Clinical trial NCT06102304: Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Official title: Effect of Focused Focused Extracorpeal Shock Wave on the Myo-Electrical and Nerve Root Function in Patients With Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical Radiculopathy
Nerve root Dysfunction
Trigger points
Focused Extracorpeal Shock Wave
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 36
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Amplitude of median nerve dermatomal somatosensory evoked potential
timeFrame: Baseline Assessment and Immediately Post Treatment.
measure: Distal Latency of median nerve dermatomal somatosensory evoked potential
timeFrame: Baseline Assessment and Immediately Post Treatment.
measure: Pain Pressure Threshold on upper trapezius
timeFrame: Baseline Assessment and Immediately Post Treatment.
measure: Hand grip Strength
timeFrame: Baseline Assessment and Immediately Post Treatment.
measure: Level of radiating pain
timeFrame: Baseline Assessment and Immediately Post Treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Dokki
Study officials:
affiliation: Faculty of Physical Therapy, Cairo University, Egypt
name: Engy BadrEldin S Moustafa, PhD
role: PRINCIPAL_INVESTIGATOR
References: