NCT07393750

Brief Summary

To compare between high-power laser versus pulsed electromagnetic therapy on pain and Hoffman reflex in lumbar radiculopathy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress14%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

January 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 24, 2026

Last Update Submit

January 31, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Visual Analogue Scale (VAS)

    The Visual Analogue Scale (VAS) is a tool for measuring pain intensity, using a continuous 10-centimeter line with "no pain" at one end (0) and "worst imaginable pain" at the other (10), where patients mark their current pain level, with a ruler used to measure the score from the zero mark for a score out of 10, commonly used in research and clinical settings to track pain changes.

    baseline

  • Hoffman reflex or H reflex

    H-reflex will be measured in the soleus muscle by stimulating the tibial nerve with a one-millisecond pulse at 0.2pps of H-max. The peak-to-peak amplitude of the highest recorded H-reflex and the latencies of four spaced traces for both lower extremities will be averaged for each participant. The soleus H-reflex will be evoked by tibial nerve stimulation in the popliteal fossa.

    baseline

Study Arms (3)

study group 1 (G1a)

EXPERIMENTAL

study group (G1a) will receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group.

Device: high-power laserOther: physiotherapy program

study group 2 (G1b)

EXPERIMENTAL

The study group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group.

Device: Pulsed electromagnetic fieldOther: physiotherapy program

control group (G2)

EXPERIMENTAL

The control group patients will receive selected physiotherapy program.

Other: physiotherapy program

Interventions

The study group (G1a) receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group.

study group 1 (G1a)

group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group.

study group 2 (G1b)

Selected Physical therapy program in the form of: 1. Nerve gliding exercise for sciatic nerve. 2. Hot pack for 15 minutes, for 12 sessions. 3. Core stability exercise (static abdominal exercise, bridging, knee to chest).

control group (G2)study group 1 (G1a)study group 2 (G1b)

Eligibility Criteria

Age55 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sixty lumbar radiculopathy patients, of both sexes, will represent the sample.
  • The patient's age will range from 55 to 68 years old.
  • Patients with degenerative lumbar disc lesion at L5-S1 confirmed by MRI and latency in H- reflex.
  • Patients with unilateral sciatic radiating pain (from 5 to 8 by visual analogue scale).
  • Patient with normal cognitive function (MME more than 25)
  • BMI from 20-29.9

You may not qualify if:

  • The patients will be excluded if they have one of the followings:
  • Patients with pacemakers and presence of electronic implants.
  • Pregnant women.
  • History of or existing malignant conditions, active tuberculosis of the lungs.
  • Any medical condition that may cause sciatic nerve lesion except lumbar radiculopathy, (e.g., diabetes mellitus or collagen disorders).
  • Cardiac, renal or hepatic failures recent or previous history of seizures or epilepsy.
  • Previous surgery at L5-S1.
  • Bleeding disorders.
  • Serious infections of a viral, bacterial and fungal origin, conditions after organ transplants, upper motor neuron lesions.
  • Patients with cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptair Hospital

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

RadiculopathyReflex, Abnormal

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • PROF. DR. MOSHERA HASSAN DARWISH, Professor of Physical Therapy

    Cairo University

    STUDY CHAIR

Central Study Contacts

Menna Tallah Sherif Hassan, B.SC. in Physical Therapy

CONTACT

Dr.Marwa Mostafa Abdel Moneim, Lecturer of Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Study The selected patients will be randomly assigned into "three" equal groups: study group 1 (G1a), study group 2 (G1b) and control group (G2). The control group patients will receive selected physiotherapy program. The study group (G1a) will receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group. The study group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist Egyptair Hospital

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 6, 2026

Study Start

March 29, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-01

Locations