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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age36-46
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Posterior osteophytes

Spinal canal stenosis

Rheumatoid arthritis

Vestibular insufficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Sham Extracorpeal Shock WavePlacebo comparator 1 intervention
Group B: Focused Extracorpeal Shock waveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline Assessment and Immediately Post Treatment.
2

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)

Time frame
Baseline Assessment and Immediately Post Treatment.
3

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).

Time frame
Baseline Assessment and Immediately Post Treatment.
4

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

Time frame
Baseline Assessment and Immediately Post Treatment.

Secondary outcomes

Other outcomes

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