NCT07305792

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

December 12, 2025

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Visual analogue scale for pain (VAS-P)

    four weeks

Study Arms (2)

study group High tone power therapy

EXPERIMENTAL

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

Device: High tone power therapyOther: selected physical therapy program

control group traditional therapy

EXPERIMENTAL

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

Other: selected physical therapy program

Interventions

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

control group traditional therapystudy group 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

study group High tone power therapy

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

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

Location

Study Officials

  • Lama Saad ED Mahmoud

    October 6 University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

December 15, 2025

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations