identifiable anatomical or pathological cause is present, such as arterial aneurysms, epidural abscesses, vertebral compression fractures, spondyloarthropathies, malignancies, cauda equina syndrome, radicular pain, radiculopathy, or spinal stenosis. If no such pathology is identified, the condition is classified as non-specific LBP [7]. LBP imposes a significant financial burden on healthcare systems. A study in 2013 estimated that the economic burden of LBP on the UK government was approximately £2.8 billion annually [8].
Systematic review articles published in 2017 and 2019 indicate that proprioception is reduced in patients with LBP, and this reduction is associated with increased pain [9, 10]. One common intervention for LBP management is the use of lumbar support belts. Research suggests that one mechanism by which these belts alleviate pain is by enhancing proprioception in the lumbar and pelvic regions [11, 12].
A well-established method for improving proprioception in orthoses, particularly foot orthotics, is the incorporation of silicone pads. These pads stimulate the sense of touch, thereby enhancing proprioception [13]. Previous studies have shown that wearing lumbar belts can reduce pain and improve functional ability in patients with LBP [14-20]. However, a review of existing literature revealed no studies investigating the use of a sacroiliac belt with a textured silicone pad in patients with chronic LBP.
Accordingly, the primary objective of this study was to design and fabricate a textured silicone pad and integrate it into a lumbar belt to assess its impact on pain and disability in patients with chronic non-specific LBP. If proven effective, this prefabricated orthosis could be incorporated into mass production, providing an accessible solution for LBP patients. Additionally, the findings could inform further research and modifications in orthotic design to enhance treatment outcomes for LBP patients.

Materials and Methods
This study was conducted in 2022 at the Imam Reza Educational and Therapeutic Clinic in Shiraz City, Iran. The participant was a 48-year-old female with chronic LBP persisting for approximately four years. She had previously attempted pharmacological treatments, physiotherapy, and a standard lumbar belt, all of which provided only temporary or partial relief. The inclusion criteria were as follows: age between 30 and 50 years, LBP duration of more than 12 weeks, and a minimum pain score of 3 on the numerical visual analog scale (VAS) at baseline. Meanwhile, the exclusion criteria included the following items: having a history of lumbar surgery or fracture; concurrent use of other treatment methods; and pregnancy or childbirth within the past six months. The patient had discontinued all previous treatments for at least six months before the study. The magnetic resonance imaging and laboratory tests confirmed the absence of specific pathological causes for her pain.
After confirming eligibility, the patient was informed about the study objectives, expected participation requirements, duration, potential benefits, and risks. She provided written informed consent before participating. Baseline pain and disability levels were assessed using the VAS and the oswestry disability index (ODI).
The VAS, introduced by Huskisson in 1974 [21], consists of a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Its validity and reliability for assessing chronic pain severity have been well established [22]. The validated Persian version of the ODI was used in this study [23]. This questionnaire consists of ten sections, each scored on a scale from 0 to 5, with a maximum possible score of 50. Higher scores indicate greater disability. In each section, the degree of functional disability when performing daily activities is rated from zero (no pain when performing the activity) to five (inability to perform the activity due to severe pain) [24].
The patient’s pelvic circumference was measured between the anterior superior iliac spine and the greater trochanter, and the size of the belt was defined on this basis. The orthosis was positioned above the pubic bone (Figure 1). The belt applied a force of 50 Newtons, measured using a tensile dynamometer, and the appropriate fastening location was marked accordingly. We asked the patient to fasten the belt in the same place and to inform us if there is a noticeable change in size or weight, and to return to readjust the device [25].



During the fitting session, the patient was instructed to wear the orthosis while walking, sitting, and standing for 10 min to identify any discomfort. Once the proper fit and comfort were confirmed, the device was provided to the patient. She was instructed to wear the belt for at least eight hours daily during routine activities for six weeks. A logbook with dated pages was provided for her to record daily usage hours. After 6 weeks of using the intervention, the patient returned to our center and completed the VAS and Oswestry questionnaire for the second time. At this stage, we asked the patient to express their satisfaction with the treatment.

Design and fabrication of a belt with a textured silicone pad
Initially, a foam pad with a thickness of 2.5 cm was prepared in the shape of an isosceles triangle with a 15 cm base (approximately the distance between the two posterior superior iliac spines, which are common pain sites in patients with chronic LBP) and a height of 10 cm (estimated based on the lumbar region height of the patient). To allow the pad to fit more comfortably into the lumbar curvature, its thickness was gradually reduced from the central height toward the edges, ensuring that the two lateral edges of the triangle were 1.5 cm thick.
Next, a rectangular gypsum mold was created using calcium sulfate hemihydrate, a material commonly used in dental molds. The foam pad was placed inside the mold to form a hollow space. After the mold dried and the foam was removed, the placement points for the protrusions were determined. Specifically, a 1.5 cm margin was set on each side from the height of the triangle. A central 3 cm section remained unperforated to allow clearance for the spinous processes of the vertebrae. After defining these distances, equally spaced points at 2 cm intervals were marked on the mold. Holes were then drilled at these points using a drill bit with a 10 mm diameter. To ensure uniform hole depth, the first 10 mm of the drill bit was marked with ink (Figure 2).
Once the holes were prepared, triangular pads were fabricated using medical-grade silicone (room temperature vulcanizing type with low viscosity and Shore 10 hardness, code 3040, from the Shimi Afsoon company, which sets at room temperature within 30 to 40 min; Figure 3). After 24 h, once the silicone had fully cured, the pads were removed. Velcro adhesive was attached to the back of the pad using a specialized silicone adhesive to allow attachment to the belt.
Subsequently, a 28 cm high belt made of neoprene was designed and manufactured for the patient. This belt was connected to the textured silicone pad using Velcro fasteners.



Results
As hypothesized, the use of the textured silicone pad in the lumbar belt had a positive impact on both pain intensity and disability. At the beginning of the study, the patient reported a pain score of 6 on the numerical VAS. After six weeks of wearing the belt, the pain score decreased by 66%, reaching 2.
Similarly, the ODI score before using the belt was 25, which significantly decreased by 56% to 11 after six weeks of use. The patient expressed high satisfaction with the intervention, highlighting the belt’s supportive sensation, superior effectiveness compared to standard lumbar belts, pain relief, and improved ease of daily activities (Table 1).



Additionally, as the study progressed, the patient gradually increased her belt usage due to its perceived benefits. However, she noted some drawbacks, including excessive warmth, odor buildup from prolonged use, and a sensation of pressure. Despite the latter, she found the pressure somewhat reassuring, as it provided a feeling of spinal support.

Discussion
This study introduced a novel lumbar belt with a textured silicone pad and evaluated its impact on pain and disability in a patient with chronic non-specific LBP. The results showed significant improvement in both pain intensity and functional disability over a short six-week period.
Proprioceptive receptors, located within muscles and joints, provide essential sensory feedback regarding body position and movement. Any biomechanical impairment may disrupt these signals, leading to poor posture control and increased mechanical stress on spinal structures, ultimately resulting in LBP. Previous studies confirm that proprioception is reduced in patients with LBP, and this impairment is closely associated with increased pain levels [8, 10, 26].
Deficient proprioception in LBP patients can also explain various observed deficiencies, such as delayed muscle reflexes to sudden trunk loading [27], impaired postural control [28], reduced balance [29], and altered movement patterns [30]. Since long-term motor deficits contribute to further injury, lumbar belts may mitigate LBP by enhancing proprioceptive feedback, thereby improving posture and motor coordination.
One common approach in orthopedic devices, particularly foot orthotics, involves the use of textured silicone pads to enhance proprioception. In this study, we incorporated such a pad into a lumbar belt and observed notable improvements in pain and disability within six weeks. These findings align with previous research on knee and ankle joints, demonstrating improved proprioception following the use of elastic bandages [31]. Given these promising results, further studies with larger sample sizes and extended follow-up periods are warranted.

Conclusion
The use of a lumbar belt with a textured silicone pad effectively reduced pain and disability in a patient with chronic LBP. Encouraged by the noticeable improvements, the patient voluntarily increased her daily belt usage, reaching up to 11 h per day. Additionally, she expressed a desire to continue using the belt beyond the study period, indicating its significant positive impact on her daily life.
Given the potential for mass production in various sizes, further research comparing this belt with conventional lumbar belts and other treatment methods is recommended. Larger clinical trials and longer observation periods could provide more definitive insights into its effectiveness. Moreover, since non-specific LBP is a recurrent condition, future studies should examine long-term pain recurrence following belt use to better understand its therapeutic mechanisms. Comparative studies with standard lumbar belts would also be beneficial in validating the effectiveness of textured silicone pads in LBP management.

Ethical Considerations

Compliance with ethical guidelines
All ethical principles were strictly followed in this study. The patient was fully informed about the study objectives, treatment procedures, and participation requirements. She retained the right to withdraw from the study at any time. Her identity was kept confidential, and written informed consent was obtained before participation.

Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Authors' contributions
Conceptualization: Bahareh Delshad, Mokhtar Arazpour, Seyed Reza Mousavi, Mohammad Ali Mardani; Methodology: Bahareh Delshad, Mokhtar Arazpour, Akbar Biglarian, Mohammad Ali Mardani; Data validation, Data analysis, Study investigation, Resources, Writing the original draft, Review and editing,and Visualization: All authors; Supervision: Mokhtar Arazpour, Seyed Reza Mousavi, Mohammad Ali Mardani; Project Administration: Mohammad Ali Mardani; Funding acquisition: Bahareh Delshad, Mohammad Ali Mardani.

Conflict of interest
The authors declare no conflict of interest.

Acknowledgments
The authors would like to express their sincere gratitude to Dr. Mohsen Benam, Neurosurgeon; Dr. Alireza Ashraf, Specialist in Physical Medicine and Rehabilitation; Dr. Hadi Forouzan, Specialist in Physical Medicine and Rehabilitation; Dr. Navid Noonzhad, Orthopedic Surgeon; and Dr. Hamidreza Farpoor, Specialist in Physical Medicine and Rehabilitation, for their valuable support, guidance, and professional insights which significantly contributed to the development of this work



 

1. Karukunchit U, Puntumetakul R, Swangnetr M, Boucaut R. Prevalence and risk factor analysis of lower extremity abnormal alignment characteristics among rice farmers. Patient Preference and Adherence. 2015; 9:785. [DOI:10.2147/PPA.S81898] [PMID] 
2. Van Tulder M, Becker A, Bekkering T, Breen A, del Real MTG, Hutchinson A, et al. European guidelines for the management of acute nonspecific low back pain in primary care. European Spine Journal. 2006; 15(Suppl 2):s169. [DOI:10.1007/s00586-006-1071-2] [PMID] 
3. Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, et al. Global low back pain prevalence and years lived with disability from 1990 to 2017: Estimates from the global burden of disease study 2017. Annals of Translational Medicine. 2020; 8(6):299. [DOI:10.21037/atm.2020.02.175] [PMID] 
4. Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al. A systematic review of the global prevalence of low back pain. Arthritis & Rheumatism. 2012; 64(6):2028-37. [DOI:10.1002/art.34347] [PMID]
5. Leonardi M, Bickenbach J, Ustun TB, Kostanjsek N, Chatterji S. The definition of disability: what is in a name? The Lancet. 2006; 368(9543):1219-21. [DOI:10.1016/S0140-6736(06)69498-1] [PMID]
6. Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. Plos One. 2020; 15(9):e0238544. [DOI:10.1371/journal.pone.0238544] [PMID] 
7. Hancock MJ, Maher CG, Latimer J, Spindler M, McAuley JH, Laslett M, et al. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. European Spine Journal. 2007; 16(10):1539-50. [DOI:10.1007/s00586-007-0391-1] [PMID] 
8. Hong J, Reed C, Novick D, Happich M. Costs associated with treatment of chronic low back pain: An analysis of the UK general practice research database. Spine. 2013; 38(1):75-82. [DOI:10.1097/BRS.0b013e318276450f] [PMID]
9. Cholewicki J, Shah KR, McGill KC. The effects of a 3-week use of lumbosacral orthoses on proprioception in the lumbar spine. Journal of Orthopaedic & Sports Physical Therapy. 2006; 36(4):225-31. [DOI:10.2519/jospt.2006.36.4.225] [PMID]
10. Ghamkhar L, Kahlaee AH. Pain and pain-related disability associated with proprioceptive impairment in chronic low back pain patients: A systematic review. Journal of Manipulative and Physiological Therapeutics. 2019; 42(3):210-7. [DOI:10.1016/j.jmpt.2018.10.004] [PMID]
11. Heydari Z, Aminian G, Biglarian A, Shokrpour M, Mardani MA. [Comparing the effects of lumbar-pelvic and pelvic belts on the activity of pelvic muscles in pregnant women with back and pelvic pain (Persian)]. Archives of Rehabilitation. 2023; 24(1):132-49. [DOI:10.32598/RJ.24.1.3542.1]
12. Azadinia F, Kingma I, Mazaheri M. Effect of external lumbar supports on joint position sense, postural control, and postural adjustment: A systematic review. Disability and Rehabilitation. 2023; 45(5):753-71. [DOI:10.1080/09638288.2022.2043464] [PMID]
13. Hatton AL, Dixon J, Rome K, Martin D. Standing on textured surfaces: Effects on standing balance in healthy older adults. Age and Ageing. 2011; 40(3):363-8. [DOI:10.1093/ageing/afr026] [PMID]
14. Ward JS. Influence of a sacroiliac belt on pain and functional impairment in patients with low back pain: A randomized trial. Journal of Chiropractic Medicine. 2022; 21(3):141-8. [DOI:10.1016/j.jcm.2022.06.001] [PMID] 
15. Ludvig D, Preuss R, Larivière C. The effect of extensible and non-extensible lumbar belts on trunk muscle activity and lumbar stiffness in subjects with and without low-back pain. Clinical Biomechanics. 2019; 67:45-51. [DOI:10.1016/j.clinbiomech.2019.04.019] [PMID]
16. Edgar K, Appel A, Clay N, Engelsgjerd A, Hill L, Leeseberg E, et al. Influence of sacroiliac bracing on muscle activation strategies during 2 functional tasks in standing-tolerant and standing-intolerant individuals. Journal of Applied Biomechanics. 2019; 35(2):107-15. [DOI:10.1123/jab.2018-0197] [PMID]
17. Chui KC, Jorge M, Yen S-C, Lusardi MM. Orthotics and prosthetics in rehabilitation E-Book. Amsterdam: Elsevier Health Sciences; 2019. [Link]
18. Anders C, Hübner A. Influence of elastic lumbar support belts on trunk muscle function in patients with non-specific acute lumbar back pain. Plos One. 2019; 14(1):e0211042. [DOI:10.1371/journal.pone.0211042] [PMID] 
19. Schott C, Zirke S, Schmelzle JM, Kaiser C, Fernández LAI. Effectiveness of lumbar orthoses in low back pain: Review of the literature and our results. Orthopedic Reviews. 2018; 10(4):7791. [DOI:10.4081/or.2018.7791] [PMID] 
20. Cholewicki J, Reeves NP, Everding VQ, Morrisette DC. Lumbosacral orthoses reduce trunk muscle activity in a postural control task. Journal of Biomechanics. 2007; 40(8):1731-6. [DOI:10.1016/j.jbiomech.2006.08.005] [PMID]
21. Huskisson EC. Measurement of pain. The Lancet. 1974; 304(7889):1127-31. [DOI:10.1016/S0140-6736(74)90884-8] [PMID]
22. McCormack HM, David JdL, Sheather S. Clinical applications of visual analogue scales: A critical review. Psychological Medicine. 1988; 18(4):1007-19. [DOI:10.1017/S0033291700009934] [PMID]
23. Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B. The oswestry disability index, the roland-morris disability questionnaire, and the quebec back pain disability scale: Translation and validation studies of the Iranian versions. Spine. 2006; 31(14):E454-9. [DOI:10.1097/01.brs.0000222141.61424.f7] [PMID]
24. Ahangar A, Hosseini SR. [Therapeutic effect of amitriptyline in management of chronic low back pain (Persian)]. Journal of Babol University of Medical Sciences. 2008; 10(2):44-9. [Link]
25. Damen L, Spoor CW, Snijders CJ, Stam HJ. Does a pelvic belt influence sacroiliac joint laxity? Clinical Biomechanics. 2002; 17(7):495-8. [DOI:10.1016/S0268-0033(02)00045-1] [PMID]
26. Tong MH, Mousavi SJ, Kiers H, Ferreira P, Refshauge K, van Dieën J. Is there a relationship between lumbar proprioception and low back pain? A systematic review with meta-analysis. Archives of Physical Medicine and Rehabilitation. 2017; 98(1):120-36. e2. [DOI:10.1016/j.apmr.2016.05.016] [PMID]
27. Radebold A, Cholewicki J, Panjabi MM, Patel TC. Muscle response pattern to sudden trunk loading in healthy individuals and in patients with chronic low back pain. Spine. 2000; 25(8):947-54. [DOI:10.1097/00007632-200004150-00009] [PMID]
28. D’hooge R, Hodges P, Tsao H, Hall L, MacDonald D, Danneels L. Altered trunk muscle coordination during rapid trunk flexion in people in remission of recurrent low back pain. Journal of Electromyography and Kinesiology. 2013; 23(1):173-81. [DOI:10.1016/j.jelekin.2012.09.003] [PMID]
29. Berenshteyn Y, Gibson K, Hackett GC, Trem AB, Wilhelm M. Is standing balance altered in individuals with chronic low back pain? A systematic review. Disability and Rehabilitation. 2019; 41(13):1514-23. [DOI:10.1080/09638288.2018.1433240] [PMID]
30. Alshehri M. Relationship between trunk postural control and low back pain [doctoral thesis]. Brisbane: The University of Queensland; 2024. [Link]
31. Collins AT, Blackburn JT, Olcott CW, Dirschl DR, Weinhold PS. The effects of stochastic resonance electrical stimulation and neoprene sleeve on knee proprioception. Journal of Orthopaedic Surgery and Research. 2009; 4:1-9. [DOI:10.1186/1749-799X-4-3] [PMID]