Radiculopathy LumbarNCT07305792
High Tone Power Therapy on Lumbosacral Radiculopathy Patients
A study testing High tone power therapy and selected physical therapy program in people with Radiculopathy Lumbar, run by October 6 University at 1 site in Egypt.
Trial summary
to investigate the effect of High Tone Power Therapy on Pain, Range of Motion and Quality of Life in Lumbosacral Radiculopathy Patients Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Radiculopathy Lumbar
- What is being tested?
- High tone power therapy and selected physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Radiculopathy Lumbar
- Being tested
- High tone power therapy, selected physical therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tone power therapyDevice
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 programOther
selected physical therapy program including (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve
| Study group | Role | What they receive |
|---|---|---|
| study group High tone power therapy | Experimental | Study group : received the selected physical therapy program in addition to High tone power therapy. Receives: Device: High tone power therapy; Other: 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 Receives: Other: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: four weeks
Secondary outcomes (1)
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
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start15 Dec 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
- Investigators
- Lama Saad ED Mahmoud, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305792
- Sponsor's protocol ID
- P.T.REC/012/005939
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Tone Power Therapy on Pain, Range of Motion and Quality of Life in Lumbosacral Radiculopathy Patients
- ClinicalTrials.gov ID
- NCT07305792
- Acronym / sponsor ID
- P.T.REC/012/005939
- Conditions
- Radiculopathy Lumbar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group High tone power therapy | Experimental | Device: High tone power therapy, Other: selected physical therapy programStudy group : received the selected physical therapy program in addition to High tone power therapy. |
| control group traditional therapy | Experimental | Other: selected physical therapy programreceived receive a selected physical therapy program only (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High tone power therapyHigh 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 | Device | study group High tone power therapy |
| selected physical therapy programselected physical therapy program including (Therapeutic Ultrasound device, Hot packs and Neurodynamic mobilization for sciatic nerve | Other | control group traditional therapy, study group High tone power therapy |
Primary outcome
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
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
1 secondary outcome
Visual analogue scale for pain (VAS-P)
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lama Saad ED Mahmoud principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High tone power therapy and selected physical therapy program in people with Radiculopathy Lumbar, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Pressure Threshold Algometer (time frame: four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.