Cervical RadiculopathyNCT06102304
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
A study testing Focused Extracorpeal Shock wave in people with Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 46 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Focused Extracorpeal Shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2025to 18 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 36 to 46 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Giza, Dokki, 11432
Engy B. Moustafa, PhD, 00201099445112, engybm.saleh@cu.edu.eg
Moshera H. Darwish, PhD, 00201015163617, dr.moshera11@yahoo.com
About this study
Official title: Effect of Focused Focused Extracorpeal Shock Wave on the Myo-Electrical and Nerve Root Function in Patients With Cervical Radiculopathy
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.
Read the detailed description
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
- Cervical Radiculopathy
- Being tested
- Focused Extracorpeal Shock wave, Sham Extracorpeal shock wave
- Keywords
- Cervical Radiculopathy, Nerve root Dysfunction, Trigger points, Focused Extracorpeal Shock Wave
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Extracorpeal Shock waveDevice
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.
Sham Extracorpeal shock waveDevice
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Focused Extracorpeal Shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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'.
Measured: Baseline Assessment and Immediately Post Treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start6 Apr 2025
- Primary completion29 Nov 2025 (estimated)
- Study completion18 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Badreldin Saleh Moustafa, PhD, Cairo University
- Investigators
- Engy BadrEldin S Moustafa, PhD, Principal investigator, Faculty of Physical Therapy, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102304
- Sponsor's protocol ID
- P.T.REC/012/004747
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Focused Focused Extracorpeal Shock Wave on the Myo-Electrical and Nerve Root Function in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT06102304
- Acronym / sponsor ID
- P.T.REC/012/004747
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical Radiculopathy, Nerve root Dysfunction, Trigger points, Focused Extracorpeal Shock Wave
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 29 Nov 2025 (estimated)
- Study completion
- 18 Jan 2026 (estimated)
- First posted
- 26 Oct 2023 (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.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sham Extracorpeal Shock Wave | Placebo comparator | Device: Sham Extracorpeal shock waveControl 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. |
| Focused Extracorpeal Shock wave | Experimental | Device: Focused Extracorpeal Shock wavePatients 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. |
Who may qualify
- Ages
- 36 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Posterior osteophytes
- Spinal canal stenosis
- Rheumatoid arthritis
- Vestibular insufficiency
- Osteoporosis
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 |
|---|---|---|
| Focused Extracorpeal Shock waveFocused 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. | Device | Focused Extracorpeal Shock wave |
| 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. | Device | Sham Extracorpeal Shock Wave |
Primary outcome
Amplitude of median nerve dermatomal somatosensory evoked potential
Time frame: Baseline Assessment and Immediately Post Treatment.
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)
Distal Latency of median nerve dermatomal somatosensory evoked potential
Time frame: Baseline Assessment and Immediately Post Treatment.
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)
Pain Pressure Threshold on upper trapezius
Time frame: Baseline Assessment and Immediately Post Treatment.
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).
Hand grip Strength
Time frame: Baseline Assessment and Immediately Post Treatment.
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
Level of radiating pain
Time frame: Baseline Assessment and Immediately Post Treatment.
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'.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Engy BadrEldin S Moustafa, PhD principal investigator
Faculty of Physical Therapy, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Extracorpeal Shock wave in people with Cervical Radiculopathy, run by Cairo 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Engy BadrEldin S Moustafa, PhD (00201099445112, engybm.saleh@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of median nerve dermatomal somatosensory evoked potential (time frame: Baseline Assessment and Immediately Post Treatment.). The study lists 5 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 3 Oct 2025.