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

Cervical Radiculopathy Clinical Trial

Official title:

Effect of Focused Focused Extracorpeal Shock Wave on the Myo-Electrical and Nerve Root Function in Patients With Cervical Radiculopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102304
• Other study ID #: P.T.REC/012/004747
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Engy BadrEldin S Moustafa, PhD
• Phone: 00201099445112
• Email: engybm.saleh[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cervical radiculopathy.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: July 10, 2024
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Years to 46 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Giza	Ad Doqi, Giza District, Giza Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.