Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Focused Extracorpeal Shock wave, Sham Extracorpeal shock wave.
- Who it may be relevant to
- Registry conditions: Cervical Radiculopathy. Basic parameters: 36 years — 46 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Focused Focused Extracorpeal Shock Wave on the Myo-Electrical and Nerve Root Function in Patients With Cervical Radiculopathy
Overview
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).
Interventions
- 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. - 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.
Primary outcome measures
- Amplitude of median nerve dermatomal somatosensory evoked potential [Time frame: Baseline Assessment and Immediately Post Treatment.]
- Distal Latency of median nerve dermatomal somatosensory evoked potential [Time frame: Baseline Assessment and Immediately Post Treatment.]
- Pain Pressure Threshold on upper trapezius [Time frame: Baseline Assessment and Immediately Post Treatment.]
- Hand grip Strength [Time frame: Baseline Assessment and Immediately Post Treatment.]
- Level of radiating pain [Time frame: Baseline Assessment and Immediately Post Treatment.]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Physical Therapy, Cairo University — Giza
Identifiers
NCT: NCT06102304 · P.T.REC/012/004747