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

NCT05547997 | Completed DMC

• 1 other identifier: Cairo-20-18-4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Lordosis Rehabilitation

Keywords

Cervical spine; Lordosis; Dermatomal; Traction

Outcome Measures

Primary Outcomes (1)

• The Change in amplitude of dermatomal somatosensory evoked potentials

  In all dermatomes, two complete recording runs will be undertaken during each session, with averages of 250-1,200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C6, C7, and C8 dermatomes being stimulated

  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 (1)

• The change in pain intensity

  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

Study Arms (2)

two way traction

EXPERIMENTAL

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

Other: Stretching exercises; Other: Two way traction

traditional treatment

ACTIVE COMPARATOR

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

Other: Stretching exercises

Interventions

Stretching exercises 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

traditional treatment; two way traction

Two way traction 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).

two way traction

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lordosis

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ibrahim Moustafa, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor who will conduct the measurements will be blinded. Assessor blinding will be obtained through an independent research assistant not knowing the study design and not specifically involved in any aspect of the trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-chair of Physiotherapy Department

Model Details: Parallel Assignment A prospective, double blinded, parallel-group, randomized clinical trial will be conducted at one of our university's research departments,

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)