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

Cairo University (CU)

Status: Enrolling

Conditions: Cervical Radiculopathy

Treatments: Device: Sham Extracorpeal shock wave; Device: Focused Extracorpeal Shock wave

Study type: Interventional

Funder types: Other

Identifiers

NCT06102304

P.T.REC/012/004747

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 36 to 46 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Sham Extracorpeal Shock Wave

Placebo Comparator group

Description:

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.

Treatment:

Device: Sham Extracorpeal shock wave

Focused Extracorpeal Shock wave

Experimental group

Description:

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.

Treatment:

Device: Focused Extracorpeal Shock wave