Effects of Device-Based and Manual Sensory Acuity Training on Chronic Low Back Pain: A Three-Arm Randomized Controlled Trial Protocol

Medipol University0 个研究点目标入组 66 人开始时间: 2026年8月15日最近更新: 2026年5月13日

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 66
主要终点: Visual Analog Scale (VAS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Chronic low back pain (CLBP) is a leading cause of disability worldwide and affects a large proportion of working-age individuals. Cortical reorganization in CLBP, particularly within the sensorimotor cortex, has been shown to negatively influence sensory acuity and motor control. The neuroplasticity underlying this reorganization may enhance the effectiveness of sensorimotor retraining therapies that involve specific stimulus features targeting somatosensory cortical regions.

This randomized controlled trial will include three groups: a device-assisted sensory acuity training group, a manual sensory acuity training group, and a control group receiving conventional physiotherapy. In this study, device-assisted sensory acuity training will be delivered using a standardized vibrotactile interface that presents controlled stimuli and records participant responses. The intervention will be structured to target sensory acuity components similar to those addressed in manual training.

Accordingly, the structured training protocol will include:

localization training to improve detection of stimulus location,
orientation discrimination to identify stimulus direction,
temporal acuity training to distinguish timing differences between tactile stimuli and
graphesthesia training to improve recognition of shapes or letters drawn on the skin through tactile input.

The primary aim of this study is to evaluate sensory acuity in individuals with CLBP and to determine the effects of a structured manual and technology-based sensory acuity training program, combined with conventional physiotherapy, on pain intensity (VAS), lumbar two-point discrimination, and a composite sensory acuity score.

We hypothesize that adding manual and technology-based structured sensory acuity training (SAT) program to a conventional physiotherapy regimen including motor control exercises will support central nervous system reorganization, improve sensory profiles, and lead to improvements in pain-related variables, disability, and quality of life.

Through this structured SAT program, we aim to provide an approach that evaluates and trains multiple dimensions of sensory acuity in CLBP, including localization, orientation, and temporal discrimination.

详细描述

This study consists of three research groups: the Technology-Based Sensory Acuity Training Group (T-SATG), the Manual Sensory Acuity Training Group (M-SATG), and the Control Group (CG). All groups will receive conventional physiotherapy for comparison purposes. In addition, a structured technological SAT program will be administered to the T-SATG, and a structured manual SAT program will be administered to the M-SATG, while the control group will receive a patient education (PE) program designed not to provide additional sensory stimulation. This approach will ensure equal session duration across all groups.

All individuals with non-specific chronic low back pain (NCLBP) will receive conventional physiotherapy for 30 minutes per day, three days a week, for four weeks. All patient admissions will be conducted under the guidance of the same physiotherapy team to ensure consistent implementation of the protocol and to maintain patient safety throughout the study. Participants will be asked to refrain from receiving any additional treatments for their lower back during the four-week intervention period, and any changes in medication type or dosage will be recorded.

In this study, the motor control exercise (MCE) program administered as part of conventional physiotherapy will aim to optimize control of the spine and pelvis through appropriate muscle activation, postural alignment, and movement integrity. The program is based on a graded progression system that emphasizes activation of the transversus abdominis and multifidus muscles. It will begin with fundamental exercises involving isolated contractions of these muscles, followed by more complex movements-such as bridging and quadruped exercises-that require coordinated activation of both muscles. During each session, the physiotherapist will guide participants to ensure correct exercise technique and provide necessary adjustments.

Individuals with non-specific chronic low back pain (CLBP) included in the T-SATG and M-SATG will receive sensory acuity training (SAT) for 30 minutes, three times per week, over a four-week period, with the difficulty level progressively increasing each week. This training program comprises four sensory acuity components delivered sequentially: Localization Acuity Training (LAT), Orientation Acuity Training (OAT), Temporal Acuity Training (TAT), and Graphesthesia Training (GT).

The sensory acuity training program will follow a structured weekly progression. During Weeks 1 and 2, participants will complete three core components of the training: Localization Acuity Training (LAT), Orientation Acuity Training (OAT), and Temporal Acuity Training (TAT). In Weeks 3 and 4, the same three components will continue, and Graphesthesia Training (GT) will be added to the protocol, expanding the program to four sensory acuity domains. This stepwise progression is designed to gradually increase training complexity and ensure the systematic development of sensory discrimination abilities across the four-week intervention period.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 25 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age between 25-45 years
•No spinal fracture or acute disc herniation
•Pain duration ≥ 3 months
•Pain intensity ≥ 4/10
•Central Sensitization Scale (CSI) score ≥ 40
•No current psychiatric illness or cognitive impairment
•No contraindications to exercise

排除标准

•Serious spinal pathologies (lumbar stenosis, spondylolisthesis, tumor, infection, metastasis, osteoporotic fracture, severe structural deformities, inflammatory arthritis)
•Conditions with radicular involvement or neurological deficits (sciatica, nerve root compression)
•Systemic or neurological diseases (diabetes mellitus, neuromuscular diseases, serious central or peripheral nervous system diseases, epilepsy)
•Mental disorders
•Pregnancy
•Lower extremity injuries
•Spinal surgery within the last three years
•Chronic generalized pain syndromes (fibromyalgia, chronic fatigue syndrome)
•Individuals receiving other treatment for non-specific chronic low back pain during the study period.

研究组 & 干预措施

Technology-Based Sensory Acuity Training Group (T-SATG)

Experimental

Participants in this arm will receive technology-based sensory acuity training delivered through the TactiPain device in addition to motor control exercises. The training will include vibrotactile localization, orientation, temporal acuity, and graphesthesia tasks administered with a progressive weekly protocol. Vibrotactile stimuli will be presented through a 4×4 matrix of 16 vibration motors positioned over the lumbar region, with weekly progression in intensity, vibration duration, and inter-stimulus intervals. Randomized sequences will be used for all tasks, and progression will occur when ≥80% accuracy is achieved. A response interval of 10 seconds will be provided between stimuli, with 1 minute rest periods between training sets and 2 minute rest periods between different training parameters.

干预措施: Technology-Based Sensory Acuity Training Group (T-SATG) (Device)

Manual Sensory Acuity Training Group (M-SATG)

Experimental

In addition to motor control exercises, individuals with NLBP included in the M-SATG will receive sensory acuity training with progressively increasing levels of difficulty. This training will include manually administered components of localization acuity, orientation acuity, temporal acuity, and graphesthesia. All sensory acuity components (localization, orientation, temporal acuity, graphesthesia) will be delivered in randomized sequences generated prior to each session. During localization, orientation, and temporal acuity tasks, a standardized adhesive grid template consisting of 16 points will be applied to the lumbar region to guide stimulus delivery. Throughout the training process, participants will progress to the next training stage once they achieve 80% accuracy for that week. A response interval of 10 seconds will be provided between stimuli, with 1 minute rest periods between training sets and 2 minute rest periods between different training parameters.

干预措施: Manual Sensory Acuity Training Group (M-SATG) (Other)

Control Group (CG)

Experimental

All individuals in this group will receive Motor Control Exercises (MCEs) for 30 minutes to promote correct muscle activation, postural alignment, movement integrity, and optimal control of the spine and pelvis. In addition to MCEs, participants will also receive a structured 30-minute patient education (PE) program, matched to the duration of the structured SAT program administered in the other groups. The PE program will focus on developing safe movement strategies, postural awareness, ergonomics, and self-management skills.

干预措施: Control Group (CG) (Other)