High Tone Power Therapy on Lumbosacral Radiculopathy Patients

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

Study Overview

• Status: Completed
• Conditions: Radiculopathy Lumbar
• Intervention / Treatment: Device: High tone power therapy; Other: selected physical therapy program

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Sheikh Zayed City Giza 1133 Egypt
    • Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt
      • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group High tone power therapy; Study group : received the selected physical therapy program in addition to High tone power therapy.	Device: High tone power therapy; 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; Other: selected physical therapy program; selected physical therapy program including (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve
Experimental: control group traditional therapy; received receive a selected physical therapy program only (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve	Other: selected physical therapy program; selected physical therapy program including (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Pressure Threshold Algometer	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.	four weeks
Back range of motion (BROM) goniometer device	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	four weeks
Short Form Health Survey (SF-36)	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	four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale for pain (VAS-P)	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	four weeks

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: Lama Saad ED Mahmoud, October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: P.T.REC/012/005939

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No