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

NCT05553002 | Completed DMC

• 1 other identifier: Cairo-11-2-15
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Lordosis Rehabilitation

Keywords

lumbosacral radiculopathy; Disc herniation; Cervical lordosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The change in 3D spinal posture parameters

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

• The change in pain intensity

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

• The change in disability level

  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

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

Study Arms (2)

Deneroll cervical extension traction

EXPERIMENTAL

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; Other: Traditional treatment

Traditional treatment

ACTIVE COMPARATOR

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

Interventions

Deneroll cervical extension traction OTHER

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: 1. In the upper cervical region (C2-C4) region. 2. The apex of the Denneroll orthotic is placed in the mid-cervical region (C4-C6) region. 3. The apex of the Denneroll orthotic is placed in the upper thoracic lower-cervical region (C6-T1) region.

Deneroll cervical extension traction

Traditional treatment OTHER

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

Deneroll cervical extension traction; Traditional treatment

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ibrahim M Moustafa, Professor

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-chair of Physiotherapy Department

Model Details: 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

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: December 12, 2012
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)