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

Primary Purpose

Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Denneroll traction
Multimodal Program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation focused on measuring Randomized controlled trial, posture, Kyphosis, Neck Pain

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Traction group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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.
    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
    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)
    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

    Full Information

    First Posted
    May 14, 2021
    Last Updated
    May 14, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04892550
    Brief Title
    Restoring Normal Sagittal Thoracic Posture Improves Management Outcomes in Patients With Chronic Nonspecific Neck Pain
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rehabilitation
    Keywords
    Randomized controlled trial, posture, Kyphosis, Neck Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Traction group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Denneroll traction
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Multimodal Program
    Intervention Description
    The multimodal program consists of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises.
    Primary Outcome Measure Information:
    Title
    Change in thoracic kyphosis
    Description
    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
    Time Frame
    pre-treatment , at 10-week post treatment ,and at 6-month follow up
    Secondary Outcome Measure Information:
    Title
    change in neck disability index
    Description
    The neck disability index to assess activities of daily living impact was administered. The NDI has good reliability, validity, and responsiveness to change
    Time Frame
    pre-treatment , at 10-week post treatment ,and at 6-month follow up
    Title
    Change in numerical rating score
    Description
    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.
    Time Frame
    pre-treatment , at 10-week post treatment ,and at 6-month follow up
    Title
    Change in cervical joint position sense testing
    Description
    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
    Time Frame
    pre-treatment , at 10-week post treatment ,and at 6-month follow up
    Title
    Change in head and eye movement control: smooth pursuit neck torsion test
    Description
    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)
    Time Frame
    pre-treatment , at 10-week post treatment ,and at 6-month follow up
    Title
    Change in Postural Stability
    Description
    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
    Time Frame
    pre-treatment , at 10-week post treatment ,and at 6-month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ibrahim Moustafa, professor
    Phone
    +971502180024
    Email
    iabuamr@sharjah.ac.ae
    First Name & Middle Initial & Last Name or Official Title & Degree
    tamer shousha, professor
    Email
    tshousha@sharjah.ac.ae
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aliaa Diab, professor
    Organizational Affiliation
    Cairo Univeristy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan to make individual participant data (IPD) available to other researchers

    Learn more about this trial

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

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