Restoring Normal Sagittal Thoracic Posture Improves Management Outcomes in Patients With Chronic Nonspecific Neck Pain

The Addition of a Sagittal Thoracic Posture Corrective Orthotic Device to a Multimodal Rehabilitation Program Improves Management Outcomes in Patients With Chronic Nonspecific Neck Pain: A Randomized-controlled Trial.

Because changes in sagittal thoracic alignment have been reported to alter the mechanical loading of the cervical spine and decreased thoracic mobility has been identified as one of the predictors for neck and shoulder pain , it makes sense that thoracic articular treatment improves local kinematics and simultaneously neck pain improves. The purpose of this study is to investigate the effects of a multimodal program, with thoracic hyper kyphosis rehabilitation using the Denneroll™ thoracic traction orthosis , applied to participants with chronic non-specific neck pain and thoracic hyper-kyphosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation
• Intervention / Treatment: Other: Denneroll traction; Other: Multimodal Program

Detailed Description

Interventions directed at improving hyper-kyphosis of the thoracic spine may have therapeutic effects on the cervical spine; however, there is a lack of controlled studies evaluating this. The purpose of this study is to investigate the effect effects of a multimodal program, with thoracic hyper kyphosis rehabilitation using the Denneroll™ thoracic traction orthosis , applied to participants with chronic non-specific neck pain and thoracic hyper-kyphosis.

In this study, 80 participants, with chronic non-specific neck pain and thoracic hyper-kyphosis will be included. Participants will be randomly assigned to the control or an intervention group. Both groups will receive the multimodal program; additionally, the intervention group received the Denneroll™ thoracic traction orthosis. Outcome measures will include kyphotic angle (max.), neck pain and disability , sensorimotor control outcomes; head repositioning accuracy , smooth pursuit neck torsion test and overall stability index . Measures will be assessed at three intervals: baseline, 10 weeks, and 6 months after cessation of treatment.

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

Contacts and Locations

• Study Contact: Name: Ibrahim Moustafa, professor; Phone Number: +971502180024; Email: iabuamr@sharjah.ac.ae
• Study Contact Backup: Name: tamer shousha, professor; Email: tshousha@sharjah.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• neck pain for more than 3 months
• thoracic angle measured more 55 degrees

Exclusion Criteria:

• Any signs or symptoms of medical "red flags",
• a history of previous spine surgery.
• signs or symptoms of upper motor neuron disease.
• vestibulobasilar insufficiency.
• amyotrophic lateral sclerosis.
• bilateral upper extremity radicular symptoms.

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: Traction group; Participants in both groups will complete a 10-week, 3 x per week, 30 sessions total multimodal program consisting of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises. In addition, the participants in the intervention group will receive the Denneroll™ thoracic traction orthosis. All participants will begin at 3-minutes per session of DTTO application, each visit they will be encouraged to increase the duration by 2-3 minutes, until such time they will be able to reach the goal of 15-20 minutes per session.	Other: Denneroll traction; The participants will be instructed to lie flat on their back on the ground with their knees slightly bent at 20-30° for comfort and arms gently folded across their stomach. The examiner will position the apex of the Denneroll in one of three regions: lower thoracic (T9-T12), mid-thoracic (T5-T8), and upper-thoracic (T1-T4) depending on the apex of each participant's thoracic kyphosis deformity. For lower thoracic kyphosis (T9-T12) the Denneroll is turned 180° so the peak contacts the lower thoracic spine (T10) while the tapered end supports the mid thoracic region; Other: Multimodal Program; The multimodal program consists of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises.
Active Comparator: Control group; Participants in both groups will complete a 10-week, 3 x per week, 30 sessions total multimodal program consisting of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises. The multimodal program will be delivered by the same physiotherapist, with 10 years of experience and training in the specific manual techniques in order to minimize inter-therapist variation and enhance fidelity.	Other: Multimodal Program; The multimodal program consists of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in thoracic kyphosis	Thoracic kyphosis was assessed using a 4D formetric device where determination of thoracic kyphosis angle is measured between tangents from the cervicothoracic junction and that of the thoracolumbar junction	pre-treatment , at 10-week post treatment ,and at 6-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in neck disability index	The neck disability index to assess activities of daily living impact was administered. The NDI has good reliability, validity, and responsiveness to change	pre-treatment , at 10-week post treatment ,and at 6-month follow up
Change in numerical rating score	Neck pain average intensity over the previous week was assessed using a 0-10 numerical rating score where 0 = no pain, …, 10 = bed ridden and incapacitated.	pre-treatment , at 10-week post treatment ,and at 6-month follow up
Change in cervical joint position sense testing	Assessment of head repositioning accuracy with the CROM device is performed in an upright seated posture on a stool with no backrest, the CROM device is placed on the participants head, both feet were firmly on the floor with knees bent at an approximate 90° angle. The neutral head position is established as the beginning and reference positions where the CROM device is adjusted to zero for the primary plane of rotational movement. Individuals will be instructed to close their eyes, memorize the starting position, actively rotate their head 30° about the vertical axis, and reposition their head to the starting position with no requirements for speed; only accuracy was encouraged. HRA is measured as the difference in degrees in the primary plane of movement between the origin and the return positions	pre-treatment , at 10-week post treatment ,and at 6-month follow up
Change in head and eye movement control: smooth pursuit neck torsion test	Electro-oculography will be used for the smooth pursuit neck torsion test to assess disturbances in eye movement control. The test will be performed with the participant's head and trunk in a neutral forward position and then a trunk rotation position (head neutral, trunk in 45° rotation)	pre-treatment , at 10-week post treatment ,and at 6-month follow up
Change in Postural Stability	Postural stability will be evaluated with a Biodex Balance System . Dynamic balance testing will be assessed allowing simultaneous displacements in both the anterior/posterior and medial/lateral directions	pre-treatment , at 10-week post treatment ,and at 6-month follow up

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Aliaa Diab, professor, Cairo Univeristy

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Neck Pain; posture; Kyphosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Cairo 2021-5-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

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