Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy

NCT06102304 | Recruiting

• 1 other identifier: P.T.REC/012/004747
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Upper limb nerve root dysfunction with increased active myofascial trigger point in upper trapezius is common problem in patients with cervical radiculopathy. The purpose of this study was to evaluate the effect of Extracorpeal shock wave on the myo-electric and nerve function responses in patients with cervical radiculopathy.

Conditions

Cervical Radiculopathy

Keywords

Cervical Radiculopathy; Nerve root Dysfunction; Trigger points; Focused Extracorpeal Shock Wave

Outcome Measures

Primary Outcomes (5)

• Amplitude of median nerve dermatomal somatosensory evoked potential

  After the stimulation was performed and the traces were superimposed to ensure reproducibility, negative near field potential were detected and positive peak was detected to measure the peak to peak amplitude. This amplitude was measured. The distance between positive and negative peak , it is measures in millivolts (mV)

  Baseline Assessment and Immediately Post Treatment.

• Distal Latency of median nerve dermatomal somatosensory evoked potential

  Distal latency is defined as the interval between the stimulation of a compound muscle or selective dermatome and the observed response. It is measured in meter per second (m/s)

  Baseline Assessment and Immediately Post Treatment.

• Pain Pressure Threshold on upper trapezius

  Pain pressure Threshold (PPT) device will be used to detect tenderness and pain on the active myofascial trigger points on upper trapezius muscle. The 1-cm² rubber tip was applied perpendicularly over the myofascial trigger points and the power is switched on; a required pressure will be exerted on the site of myofascial trigger points by pressing the transducers firmly downwards. Measurements were recorded in kilograms of pressure per square centimeter (kg/cm\^2).

  Baseline Assessment and Immediately Post Treatment.

• Hand grip Strength

  Jamar hydraulic hand dynamometer will be used, it is a quantitative and an objective measure of the isometric muscular strength of the hand grip. It is a portable dynamometer used as a valid and reliable tool to reflect the upper limb strength. This instrument is scored using force production in kilograms (0-90) or pounds (0-200). Maximum grip was the mean of three trials. For each patient the both sides were assessed before treatment to collect the normative value for each patient. Mean of Maximum grip was compared pre and post treatment for each patient

  Baseline Assessment and Immediately Post Treatment.

• Level of radiating pain

  Numeric rating Scale (NRS) for pain will be used to assess level of pain radiating through the upper limb. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity . Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.

  Baseline Assessment and Immediately Post Treatment.

Study Arms (2)

Sham Extracorpeal Shock Wave

PLACEBO COMPARATOR

Control group (GA) Patients in (GA) will be treated by a designed physiotherapy program consisted of Myo-fascial release, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Median nerve neural glide techniques, Graduated strengthening exercises for the upper limb in addition to sham shockwave on the upper trapezius.

Device: Sham Extracorpeal shock wave

Focused Extracorpeal Shock wave

EXPERIMENTAL

Patients in (GB) will be treated by Focused Extracorpeal shockwave on the trigger points of upper trapezius in addition to the same physiotherapy program as GA.

Device: Focused Extracorpeal Shock wave

Interventions

Focused Extracorpeal Shock wave DEVICE

Focused Extracorporeal shock wave for 700 impulses of 0.056 mJ/mm at a frequency of 10 Hz to the taut band and 300 impulses surrounding the taut band was applied as low energy 2 sessions per week for 4 weeks. (EME S.r.l. via Degli Abeti 88/161122 Pesaro \[serial number: EM12681015\], Italy) was used as a focused extracorporeal shock wave therapy apparatus.

Focused Extracorpeal Shock wave

Sham Extracorpeal shock wave DEVICE

(EME S.r.l. via Degli Abeti 88/161122 Pesaro \[serial number: EM12681015\], Italy) was used as a focused extracorporeal shock wave therapy apparatus. The device will be used in the demo mood with no radiation or impulses applied.

Sham Extracorpeal Shock Wave

Eligibility Criteria

• Age: 36 Years - 46 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients suffer from unilateral discogenic cervical radiculopathy of lower cervical spine(C5-C6 and/ or C6-C7) as confirmed with MRI.
• All patients suffer from pain and tenderness on active trigger points of the upper trapezius .
• Age ranging from 36 to 46 years old.
• Duration of symptoms more than 3 months to avoid acute stage of inflammation.
• Side to side amplitude differences of 50% or more in DSSEPs measurement (Naguszewski et al.,2001)

You may not qualify if:

• Posterior osteophytes
• Spinal canal stenosis
• Rheumatoid arthritis
• Vestibular insufficiency
• Osteoporosis
• Any signs or symptoms of myelopathy
• Any abnormalities of deep sensation
• Associated pathologies of upper cervical region or the upper limb that may cause overlapping with clinical findings as referred pain from costotransverse joint, rotator cuff tendonitis, cervical rib syndrome and entrapment neuropathy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Dokki, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Engy BadrEldin S Moustafa, PhD

  Faculty of Physical Therapy, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engy BadrEldin S Moustafa, PhD

CONTACT

00201099445112; engybm.saleh@cu.edu.eg

Moshera H. Darwish, PhD

CONTACT

00201015163617; dr.moshera11@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients participated will be masked about the type of intervention, where (GA) patients will receive PT program + sham shock wave on upper trapezius, while patients in (GB) will receive focused extracorpeal shock wave on the trigger points of upper trapezius in addition to the same PT program as (GA).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Randomized Controlled Clinical trial, where the recruited patients will be randomly assigned into 2 equal groups ( GA \& GB) using sealed envelopes. Control group (GA) and study group (GB). Patients in (GA) will be treated by a designed physiotherapy program consisted of Myo-facial release, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Median nerve glide techniques ,Graduated strengthening exercises for the upper limb, exercises in addition to sham shock wave on the upper trapezius. Patients in (GB) will be treated by focused Extracorpeal shock wave on the trigger points of upper trapezius in addition to the same physiotherapy program as GA.

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: April 6, 2025
• Primary Completion: November 29, 2025
• Study Completion: January 18, 2026
• Last Updated: October 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)