Chronic Nonspecific Neck PainNCT04306640
Impact of Cervical Lordosis Rehabilitation on Autonomic Nervous Function and Cervical Sensorimotor Control
A study testing Sagittal Cervical Posture Corrective Orthotic Device in people with Chronic Nonspecific Neck Pain, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
Objective: To investigate the immediate and long-term effects of cervical lordosis restoration and anterior head translation (AHT) correction, on pain, disability, autonomic nervous system function and cervical sensorimotor control in Athletes with Chronic nonspecific neck pain. Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Chronic Nonspecific Neck Pain
- What is being tested?
- Sagittal Cervical Posture Corrective Orthotic Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 5 May 2020to 5 Sep 2021
- 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 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- chronic neck pain (i.e. of more than 3 months duration)
- AHT distance more than 25 mm .
- ARA C2-C7 less than 20°
Who cannot join
- signs or symptoms of systemic pathology .
- inflammatory joint disease.
- prior history of cervical spine trauma and musculoskeletal system surgery.
- disorders related to the spine and extremities.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
University of Sharjah
Sharjah city, 27272
Amina amalmarzouqi, prof, amalmarzouqi@sharjah.ac.ae
About this study
Official title: Demonstration of Autonomic Nervous Function and Cervical Sensorimotor Control After Cervical Lordosis Rehabilitation: A Randomized-controlled Trial
Objective: To investigate the immediate and long-term effects of cervical lordosis restoration and anterior head translation (AHT) correction, on pain, disability, autonomic nervous system function and cervical sensorimotor control in Athletes with Chronic nonspecific neck pain.
Methods: 110 (51 female) chronic nonspecific neck patients with a defined hypolordotic cervical spine and AHT posture will be randomly assigned to the control or an experimental group. Both groups will receive a multi-modal program; additionally, the experimental group will receive the denneroll™ cervical traction. Interventions will be applied 3 x per week for 10 weeks. Outcome measures will include absolute rotatory angle (ARA), AHT, neck disability index (NDI), pain intensity, smooth pursuit neck torsion test (SPENT), overall stability index , left and right rotation repositioning accuracy , amplitude and latency of skin sympathetic response . Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up.
Read the detailed description
The study is a randomized, single-blind trial. Measurements will be obtained before the randomization, after the intervention period of 10 weeks, and at 12 months. Recruitment will begin following institutional review board approval. The patients will participate in the study after signing an informed consent form prior to data collection. Patients will be included if they were 18 years of age or over; had chronic neck pain (i.e. of more than 3 months duration[19] ; able to attend a full course of 30 treatments, given three times a week. Cervical lordosis measurements (absolute rotation angle ARA C2-C7 using the angle of intersection of two lines drawn along the posterior vertebral body margins of C2 and C7, respectively) were used as a screen for participants' inclusion. [20][21][22] The anterior head translation (AHT) was measured from the posterior superior body of C2 to the vertical line passing through the posterior inferior body of C7. AHT distance had to exceed 25 mm and ARA C2-C7 had to be less than 20° [20] for subjects to be included. Participants were excluded if they presented with any of the following: (i) signs or symptoms of systemic pathology and inflammatory joint disease; (ii) prior history of cervical spine trauma and musculoskeletal system surgery, or disorders related to the spine and extremities. An independent person will assign participants at random to a traditional (control) treatment group (55) or to the intervention group (55). A random number generator was used to select numbers from sealed envelopes. Randomization was conducted through permuted blocks of diverse sizes. These blocks were used to generate a sequence of successively numbered, opaque, sealed envelopes that were kept in a locked drawer. The next envelope in the sequence will be opened by the researcher in the presence of the participant.
Both the intervention group and the traditional treatment group will complete a multimodal program of 10 weeks consisting of myofascial release, thoracic spine mobilization and manipulations, and physical pain relief methods. Additionally, the intervention group will receive the denneroll cervical traction orthotic in an attempt to improve the altered sagittal cervical spine alignment (AHT and ARA C2-C7). The first follow up evaluations will be conducted at the end of the 10-weeks (30 sessions) multimodal program while the second follow up was conducted 1 year after finishing the 10-weeks intervention program.
P All the intervention program will be delivered individually by the same physiotherapist, who has received certified training in these manual techniques in order to minimize inter-therapist variation and enhance fidelity.
- Conditions
- Chronic Nonspecific Neck Pain
- Being tested
- Sagittal Cervical Posture Corrective Orthotic Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagittal Cervical Posture Corrective Orthotic DeviceOther
Also called Denneroll extension traction
The subjects in the traction group will receive the deneroll extension traction. The subjects will be asked to lie supine on the ground with their legs straight, upper arms by their sides and forearms gently folded across their trunk. The therapist will place the apex of the denneroll either in the mid cervical region or the lower cervical region depending on the apex of cervical curvature deformity of each subject. Initially, participants begin with three minutes of sustained denneroll extension traction and progressed to the goal of 20 min per session with one to two additional minutes per session
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | the intervention group will receive the denneroll cervical traction orthotic in an attempt to improve the altered sagittal cervical spine alignment (AHT and ARA C2-C7). Receives: Other: Sagittal Cervical Posture Corrective Orthotic Device |
| Control group | Active comparator | Both the intervention group and the control group will complete a multimodal program of 10 weeks consisting of myofascial release, thoracic spine mobilization and manipulations, and physical pain relief methods. Receives: Other: Sagittal Cervical Posture Corrective Orthotic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in radiographic measures of cervical alignment
ARA C2-C7 is the angle of intersection of two lines drawn along the posterior vertebral body margins of C2 and C7, respectively) The anterior head translation (AHT) was measured from the posterior superior body of C2 to the vertical line passing through the posterior inferior body of C7.
Measured: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Secondary outcomes (4)
Changes in Neck disability index
Neck disability index consists of 10 items inquiring about standard daily activities. The responsiveness to change, construct validity, and reliability have been adequately investigated in a variety of patient populations The test can be interpreted as a raw score, with a maximum score of 50.A higher score indicates more patient-rated disability
Measured: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Changes Numerical pain scale
Neck pain average intensity over the past week was assessed using a number scale from 0-10 with higher scores indicating greater pain intensity.
Measured: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
changes in Cervical joint position sense testing
Assessment of head repositioning accuracy (HRA) with a cervical range of motion (CROM) device will be done according to existing investigations . Participants will be placed in upright neutral seated posture on a stool with no back rest with their feet touching the ground; where their perceived natural head position (NHP) was determined and used as the reference neutral point. The CROM device will be positioned to 0, 0, 0 for x, y, and z rotational displacements. With their eyes closed, participants will be asked to remember their NHP as the starting posture, and then actively rotate their head 30° to the left about the vertical y-axis and then reposition their head back the NHP
Measured: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Changes in Head and eye motor control
The smooth pursuit neck torsion test (SPNT) will be administered using an Electro-oculography device, to quantify any alteration and improvement in visual motor control
Measured: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start5 May 2020
- Primary completion5 Sep 2021 (estimated)
- Study completion5 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonspecific Neck PainStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, University of Sharjah
- Investigators
- Amina amalmarzouqi, prof, Study chair, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306640
- Sponsor's protocol ID
- University of Sharjah
- Status last verified
- Jun 2020
- First submitted
- 8 Mar 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moustafa I, Youssef ASA, Ahbouch A, Harrison D. Demonstration of Autonomic Nervous Function and Cervical Sensorimotor Control After Cervical Lordosis Rehabilitation: A Randomized Controlled Trial. J Athl Train. 2021 Apr 1;56(4):427-436. doi: 10.4085/1062-6050-0481.19.
PubMed 33543266
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of Autonomic Nervous Function and Cervical Sensorimotor Control After Cervical Lordosis Rehabilitation: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04306640
- Acronym / sponsor ID
- University of Sharjah
- Conditions
- Chronic Nonspecific Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 5 Sep 2021 (estimated)
- Study completion
- 5 Sep 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
Objective: To investigate the immediate and long-term effects of cervical lordosis restoration and anterior head translation (AHT) correction, on pain, disability, autonomic nervous system function and cervical sensorimotor control in Athletes with Chronic nonspecific neck pain.
Methods: 110 (51 female) chronic nonspecific neck patients with a defined hypolordotic cervical spine and AHT posture will be randomly assigned to the control or an experimental group. Both groups will receive a multi-modal program; additionally, the experimental group will receive the denneroll™ cervical traction. Interventions will be applied 3 x per week for 10 weeks. Outcome measures will include absolute rotatory angle (ARA), AHT, neck disability index (NDI), pain intensity, smooth pursuit neck torsion test (SPENT), overall stability index , left and right rotation repositioning accuracy , amplitude and latency of skin sympathetic response . Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up.
Detailed description
The study is a randomized, single-blind trial. Measurements will be obtained before the randomization, after the intervention period of 10 weeks, and at 12 months. Recruitment will begin following institutional review board approval. The patients will participate in the study after signing an informed consent form prior to data collection. Patients will be included if they were 18 years of age or over; had chronic neck pain (i.e. of more than 3 months duration[19] ; able to attend a full course of 30 treatments, given three times a week. Cervical lordosis measurements (absolute rotation angle ARA C2-C7 using the angle of intersection of two lines drawn along the posterior vertebral body margins of C2 and C7, respectively) were used as a screen for participants' inclusion. [20][21][22] The anterior head translation (AHT) was measured from the posterior superior body of C2 to the vertical line passing through the posterior inferior body of C7. AHT distance had to exceed 25 mm and ARA C2-C7 had to be less than 20° [20] for subjects to be included. Participants were excluded if they presented with any of the following: (i) signs or symptoms of systemic pathology and inflammatory joint disease; (ii) prior history of cervical spine trauma and musculoskeletal system surgery, or disorders related to the spine and extremities. An independent person will assign participants at random to a traditional (control) treatment group (55) or to the intervention group (55). A random number generator was used to select numbers from sealed envelopes. Randomization was conducted through permuted blocks of diverse sizes. These blocks were used to generate a sequence of successively numbered, opaque, sealed envelopes that were kept in a locked drawer. The next envelope in the sequence will be opened by the researcher in the presence of the participant.
Both the intervention group and the traditional treatment group will complete a multimodal program of 10 weeks consisting of myofascial release, thoracic spine mobilization and manipulations, and physical pain relief methods. Additionally, the intervention group will receive the denneroll cervical traction orthotic in an attempt to improve the altered sagittal cervical spine alignment (AHT and ARA C2-C7). The first follow up evaluations will be conducted at the end of the 10-weeks (30 sessions) multimodal program while the second follow up was conducted 1 year after finishing the 10-weeks intervention program.
P All the intervention program will be delivered individually by the same physiotherapist, who has received certified training in these manual techniques in order to minimize inter-therapist variation and enhance fidelity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Sagittal Cervical Posture Corrective Orthotic Devicethe intervention group will receive the denneroll cervical traction orthotic in an attempt to improve the altered sagittal cervical spine alignment (AHT and ARA C2-C7). |
| Control group | Active comparator | Other: Sagittal Cervical Posture Corrective Orthotic DeviceBoth the intervention group and the control group will complete a multimodal program of 10 weeks consisting of myofascial release, thoracic spine mobilization and manipulations, and physical pain relief methods. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- chronic neck pain (i.e. of more than 3 months duration)
- AHT distance more than 25 mm .
- ARA C2-C7 less than 20°
Key exclusion criteria (4 listed)
- signs or symptoms of systemic pathology .
- inflammatory joint disease.
- prior history of cervical spine trauma and musculoskeletal system surgery.
- disorders related to the spine and extremities.
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 |
|---|---|---|
| Sagittal Cervical Posture Corrective Orthotic DeviceAlso: Denneroll extension tractionThe subjects in the traction group will receive the deneroll extension traction. The subjects will be asked to lie supine on the ground with their legs straight, upper arms by their sides and forearms gently folded across their trunk. The therapist will place the apex of the denneroll either in the mid cervical region or the lower cervical region depending on the apex of cervical curvature deformity of each subject. Initially, participants begin with three minutes of sustained denneroll extension traction and progressed to the goal of 20 min per session with one to two additional minutes per session | Other | Control group, intervention group |
Primary outcome
Changes in radiographic measures of cervical alignment
Time frame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
ARA C2-C7 is the angle of intersection of two lines drawn along the posterior vertebral body margins of C2 and C7, respectively) The anterior head translation (AHT) was measured from the posterior superior body of C2 to the vertical line passing through the posterior inferior body of C7.
4 secondary outcomes
Changes in Neck disability index
Time frame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Changes Numerical pain scale
Time frame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
changes in Cervical joint position sense testing
Time frame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Changes in Head and eye motor control
Time frame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 33543266Moustafa I, Youssef ASA, Ahbouch A, Harrison D. Demonstration of Autonomic Nervous Function and Cervical Sensorimotor Control After Cervical Lordosis Rehabilitation: A Randomized Controlled Trial. J Athl Train. 2021 Apr 1;56(4):427-436. doi: 10.4085/1062-6050-0481.19.
- Individual participant dataSharing planned: No
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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.
Amina amalmarzouqi, prof study chair
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sagittal Cervical Posture Corrective Orthotic Device in people with Chronic Nonspecific Neck Pain, run by University of Sharjah at 1 site in United Arab Emirates.
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 3 inclusion and 4 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
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 M Moustafa, Ass prof (00971502180024 ext. 7513, iabuamr@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in radiographic measures of cervical alignment (time frame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04306640, which also lists 1 linked publication.
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 16 Jun 2020.