The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy

NCT ID: NCT05547997

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-03-01

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.

Conditions

Cervical Lordosis Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

two way traction

The study group will receive 3-point bending cervical extension traction following the protocol of Harrison et al. The duration of each session will starte at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session

Group Type: EXPERIMENTAL

Stretching exercises

Intervention Type: OTHER

Exercises will be performed in the following order: 1) stretching towards lateral flexion for the upper part of the trapezius; 2) ipsilateral flexion and rotation for the scalene; 3) and flexion for the extensor muscles. Each maneuver will be held for 30 seconds as this is an optimum time to not create alteration in the evoked protentional. Each stretch will be repeated 3 times

Two way traction

Intervention Type: OTHER

During the traction, the head halter will be fixed posteriorly to cause slight distraction, retraction, and slight extension and at the same time a front anterior strap had weight will be applied over a pulley that allows transverse traction load to be applied to the apex of the participants cervical curve alteration. Weights will start at 15 lbs. (6.8 Kg) on the anterior strap and will increase over consecutive visits to patient tolerance or a maximum of 35 lbs. (15.9 Kg).

traditional treatment

Stretching exercises: Patients will perform the stretching program 3 times a week; with a single session taking about 10 minutes to perform.

Group Type: ACTIVE_COMPARATOR

Stretching exercises

Intervention Type: OTHER

Exercises will be performed in the following order: 1) stretching towards lateral flexion for the upper part of the trapezius; 2) ipsilateral flexion and rotation for the scalene; 3) and flexion for the extensor muscles. Each maneuver will be held for 30 seconds as this is an optimum time to not create alteration in the evoked protentional. Each stretch will be repeated 3 times

Interventions

Stretching exercises

Exercises will be performed in the following order: 1) stretching towards lateral flexion for the upper part of the trapezius; 2) ipsilateral flexion and rotation for the scalene; 3) and flexion for the extensor muscles. Each maneuver will be held for 30 seconds as this is an optimum time to not create alteration in the evoked protentional. Each stretch will be repeated 3 times

Intervention Type: OTHER

Two way traction

During the traction, the head halter will be fixed posteriorly to cause slight distraction, retraction, and slight extension and at the same time a front anterior strap had weight will be applied over a pulley that allows transverse traction load to be applied to the apex of the participants cervical curve alteration. Weights will start at 15 lbs. (6.8 Kg) on the anterior strap and will increase over consecutive visits to patient tolerance or a maximum of 35 lbs. (15.9 Kg).

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Moustafa

Professor-chair of Physiotherapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ibrahim Moustafa, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Cairo-20-18-4

Identifier Type: -

Identifier Source: org_study_id