The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy
Primary Purpose
Cervical Lordosis Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Stretching exercises
Two way traction
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Lordosis Rehabilitation focused on measuring Cervical spine, Lordosis, Dermatomal, Traction
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
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
two way traction
traditional treatment
Arm Description
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
Stretching exercises: Patients will perform the stretching program 3 times a week; with a single session taking about 10 minutes to perform.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The change in pain intensity
Measurement of pain will be performed by using a visual analogue scale (VAS). The subjects will be asked about the perception of pain using a 10-cm line with 0 (no pain) on one end and 10 (worst pain) on the other. subjects will be asked to place a mark along the line to denote their level of pain
Full Information
NCT ID
NCT05547997
First Posted
September 16, 2022
Last Updated
September 16, 2022
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT05547997
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Lordosis Rehabilitation
Keywords
Cervical spine, Lordosis, Dermatomal, Traction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment A prospective, double blinded, parallel-group, randomized clinical trial will be conducted at one of our university's research departments,
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
two way traction
Arm Type
Experimental
Arm Description
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
Arm Title
traditional treatment
Arm Type
Active Comparator
Arm Description
Stretching exercises: Patients will perform the stretching program 3 times a week; with a single session taking about 10 minutes to perform.
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
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
Intervention Name(s)
Two way traction
Intervention Description
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).
Primary Outcome Measure Information:
Title
The Change in amplitude of dermatomal somatosensory evoked potentials
Description
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
Time Frame
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 Outcome Measure Information:
Title
The change in pain intensity
Description
Measurement of pain will be performed by using a visual analogue scale (VAS). The subjects will be asked about the perception of pain using a 10-cm line with 0 (no pain) on one end and 10 (worst pain) on the other. subjects will be asked to place a mark along the line to denote their level of pain
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim Moustafa, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy
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