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

NCT04892550 | Unknown DMC

• 1 other identifier: Cairo 2021-5-14
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rehabilitation

Keywords

Randomized controlled trial; posture; Kyphosis; Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• change in neck disability index

  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 cervical joint position sense testing

  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 Postural Stability

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

Study Arms (2)

Traction group

EXPERIMENTAL

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; Other: Multimodal Program

Control group

ACTIVE COMPARATOR

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

Interventions

Denneroll traction OTHER

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

Traction group

Multimodal Program OTHER

The multimodal program consists of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises.

Control group; Traction group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Kyphosis; Neck Pain

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aliaa Diab, professor

  Cairo Univeristy

  STUDY DIRECTOR

Central Study Contacts

Ibrahim Moustafa, professor

CONTACT

+971502180024; iabuamr@sharjah.ac.ae

tamer shousha, professor

CONTACT

tshousha@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

Model Details: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: May 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share