Impact of Cervical Lordosis Rehabilitation on Autonomic Nervous Function and Cervical Sensorimotor Control
Primary Purpose
Chronic Nonspecific Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Sagittal Cervical Posture Corrective Orthotic Device
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Nonspecific Neck Pain
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.
Sites / Locations
- University of SharjahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention group
Control group
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04306640
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
September 5, 2021 (Anticipated)
Study Completion Date
September 5, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sagittal Cervical Posture Corrective Orthotic Device
Other Intervention Name(s)
Denneroll extension traction
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in radiographic measures of cervical alignment
Description
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.
Time Frame
Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Secondary Outcome Measure Information:
Title
Changes in Neck disability index
Description
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
Time Frame
Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Title
Changes Numerical pain scale
Description
Neck pain average intensity over the past week was assessed using a number scale from 0-10 with higher scores indicating greater pain intensity.
Time Frame
Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Title
changes in Cervical joint position sense testing
Description
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
Time Frame
Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
Title
Changes in Head and eye motor control
Description
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
Time Frame
Measures will be assessed at three time intervals: baseline, after 10 weeks of intervention, and at 1-year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ibrahim M Moustafa, Ass prof
Phone
00971502180024
Ext
7513
Email
iabuamr@sharjah.ac.ae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amina amalmarzouqi, prof
Organizational Affiliation
University of Sharjah
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sharjah
City
Sharjah
ZIP/Postal Code
27272
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amina amalmarzouqi, prof
Ext
7501
Email
amalmarzouqi@sharjah.ac.ae
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33543266
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.
Results Reference
derived
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Impact of Cervical Lordosis Rehabilitation on Autonomic Nervous Function and Cervical Sensorimotor Control
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