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NCT Number: NCT07619794

tSCS and AR on Pain and Balance in Diabetic Peripheral Neuropathy

tSCS and AR-based training have individually shown benefits in neuromotor rehabilitation; no study to date has evaluated their combined effects on pain, balance, lower-limb strength, retention, and vibration sense in diabetic neuropathy. The rationale for combining them lies in their complementary mechanisms: tSCS at 30 Hz activates large-diameter Aβ afferents, inhibiting nociceptive input, enhancing spinal excitability, and facilitating motor activation.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

About this study

In Pakistan, 26.3% of the population is affected, and DN impacts about 40% of cases, with early signs reducing function. (9-11) Standard care includes glycemic control, medications like duloxetine and pregabalin, topical agents, and modalities such as TENS.

Alongside pain, lower-limb strength declines due to motor axonal degeneration and prolonged disuse, (1) limiting mobility and increasing the risk of falls. Balance impairments are frequent in DN and result from compromised proprioceptive input and impaired postural control mechanisms; (4) these deficits are exacerbated by pain-related inactivity and muscular weakness.

Augmented reality (AR) based rehabilitation delivers multisensory feedback, such as visual, vestibular, and proprioceptive inputs, during interactive, task-specific training. It enhances sensorimotor coordination, dynamic postural stability, and proprioceptive reweighting. AR training can improve balance responses, promote lower-limb engagement, and reinforce accurate proprioceptive input.

The tSCS enabled stepping in individuals with complete motor loss, confirming its impact on lower-limb functional recovery. Additionally, this stimulation frequency targets mechano-sensory pathways associated with vibration sense and is believed to support retention of sensorimotor gains through repeated activation of neuroplastic mechanisms at the spinal and cortical levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than or equals to 4 score on Douleur Neuropathique 4 Questionnaire
  • More than or equals to 6 Hz at Neurothesiometer
  • More than or equals to 4 score on the Numeric Pain Rating Scale (NPRS)

Exclusion criteria

  • Cognitively compromised (MOCA ≤ 26/30)
  • Metallic implants at skull
  • Shunting
  • Skin allergy

Treatment and study plan

transcutaneous spinal cord stimulation

Other

Transcutaneous spinal cord stimulation will be administered non-invasively using surface electrodes placed over the D12-L1 spinal segment. This segmental level has been shown to effectively engage lower-limb motor and sensory networks across multiple spinal segments. Stimulation will be delivered using the Soterix 1×1 Transcutaneous Electrical Stimulation (TES) unit. Stimulation will be applied at a frequency range of 30 Hz. Pulse duration of 1 ms, and intensity will be set at 2 mA. A ramp-up and ramp-down time of 30 seconds will be used to enhance participant comfort during the start and end of each stimulation session, following standardized electrode placement and safety protocols.

Augmented Reality

Other

AR-based rehabilitation will consist of interactive balance and coordination tasks conducted in a virtual environment, with real-time visual feedback provided to guide movement accuracy and postural control. The core training block will include five structured modules: interactive kicking exercises to promote ankle and knee coordination; color-target foot-reaching tasks to enhance proprioception and reaction time; virtual obstacle navigation to improve gait and stepping control; static and dynamic balance challenges, such as maintaining posture on virtual planks; and lower-limb strengthening activities, including squats and stepping-based games. Each module will be performed for 5-8 minutes, with brief rest periods between tasks.

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Up to week 5 (baseline/week 1/week 5)

    The Numeric Pain Rating Scale (NPRS) is a quick, 11-point measure (0 = no pain to 10 = worst imaginable) commonly used across clinical and research settings. Recent studies demonstrate test-retest reliability ranging from 0.58 to 0.93 (good to excellent), with moderate evidence for a minimal clinically important difference (MCID) of 1.5-2.5 points.

  2. Time Up and Go (TUG)

    Time frame: Up to week 5 (Baseline/week 1/week 5)

    The TUG test is a simple, clinically validated tool used to assess dynamic balance and functional mobility. It requires an individual to rise from a seated position, walk three meters, turn, return, and sit down. The TUG demonstrated excellent test-retest reliability, with intraclass correlation coefficients (ICC) ranging from 0.89 to 0.94 across multiple trials.

Secondary outcomes

  1. 30 Second Chair Stand Test

    Time frame: Up to week 5 (Baseline/week 1/week 5)

    The 30-Second Chair Stand Test is a widely used, performance-based tool for assessing lower-limb strength and functional mobility. Among individuals with type 2 diabetes mellitus, a population commonly affected by diabetic neuropathy, the test has demonstrated excellent reliability. A test-retest intraclass correlation coefficient (ICC) of 0.92, indicating excellent relative reliability. In terms of measurement precision, the standard error of measurement (SEM) was 1.08 repetitions, and the smallest real difference (SRD) was 3 repetitions, reflecting the threshold for clinically meaningful change.

  2. Neurothesiometer

    Time frame: Up to week 5 (Baseline/Week 1/week 5)

    The neurothesiometer is a non-invasive and reliable instrument used to assess vibration perception threshold (VPT). It has demonstrated excellent reliability, with intra-class correlation coefficients (ICCs) exceeding 0.90, indicating strong measurement consistency. A VPT cut-off value of ≥ 6 Hz is indicative of neuropathy. Owing to its ease of use, objective quantification, and ability to detect subclinical neuropathy, the neurothesiometer is highly valuable in clinical practice. Its superior standardization makes it a preferred method for evaluating protective sensation and vibration loss, particularly in individuals with diabetes.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahnoor Imtiaz, DPT

CONTACT

[email protected]

0092 315 5214237

Mirza Obaid Baig, MSPT

CONTACT

[email protected]

00923332238706

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Transcutaneous Spinal Cord Stimulation (tSCS) and Augmented Reality (AR) Training on Pain and Balance in Diabetic Neuropathy Patients.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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