Device-Based vs Manual Sensory Training in Low Back Pain

ConditionLow Back Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age25-45

SponsorMedipol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 25-45 years

No spinal fracture or acute disc herniation

Pain duration ≥ 3 months

Pain intensity ≥ 4/10

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Technology-Based Sensory Acuity Training Group (T-SATG)
Device
The vibrotactile stimuli will be delivered according to a predefined weekly progression. In Week 1, high-intensity vibrations will be applied with a duration of 500 ms and an inter-stimulus interval of 1 second. In Week 2, medium-intensity vibrations will be delivered with a duration of 500 ms and a 500-ms inter-stimulus interval. In Week 3, medium-intensity vibrations will be delivered with a duration of 200 ms and a 200-ms inter-stimulus interval, and in Week 4, low-intensity vibrations will be applied with a duration of 100 ms and a 100-ms inter-stimulus interval. This structured progression is designed to ensure a gradual increase in task difficulty and to standardize the vibrotactile training across participants.
Control Group (CG)
Other intervention
The MCE program will follow a progressive approach targeting activation of the transversus abdominis and multifidus muscles. It will begin with basic exercises emphasizing isolated contractions and progress to more complex movements involving co-activation of both muscles, including bridging and quadruped exercises. As part of the PE component, participants will receive fundamental information regarding spinal health, neutral spine posture, and appropriate movement strategies for daily activities. Guidance will be provided on ergonomics, including lifting techniques, workspace organization, and methods to reduce mechanical load on the lower back. The program will also support self-care by promoting regular physical activity, appropriate pacing during flare-ups, adequate rest, and healthy lifestyle habits.
Manual Sensory Acuity Training Group (M-SATG)
Other intervention
To progressively increase difficulty, Semmes-Weinstein monofilaments with thick and thin tips will be used to vary stimulus pressure. Stimulus duration will advance weekly: week 1 - thick tip 5 s, week 2 - thick tip 2 s, week 3 - thin tip 5 s, week 4 - thin tip 2 s, with a stopwatch ensuring standardization and fixed intervals between stimuli. All sensory acuity tasks (localization, orientation, temporal acuity, and graphesthesia) will be delivered using randomized sets generated by random.org to prevent habituation. Responses will be recorded weekly to track progress. An adhesive 16-hole grid template will be placed between the last rib and sacrum on each participant before each session.

Treatment groups

66 Participants

are divided into 3 treatment groups

Group A: Manual Sensory Acuity Training Group (M-SATG)Experimental treatment 1 intervention

Group B: Control Group (CG)Experimental treatment 1 intervention

Group C: Technology-Based Sensory Acuity Training Group (T-SATG)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Visual Analog Scale (VAS)

In order to evaluate the pain levels of the participants, the average pain intensity in the last 7 days will be evaluated with the Visual Analog Scale (VAS).

Time frame