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High Tone Power Therapy on Lumbosacral Radiculopathy Patients

NCT ID: NCT07305792

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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

Conditions

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Radiculopathy Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

Study group : received the selected physical therapy program in addition to High tone power therapy.

Group Type EXPERIMENTAL

High tone power therapy

Intervention Type 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

Intervention Type OTHER

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

control group

received receive a selected physical therapy program only (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve

Group Type EXPERIMENTAL

selected physical therapy program

Intervention Type OTHER

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

Interventions

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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

Intervention Type DEVICE

selected physical therapy program

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Lama Saad El-Din Mahmoud

Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lama Saad ED Mahmoud

Role: PRINCIPAL_INVESTIGATOR

October 6 University

Locations

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October 6 University

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Lama Saad El-Din Mahmoud

Role: CONTACT

Phone: 00201157592636

Email: [email protected]

Lama Saad El-Din ED Mahmoud

Role: CONTACT

Phone: 00201157592636

Email: [email protected]

Facility Contacts

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faculty of physical therapy October 6 University

Role: primary

Other Identifiers

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P.T.REC/012/005939

Identifier Type: -

Identifier Source: org_study_id