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Clinical Trials/NCT07305792
NCT07305792
Completed
Not Applicable

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

October 6 University1 site in 1 country52 target enrollmentStarted: December 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
1
Primary Endpoint
Short Form Health Survey (SF-36)

Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

study group High tone power therapy

Experimental

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

Intervention: High tone power therapy (Device)

study group High tone power therapy

Experimental

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

Intervention: selected physical therapy program (Other)

control group traditional therapy

Experimental

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

Intervention: selected physical therapy program (Other)

Outcomes

Primary Outcomes

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

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.

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

The RAND 36-Item Health Survey (Version 1.0) (SF-36) questionnaires,

Time Frame: four weeks

The RAND 36-Item Health Survey, also known as 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.

Secondary Outcomes

  • Visual analogue scale for pain (VAS-P)(four weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lama Saad El-Din Mahmoud

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

October 6 University

Study Sites (1)

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