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Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy

Primary Purpose

Cervical Lordosis Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Deneroll cervical extension traction
Traditional treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Lordosis Rehabilitation focused on measuring lumbosacral radiculopathy, Disc herniation, Cervical lordosis

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Absolute rotatory angle less than 25° and greater than 0.
  • Anterior head translation distance greater than 15mm
  • Confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse .
  • Symptoms lasting longer than 3 months

Exclusion Criteria:

  • Previous history of lumbosacral surgery.
  • Metabolic system disorder.
  • Peripheral neuropathy.
  • History of upper motor neuron lesion.
  • Spinal canal stenosis.
  • Rheumatoid arthritis.
  • Osteoporosis

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deneroll cervical extension traction

Traditional treatment

Arm Description

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

The participants will receive hot packs (15 minutes) and TENS therapy to control pain and eliminate the causal role of muscle spasms and/or tightness in changing the posture parameters.

Outcomes

Primary Outcome Measures

The Change in cervical absolute rotatory angle
Cervical absolute rotatory angle is formed by two lines intersecting from the posterior body margins of C2-C7 and forward head distance
The Change in anterior head translation
anterior head translation is measured as the horizontal displacement of the posterior superior body corner of C2 vertebra relative to a vertical line extending superiorly from the posterior inferior body corner of C7..

Secondary Outcome Measures

The change in 3D spinal posture parameters
Rasterstereography sagittal plane parameters (lumbar angles, thoracic angles, and trunk inclination), the frontal plane parameters (trunk imbalance and lateral deviation) and the transversal plane parameters (vertebral surface rotation and pelvis torsion) will be selected to cover the posture profile in three planes
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
The change in disability level
Disability will be measured using the Oswestry Disability Index. The total score is transferred onto a scale ranging from 0 to 100, where 0 indicates no disability and 100 indicates worst possible disability
The change in peak to peak amplitude of H reflex
The H-reflex (or Hoffmann's reflex) is a reaction of muscles after electrical stimulation of sensory fibers (Ia afferents stemming from muscle spindles) in their innervating nerves

Full Information

First Posted
September 21, 2022
Last Updated
September 21, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05553002
Brief Title
Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy
Official Title
Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2011 (Actual)
Primary Completion Date
May 1, 2012 (Actual)
Study Completion Date
December 12, 2012 (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
A randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . Participants will include 80 patients between 40 and 55 years experiencing chronic discogenic lumbosacral radiculopathy with a definite hypolordotic cervical spine and forward head posture and will be randomly assigned a comparative treatment control group and a study group. Both groups will receive TENS therapy and hot packs, additionally, the study group will receive the Denneroll cervical traction orthotic.
Detailed Description
Despite the fact that there is some evidence of a link between low back pain and head posture , there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. Accordingly, a prospective, randomized, controlled study will be conducted at a research laboratory of our university to investigate if cervical curve restoration and forward head posture correction will have short and long term effects on three dimensional spinal posture parameters as well as lumbar radiculopathy management outcomes such as symptoms, disability, and neurophysiological findings .In this study we will use an orthotic cervical traction termed the Denneroll to help restore normal sagittal spinal configuration based on principles of 3-point bending traction methods. Interventions will be applied at a frequency of 3 times per week for 10 weeks and groups will be followed for an additional 6-months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Lordosis Rehabilitation
Keywords
lumbosacral radiculopathy, Disc herniation, Cervical lordosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized, controlled study will be conducted at a research laboratory of our university. Participants will be randomly assigned to to either the treatment group or the control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deneroll cervical extension traction
Arm Type
Experimental
Arm Description
The study group will receive 3-point bending cervical extension traction following the protocol of Deed Harrison . The duration of each session will start 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
The participants will receive hot packs (15 minutes) and TENS therapy to control pain and eliminate the causal role of muscle spasms and/or tightness in changing the posture parameters.
Intervention Type
Other
Intervention Name(s)
Deneroll cervical extension traction
Intervention Description
Participants will lie flat on their back on the ground with their legs extended and arms by their sides. The denneroll will placed on the ground and positioned in the posterior aspect of the neck depending on the area to be addressed . The apex of the Denneroll orthotic will be placed in one of three regions based on lateral cervical radiographic displacements: In the upper cervical region (C2-C4) region. The apex of the Denneroll orthotic is placed in the mid-cervical region (C4-C6) region. The apex of the Denneroll orthotic is placed in the upper thoracic lower-cervical region (C6-T1) region.
Intervention Type
Other
Intervention Name(s)
Traditional treatment
Intervention Description
The participants will receive hot packs (15 minutes) and TENS therapy .During TENS application. Patients will be asked to adopt a prone position. The TENS therapy will be delivered at the lumbosacral region for 20 min. The frequency will set to 80 Hz and pulse width to 50 µs due to its analgesic effect . These conventional treatments will be repeated three times per week over the course of 10 weeks for 30 total sessions
Primary Outcome Measure Information:
Title
The Change in cervical absolute rotatory angle
Description
Cervical absolute rotatory angle is formed by two lines intersecting from the posterior body margins of C2-C7 and forward head distance
Time Frame
will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Title
The Change in anterior head translation
Description
anterior head translation is measured as the horizontal displacement of the posterior superior body corner of C2 vertebra relative to a vertical line extending superiorly from the posterior inferior body corner of C7..
Time Frame
will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Secondary Outcome Measure Information:
Title
The change in 3D spinal posture parameters
Description
Rasterstereography sagittal plane parameters (lumbar angles, thoracic angles, and trunk inclination), the frontal plane parameters (trunk imbalance and lateral deviation) and the transversal plane parameters (vertebral surface rotation and pelvis torsion) will be selected to cover the posture profile in three planes
Time Frame
will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
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 three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Title
The change in disability level
Description
Disability will be measured using the Oswestry Disability Index. The total score is transferred onto a scale ranging from 0 to 100, where 0 indicates no disability and 100 indicates worst possible disability
Time Frame
will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Title
The change in peak to peak amplitude of H reflex
Description
The H-reflex (or Hoffmann's reflex) is a reaction of muscles after electrical stimulation of sensory fibers (Ia afferents stemming from muscle spindles) in their innervating nerves
Time Frame
will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Absolute rotatory angle less than 25° and greater than 0. Anterior head translation distance greater than 15mm Confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse . Symptoms lasting longer than 3 months Exclusion Criteria: Previous history of lumbosacral surgery. Metabolic system disorder. Peripheral neuropathy. History of upper motor neuron lesion. Spinal canal stenosis. Rheumatoid arthritis. Osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim M Moustafa, Professor
Organizational Affiliation
University of Sharjah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy

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