NCT06296303

Brief Summary

Purposes of the study To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 6, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 29, 2024

Last Update Submit

February 29, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain

    Visual analogue scale

    Change from Baseline pain and function at 6 weeks

  • Disability

    Oswestry disability index

    Change from Baseline pain and function at 6 weeks

  • Sciatic nerve cross sectional area

    Diagnostic Ultrasound

    Change from Baseline pain and function at 6 weeks

Secondary Outcomes (2)

  • H-reflex amplitude

    Change from Baseline pain and function at 6 weeks

  • H-reflex side-to-side amplitude (H/H) ratio

    Change from Baseline pain and function at 6 weeks

Study Arms (3)

Pulsed electromagnetic therapy group

EXPERIMENTAL

Patients in this group will receive Pulsed electromagnetic therapy + Conventional physical therapy

Other: Pulsed electromagnetic therapyOther: Conventional physical therapy

Ultrasound phonophoresis group

EXPERIMENTAL

Patients in this group will receive Ultrasound phonophoresis + Conventional physical therapy

Other: Ultrasound phonophoresisOther: Conventional physical therapy

Control group

ACTIVE COMPARATOR

Patients in this group will receive Conventional physical therapy

Other: Conventional physical therapy

Interventions

Pulsed etromagnetic therapy (1000 gauss) on sciatic nerve in gluteal fold. ( 30 min )

Pulsed electromagnetic therapy group

Phonophoresis using dexamethasone and topical diclofenac sodium gel on sciatic nerve in subgluteal fold and mid thigh

Ultrasound phonophoresis group

Conventional physical therapy consisting of 1. IF current on lumbar spine. (15 min ) 2. Hotpack on lumbar spine . (15 min ) 3. Neurodynamic mobilization . 4. Mobilization and manipulation for lumbar spine. 5. Exercises

Control groupPulsed electromagnetic therapy groupUltrasound phonophoresis group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient age ranges from 20 -45
  • Unilateral chronic lumbosacral radiculopathy
  • Intervertebral disc herniation confirmed by MRI
  • one of the following :
  • H- reflex amplitude side to side difference 0.67 in absence of latency difference.
  • H- reflex amplitude side to side difference smaller than 0.5 in p of latency difference.
  • Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec.

You may not qualify if:

  • Systematic disease
  • Lumbar canal stenosis
  • Pervious surgeries
  • Scoliosis
  • Kyphosis
  • Spinal fracture
  • Bilateral symptoms
  • Steroid injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Mohamed Badr Hassanein, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

March 3, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

March 6, 2024

Record last verified: 2024-02