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

NCT04306640 | Unknown DMC

• 1 other identifier: University of Sharjah
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Nonspecific Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in Neck disability index

  Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up

• Changes Numerical pain scale

  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

  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

  Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up

Study Arms (2)

intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Sagittal Cervical Posture Corrective Orthotic Device OTHER

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

Also known as: Denneroll extension traction

Control group; intervention group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, 27272, United Arab Emirates

RECRUITING

Related Publications (1)

• 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.

  PMID: 33543266 DERIVED

Study Officials

• Amina amalmarzouqi, prof

  University of Sharjah

  STUDY CHAIR

Central Study Contacts

ibrahim M Moustafa, Ass prof

CONTACT

00971502180024; iabuamr@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 13, 2020
• Study Start: May 5, 2020
• Primary Completion: September 5, 2021
• Study Completion: September 5, 2021
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)