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

NCT ID: NCT04892550

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2022-10-31

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.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Denneroll traction

Intervention Type: 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

Multimodal Program

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Multimodal Program

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Multimodal Program

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Moustafa

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aliaa Diab, professor

Role: STUDY_DIRECTOR

Cairo Univeristy

Central Contacts

Ibrahim Moustafa, professor

Role: CONTACT

iabuamr@sharjah.ac.ae

+971502180024

tamer shousha, professor

Role: CONTACT

tshousha@sharjah.ac.ae

Other Identifiers

Cairo 2021-5-14

Identifier Type: -

Identifier Source: org_study_id