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

Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Cervical Lordosis Rehabilitation
• Intervention / Treatment: Other: Deneroll cervical extension traction; Other: Traditional treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deneroll cervical extension traction; 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	Other: Deneroll cervical extension traction; 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.; Other: Traditional treatment; 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
Active Comparator: Traditional treatment; 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.	Other: Traditional treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
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..	will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
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	will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
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	will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
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	will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ibrahim M moustafa, Professor, University of Sharjah

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): December 12, 2012

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Disc herniation; lumbosacral radiculopathy; Cervical lordosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Nutrition Disorders; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Deficiency Diseases; Malnutrition; Spinal Diseases; Bone Diseases; Spinal Curvatures; Radiculopathy; Lordosis; Swayback
• Other Study ID Numbers: Cairo-11-2-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No