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Clinical Trials/NCT04892550
NCT04892550
Unknown
Not Applicable

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.

Cairo University0 sites80 target enrollmentMay 2021
ConditionsRehabilitation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rehabilitation
Sponsor
Cairo University
Enrollment
80
Primary Endpoint
Change in thoracic kyphosis
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2021
End Date
October 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Moustafa

Associate professor

Cairo University

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.

Outcomes

Primary Outcomes

Change in thoracic kyphosis

Time Frame: pre-treatment , at 10-week post treatment ,and at 6-month follow up

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 Outcomes

  • change in neck disability index(pre-treatment , at 10-week post treatment ,and at 6-month follow up)
  • Change in Postural Stability(pre-treatment , at 10-week post treatment ,and at 6-month follow up)
  • Change in numerical rating score(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(pre-treatment , at 10-week post treatment ,and at 6-month follow up)
  • Change in cervical joint position sense testing(pre-treatment , at 10-week post treatment ,and at 6-month follow up)

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