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

Not Applicable

Recruiting

• Conditions: Cervical Radiculopathy
• Interventions: Device: Focused Extracorpeal Shock wave; Device: Sham Extracorpeal shock wave

• Registration Number: NCT06102304
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-26
• Status Verified: 2024-05
• Study Start: 2024-06-06
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-01-19
• Study Completion: 2025-01-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focused Extracorpeal Shock wave	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.
Sham Extracorpeal Shock Wave	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.

Primary Outcome Measures

Name	Time	Method
Level of radiating pain	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'.
Amplitude of median nerve dermatomal somatosensory evoked potential	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	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	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	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

Trial Locations

Locations (1)

Faculty of Physical Therapy, Cairo University; 🇪🇬 Giza, Ad Doqi, Giza District, Giza Governorate, Egypt