Device-Based vs Manual Sensory Training in Low Back Pain

NCT07277803 | Not Yet Recruiting DMC

• 2 other identifiers: MedipolUniversity2025225S070
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Chronic pain; physiotherapy and rehabilitation; radial/local vibration; low back pain; pain treatment; tactile feedback; mobile applications; wearable technologies; embedded system design

Outcome Measures

Primary Outcomes (4)

• 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).

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

• Two-Point Discrimination Test (TPDT)

  TPDT skill levels of individuals with CLI will be measured using a commercially available mechanical aesthesiometer (Baseline, 12-1480 Aesthesiometer).

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

• Sensory Acuity Composite Score

  Localization, orientation, and temporal acuity accuracy (%) will be calculated by taking the average value of the sum of the levels. Evaluations will be made using the thick end of the monofilament. Each application will be performed in two sets of 20 repetitions in random order, each set including location, direction, and number of stimuli. Localization accuracy will be assessed using a locognosy test, which measures the percentage of correct responses by touching areas numbered 1 to 16 on a 4x4 grid, with participants pointing to the correct point on the figure.

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

• Roland Morris Disability Questionnaire (RMDQ)

  The Roland Morris Disability Questionnaire (RMDQ), consisting of 24 questions focusing on regular activities of daily living, will be used to assess participants' disability levels. The total score ranges from 0 to 24, with higher scores reflecting increasing disability and scores exceeding 14 indicating severe disability.

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

Secondary Outcomes (8)

• Pain Pressure Threshold (PPT)

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

• Left-Right Judgment Task (LRJT)

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

• Tampa Kinesiophobia Scale (TKS)

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

• Pain Catastrophizing Scale (PCS)

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

• Joint Position Sense (JPS)

  Baseline (prior to the intervention), end of treatment (after the 12th session), and 6 months post-treatment.

Study Arms (3)

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.

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

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.

Other: Control Group (CG)

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.

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

Interventions

Control Group (CG) OTHER

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.

Control Group (CG)

Manual Sensory Acuity Training Group (M-SATG) OTHER

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.

Manual Sensory Acuity Training Group (M-SATG)

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.

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

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• AYSE GURLUK, PhD (c)

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AYSE GURLUK, PhD (c)

CONTACT

+905387626212; aysegurluk@gmail.com

PINAR KAYA SARİBAS, ASSOCIATE PROFESSOR

CONTACT

+905415909667; pkaya@medipol.edu.tr

Study Design

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

Model Details: This is an interventional randomized controlled trial with parallel assignment. The study was designed as a single-blind study; only the clinical evaluator will be blinded. Participants and therapists administering the intervention will not be blinded due to the nature of the intervention. The evaluator's lack of knowledge about group assignments was planned to ensure objectivity of the measurements and minimize the risk of bias. Patients and the public were not involved in the design or conduct of this trial. The study design and intervention protocols were informed by existing scientific evidence and clinical guidelines. Participant burden was considered in determining session duration and assessment procedures. Participants will not be involved in the interpretation or dissemination of the study findings.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: December 11, 2025
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: May 13, 2026

Record last verified: 2025-12