Clinical trial NCT05553002: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Lordosis Rehabilitation
Keywords: lumbosacral radiculopathy
Disc herniation
Cervical lordosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Change in cervical absolute rotatory angle
timeFrame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
measure: The Change in anterior head translation
timeFrame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Secondary outcomes:
measure: The change in 3D spinal posture parameters
timeFrame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
measure: The change in pain intensity
timeFrame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
measure: The change in disability level
timeFrame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
measure: The change in peak to peak amplitude of H reflex
timeFrame: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: University of Sharjah
name: Ibrahim M Moustafa, Professor
role: PRINCIPAL_INVESTIGATOR
References: