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Completed

NCT Number: NCT07305792

High Tone Power Therapy on Lumbosacral Radiculopathy Patients

to investigate the effect of High Tone Power Therapy on Pain, Range of Motion and Quality of Life in Lumbosacral Radiculopathy Patients

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Key information

Conditions

Radiculopathy Lumbar

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University

Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt

About this study

BACKGROUND: Lumbosacral radiculopathy is a disorder that causes pain in the lower back and hip, as radicular pain is commonly caused by the compression of lumbar spinal nerve roots. High-tone therapy represents a novel form of electrotherapy distinguished from traditional methods by its dynamic modulation of frequency and amplitude. This innovative approach delivers increased energy levels to tissues. Therefore, there has been significant interest in utilizing high-tone therapy for treating various disorders HYPOTHESES: It will be hypothesized that there will be no statically Effect of High Tone Power Therapy on Pain, Range of Motion and Quality of Life in Lumbosacral Radiculopathy Patients RESEARCH QUESTION: Is there an Effect of High Tone Power Therapy on Pain, Range of Motion and Quality of Life in Lumbosacral Radiculopathy Patients

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Their ages range from 35 to 50 years.
  • Both sex.
  • Back pain for more than six months; radiating unilaterally down to one lower limb over the dermatomal distributions of L4-L5, L5-S1 nerve roots.
  • Radiological confirmation of disc herniation or protrusion at L4-5 or L5-S1 levels by MRI.
  • Symptom duration of at least 4 weeks and not more than 6 months.
  • Positive Straight Leg Raise test
  • Body mass index (18.5 - 24.99Kg/m2).

Exclusion criteria

  • Red flags: spinal tumors, cauda equina syndrome, spinal fractures, osteoporosis, infection.
  • Bilateral symptoms.
  • Spondylolisthesis, spondylitis, spinal canal stenosis.
  • Previous lumbopelvic or hip surgery or injection.
  • Any hip structural abnormality such as malformations, impingements and degeneration.
  • Postural deviations such as scoliosis, kyphosis and lateral shift.
  • Fibromyalgia.
  • Pregnancy and Gynecological problems.
  • Systemic inflammatory conditions (e.g., rheumatoid arthritis and ankylosing spondylitis)
  • Uncontrolled chronic conditions (e.g., diabetes mellitus with neuropathy and severe cardiovascular disease)

Treatment and study plan

High Tone Power Therapy

Device

High Tone Power Therapy (HiToP), or High-Frequency External Muscle Stimulation (HTEMS), is an advanced form of electrotherapy that uses medium-frequency sinusoidal currents with simultaneously modulated amplitude and frequency to treat various conditions, especially neurological symptoms and pain

selected physical therapy program

Other

selected physical therapy program including (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve

Primary outcomes

  1. Pain Pressure Threshold Algometer

    Time frame: four weeks

    An algometer is a device used with pressure algometry to measure the pain pressure threshold (PPT), which is the point at which a steadily increasing, non-painful pressure stimulus is perceived as painful.

  2. Back range of motion (BROM) goniometer device

    Time frame: four weeks

    is a specialized instrument, often using inclinometers and magnets, that provides accurate and repeatable measurements of spinal movements such as flexion, extension, rotation, and lateral side bend

  3. Short Form Health Survey (SF-36)

    Time frame: four weeks

    The the SF-36, is a 36-item questionnaire developed by the RAND Corporation to measure health-related quality of life across eight domains: physical functioning, bodily pain, role limitations (due to physical or emotional problems), social functioning, emotional well-being, vitality (energy/fatigue), and general health. It also includes an additional item to assess self-perceived health changes over time. A score range from 0 to 100. high scores indicate more quality of life

Secondary outcomes

  1. Visual analogue scale for pain (VAS-P)

    Time frame: four weeks

    The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS has been widely used in diverse adult populations for example; those with rheumatic diseases, patients with chronic pain Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Effect of High Tone Power Therapy on Pain, Range of Motion and Quality of Life in Lumbosacral Radiculopathy Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Apr 8, 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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