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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

ibrahim M Moustafa, Ass prof contact

00971502180024 ext. 7513

iabuamr@sharjah.ac.ae

United Arab Emirates1 site, 1 recruiting
  • University of Sharjah

    Sharjah city, 27272

    Amina amalmarzouqi, prof, amalmarzouqi@sharjah.ac.ae

    Recruiting

Other trials in United Arab Emirates

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.

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 groups in NCT04306640
Study groupRoleWhat they receive
intervention groupExperimentalthe 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 groupActive comparatorBoth 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted13 Mar 2020
  2. Study start5 May 2020
  3. Primary completion5 Sep 2021 (estimated)
  4. Study completion5 Sep 2021 (estimated)

Resources

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)
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

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.

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