Clinical trial NCT05547997: The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy
Official title: The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy: A Randomized Trial With 2-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Lordosis Rehabilitation
Keywords: Cervical spine
Lordosis
Dermatomal
Traction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment A prospective, double blinded, parallel-group, randomized clinical trial will be conducted at one of our university's research departments,
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that improvement of cervical lordosis (CL) in cervical spondylotic radiculopathy (CSR) will improve clinical features in a population suffering from CSR. Thirty chronic lower CSR patients with CL \< 25° will be included. Patients will be assigned randomly into two equal groups, study and control . Both groups will receive neck stretching and exercises and infrared; additionally the study group will receive cervical extension traction. Treatments will be applied 3 time per week for 10 weeks after which groups will be followed for 3-months and 2-years. Amplitude of dermatomal somatosensory evoked potentials (DSSEPS), Cervical lordosis, and pain scales (NRS) will be measured.

Detailed description: Previous studies testing the effects of 3-point bending types of cervical traction, have not clarified exactly what impact the sagittal cervical curve correction has on nerve root function and pain responses associated with improving an abnormal cervical lordosis in cervical spondylotic patients. The present randomized controlled trial will be undertaken to investigate the neurophysiological and pain response outcomes of 3-point bending (2-way) traction compared to standard care in patient cases with lower cervical spine CSR, chronic pain, and with a verified hypo-lordosis of the cervical spine. The primary hypothesis of this study will be that cervical lordosis restoration will have short- and long-term effects on DSSEPs and pain outcomes in CSR patients.

Eligibility criteria: Inclusion Criteria:

* Unilateral radiculopathy due to spondylotic changes of the lower cervical spine
* Absolute rotatory angle is less than 20°
* side to side amplitude differences of 50% or more in dermatomal somatosensory evoked potentials measurement

Exclusion Criteria:

* Central spinal canal stenosis
* Rheumatoid arthritis
* Vestibulobasilar insufficiency
* Osteoporosis
* Inability to tolerate the cervical extension position

Primary outcomes:
measure: The Change in amplitude of dermatomal somatosensory evoked potentials
timeFrame: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
Secondary outcomes:
measure: The change in pain intensity
timeFrame: will be measured at four intervals ;before treatment, after 10 weeks of treatment, at follow up of 3 months and at follow up of 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Ibrahim Moustafa, Professor
role: PRINCIPAL_INVESTIGATOR
References: