Impact of Cervical Lordosis Rehabilitation on Autonomic Nervous Function and Cervical Sensorimotor Control

Demonstration of Autonomic Nervous Function and Cervical Sensorimotor Control After Cervical Lordosis Rehabilitation: A Randomized-controlled Trial

Objective: To investigate the immediate and long-term effects of cervical lordosis restoration and anterior head translation (AHT) correction, on pain, disability, autonomic nervous system function and cervical sensorimotor control in Athletes with Chronic nonspecific neck pain.

Methods: 110 (51 female) chronic nonspecific neck patients with a defined hypolordotic cervical spine and AHT posture will be randomly assigned to the control or an experimental group. Both groups will receive a multi-modal program; additionally, the experimental group will receive the denneroll™ cervical traction. Interventions will be applied 3 x per week for 10 weeks. Outcome measures will include absolute rotatory angle (ARA), AHT, neck disability index (NDI), pain intensity, smooth pursuit neck torsion test (SPENT), overall stability index , left and right rotation repositioning accuracy , amplitude and latency of skin sympathetic response . Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up.

Study Overview

• Status: Unknown
• Conditions: Chronic Nonspecific Neck Pain
• Intervention / Treatment: Other: Sagittal Cervical Posture Corrective Orthotic Device

Detailed Description

The study is a randomized, single-blind trial. Measurements will be obtained before the randomization, after the intervention period of 10 weeks, and at 12 months. Recruitment will begin following institutional review board approval. The patients will participate in the study after signing an informed consent form prior to data collection. Patients will be included if they were 18 years of age or over; had chronic neck pain (i.e. of more than 3 months duration[19] ; able to attend a full course of 30 treatments, given three times a week. Cervical lordosis measurements (absolute rotation angle ARA C2-C7 using the angle of intersection of two lines drawn along the posterior vertebral body margins of C2 and C7, respectively) were used as a screen for participants' inclusion. [20][21][22] The anterior head translation (AHT) was measured from the posterior superior body of C2 to the vertical line passing through the posterior inferior body of C7. AHT distance had to exceed 25 mm and ARA C2-C7 had to be less than 20° [20] for subjects to be included. Participants were excluded if they presented with any of the following: (i) signs or symptoms of systemic pathology and inflammatory joint disease; (ii) prior history of cervical spine trauma and musculoskeletal system surgery, or disorders related to the spine and extremities. An independent person will assign participants at random to a traditional (control) treatment group (55) or to the intervention group (55). A random number generator was used to select numbers from sealed envelopes. Randomization was conducted through permuted blocks of diverse sizes. These blocks were used to generate a sequence of successively numbered, opaque, sealed envelopes that were kept in a locked drawer. The next envelope in the sequence will be opened by the researcher in the presence of the participant.

Both the intervention group and the traditional treatment group will complete a multimodal program of 10 weeks consisting of myofascial release, thoracic spine mobilization and manipulations, and physical pain relief methods. Additionally, the intervention group will receive the denneroll cervical traction orthotic in an attempt to improve the altered sagittal cervical spine alignment (AHT and ARA C2-C7). The first follow up evaluations will be conducted at the end of the 10-weeks (30 sessions) multimodal program while the second follow up was conducted 1 year after finishing the 10-weeks intervention program.

P All the intervention program will be delivered individually by the same physiotherapist, who has received certified training in these manual techniques in order to minimize inter-therapist variation and enhance fidelity.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ibrahim M Moustafa, Ass prof; Phone Number: 7513 00971502180024; Email: iabuamr@sharjah.ac.ae

Study Locations

• United Arab Emirates
  • Sharjah, United Arab Emirates, 27272
    • Recruiting
    • University of Sharjah
    • Contact: Amina amalmarzouqi, prof; Email: amalmarzouqi@sharjah.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic neck pain (i.e. of more than 3 months duration)
• AHT distance more than 25 mm .
• ARA C2-C7 less than 20°

Exclusion Criteria:

• signs or symptoms of systemic pathology .
• inflammatory joint disease.
• prior history of cervical spine trauma and musculoskeletal system surgery.
• disorders related to the spine and extremities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; the intervention group will receive the denneroll cervical traction orthotic in an attempt to improve the altered sagittal cervical spine alignment (AHT and ARA C2-C7).	Other: Sagittal Cervical Posture Corrective Orthotic Device; The subjects in the traction group will receive the deneroll extension traction. The subjects will be asked to lie supine on the ground with their legs straight, upper arms by their sides and forearms gently folded across their trunk. The therapist will place the apex of the denneroll either in the mid cervical region or the lower cervical region depending on the apex of cervical curvature deformity of each subject. Initially, participants begin with three minutes of sustained denneroll extension traction and progressed to the goal of 20 min per session with one to two additional minutes per session; Other Names: Denneroll extension traction
Active Comparator: Control group; Both the intervention group and the control group will complete a multimodal program of 10 weeks consisting of myofascial release, thoracic spine mobilization and manipulations, and physical pain relief methods.	Other: Sagittal Cervical Posture Corrective Orthotic Device; The subjects in the traction group will receive the deneroll extension traction. The subjects will be asked to lie supine on the ground with their legs straight, upper arms by their sides and forearms gently folded across their trunk. The therapist will place the apex of the denneroll either in the mid cervical region or the lower cervical region depending on the apex of cervical curvature deformity of each subject. Initially, participants begin with three minutes of sustained denneroll extension traction and progressed to the goal of 20 min per session with one to two additional minutes per session; Other Names: Denneroll extension traction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in radiographic measures of cervical alignment	ARA C2-C7 is the angle of intersection of two lines drawn along the posterior vertebral body margins of C2 and C7, respectively) The anterior head translation (AHT) was measured from the posterior superior body of C2 to the vertical line passing through the posterior inferior body of C7.	Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Neck disability index	Neck disability index consists of 10 items inquiring about standard daily activities. The responsiveness to change, construct validity, and reliability have been adequately investigated in a variety of patient populations The test can be interpreted as a raw score, with a maximum score of 50.A higher score indicates more patient-rated disability	Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Changes Numerical pain scale	Neck pain average intensity over the past week was assessed using a number scale from 0-10 with higher scores indicating greater pain intensity.	Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
changes in Cervical joint position sense testing	Assessment of head repositioning accuracy (HRA) with a cervical range of motion (CROM) device will be done according to existing investigations . Participants will be placed in upright neutral seated posture on a stool with no back rest with their feet touching the ground; where their perceived natural head position (NHP) was determined and used as the reference neutral point. The CROM device will be positioned to 0, 0, 0 for x, y, and z rotational displacements. With their eyes closed, participants will be asked to remember their NHP as the starting posture, and then actively rotate their head 30° to the left about the vertical y-axis and then reposition their head back the NHP	Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Changes in Head and eye motor control	The smooth pursuit neck torsion test (SPNT) will be administered using an Electro-oculography device, to quantify any alteration and improvement in visual motor control	Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up

Collaborators and Investigators

• Sponsor: University of Sharjah
• Investigators: Study Chair: Amina amalmarzouqi, prof, University of Sharjah

Publications and helpful links

General Publications

• Moustafa I, Youssef ASA, Ahbouch A, Harrison D. Demonstration of Autonomic Nervous Function and Cervical Sensorimotor Control After Cervical Lordosis Rehabilitation: A Randomized Controlled Trial. J Athl Train. 2021 Apr 1;56(4):427-436. doi: 10.4085/1062-6050-0481.19.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Anticipated): September 5, 2021
• Study Completion (Anticipated): September 5, 2021

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Neck Pain; Lordosis
• Other Study ID Numbers: University of Sharjah (Other Identifier: University of Sharjah)

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