RehabilitationNCT04892550
Restoring Normal Sagittal Thoracic Posture Improves Management Outcomes in Patients With Chronic Nonspecific Neck Pain
A study testing Denneroll traction and Multimodal Program in people with Rehabilitation, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Denneroll traction and Multimodal Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- neck pain for more than 3 months
- thoracic angle measured more 55 degrees
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
tamer shousha, professor contact
About this study
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.
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.
Read the 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
- Being tested
- Denneroll traction, Multimodal Program
- Keywords
- Randomized controlled trial, posture, Kyphosis, Neck Pain
- Medical subject headings
- Kyphosis, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denneroll tractionOther
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 ProgramOther
The multimodal program consists of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Multimodal Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Secondary outcomes (5)
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
Measured: pre-treatment , at 10-week post treatment ,and at 6-month follow up
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.
Measured: pre-treatment , at 10-week post treatment ,and at 6-month follow up
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
Measured: 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
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)
Measured: pre-treatment , at 10-week post treatment ,and at 6-month follow up
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
Measured: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study startMay 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, Cairo University
- Investigators
- Aliaa Diab, professor, Study director, Cairo Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892550
- Sponsor's protocol ID
- Cairo 2021-5-14
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04892550
- Acronym / sponsor ID
- Cairo 2021-5-14
- Conditions
- Rehabilitation
- Keywords
- Randomized controlled trial, posture, Kyphosis, Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
| Arm | Type | Receives |
|---|---|---|
| Traction group | Experimental | Other: Denneroll traction, Other: Multimodal ProgramParticipants 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. |
| Control group | Active comparator | Other: Multimodal ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- neck pain for more than 3 months
- thoracic angle measured more 55 degrees
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denneroll tractionThe 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 | Other | Traction group |
| Multimodal ProgramThe multimodal program consists of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises. | Other | Control group, Traction group |
Primary outcome
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
5 secondary outcomes
change in neck disability index
Time frame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Change in numerical rating score
Time frame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Change in cervical joint position sense testing
Time frame: 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
Time frame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Change in Postural Stability
Time frame: pre-treatment , at 10-week post treatment ,and at 6-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No. no plan to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tamer shousha, professor contact
Aliaa Diab, professor study director
Cairo Univeristy
Questions about this trial
What is this clinical trial studying?
A study testing Denneroll traction and Multimodal Program in people with Rehabilitation, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Moustafa, professor (+971502180024, iabuamr@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in thoracic kyphosis (time frame: pre-treatment , at 10-week post treatment ,and at 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.