Clinical trial NCT04306640: Impact of Cervical Lordosis Rehabilitation on Autonomic Nervous Function and Cervical Sensorimotor Control
Official title: Demonstration of Autonomic Nervous Function and Cervical Sensorimotor Control After Cervical Lordosis Rehabilitation: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Nonspecific Neck Pain
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 110
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* chronic neck pain (i.e. of more than 3 months duration)
* AHT distance more than 25 mm .
* ARA C2-C7 less than 20°

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in radiographic measures of cervical alignment
timeFrame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Secondary outcomes:
measure: Changes in Neck disability index
timeFrame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
measure: Changes Numerical pain scale
timeFrame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
measure: changes in Cervical joint position sense testing
timeFrame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
measure: Changes in Head and eye motor control
timeFrame: Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University of Sharjah
Study officials:
affiliation: University of Sharjah
name: Amina amalmarzouqi, prof
role: STUDY_CHAIR
References:
citation: 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.