Clinical trial NCT04892550: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Keywords: Randomized controlled trial
posture
Kyphosis
Neck Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in thoracic kyphosis
timeFrame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Secondary outcomes:
measure: change in neck disability index
timeFrame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
measure: Change in numerical rating score
timeFrame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
measure: Change in cervical joint position sense testing
timeFrame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
measure: Change in head and eye movement control: smooth pursuit neck torsion test
timeFrame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
measure: Change in Postural Stability
timeFrame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Cairo Univeristy
name: Aliaa Diab, professor
role: STUDY_DIRECTOR
References: