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

NCT ID: NCT06102304

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-06

Study Completion Date

2026-01-18

Brief Summary

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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.

Detailed Description

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Randomized controlled clinical trial among Forty eight (48) patients with cervical radiculopathy.

They will be allocated randomly by sealed envelopes into two groups: Group (A): will receive a designed physical therapy program in addition to sham Extracorpeal shock wave on upper trapezius. Group (B): will receive Focused Extracorpeal shock wave on the active myofascial trigger points in upper trapezius in addition to the same physical therapy program as in group A.

Somatosensory evoked potential for upper limb median nerve will be applied using the Electromyography (EMG) device. Hand grip strength will be assessed using the handheld dynamometer (HHD) , Level of radiating pain will be assessed using the numeric rating scale , Pain and tenderness in upper trapezius muscle will be also assessed using Pressure pain threshold (PPT).

Conditions

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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).

Study Groups

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Sham Extracorpeal Shock Wave

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.

Group Type PLACEBO_COMPARATOR

Sham Extracorpeal shock wave

Intervention Type 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.

Focused Extracorpeal Shock wave

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.

Group Type EXPERIMENTAL

Focused Extracorpeal Shock wave

Intervention Type 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.

Interventions

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Focused Extracorpeal Shock wave

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.

Intervention Type DEVICE

Sham Extracorpeal shock wave

(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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Posterior osteophytes
2. Spinal canal stenosis
3. Rheumatoid arthritis
4. Vestibular insufficiency
5. Osteoporosis
6. Any signs or symptoms of myelopathy
7. Any abnormalities of deep sensation
8. 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.
Minimum Eligible Age

36 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Engy Badreldin Saleh Moustafa, PhD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Engy BadrEldin S Moustafa, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical Therapy, Cairo University, Egypt

Locations

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Faculty of Physical Therapy, Cairo University

Giza, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Engy BadrEldin S Moustafa, PhD

Role: CONTACT

00201099445112

Moshera H. Darwish, PhD

Role: CONTACT

00201015163617

Facility Contacts

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Engy B. Moustafa, PhD

Role: primary

00201099445112

Moshera H. Darwish, PhD

Role: backup

00201015163617

Other Identifiers

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P.T.REC/012/004747

Identifier Type: -

Identifier Source: org_study_id

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