- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06236737
Sensorimotor Exercises and Neurodevelopmental Yoga in Chronic Neck Pain
January 24, 2024 updated by: Dilanur Özkaraoğlu, PT, MSc, Medipol University
Comparison of Sensorimotor and Yoga Exercise in Patients With Chronic Neck Pain
Neck pain is an important public health problem with a high lifetime prevalence and frequently occurring in all industrialized countries.
Clinical practice guidelines for chronic neck pain recommend conservative management.
Conservative treatment includes many approaches such as endurance, stretching and strengthening exercises, manual therapy, proprioceptive exercises, pilates and yoga.
In patients with chronic neck pain, atrophy of deep neck muscles, deterioration in fiber type ratio, muscle tenderness and decreased range of motion are observed.
These problems cause poor cervical postural control system and thus impaired sense of proprioception, loss of balance, decreased eye movement and cervical muscle activity.
Sensorimotor control of upright posture and head-eye movement relies on information from the vestibular, visual, and proprioceptive systems that assemble throughout the central nervous system.The cervical spine has an important role in providing proprioceptive input.
This role is associated with an abundance of cervical mechanoreceptors.
Recent studies have shown that proprioceptive training is associated with cervical joint position sense, joint range of motion, pain and disability.
Also yoga combines physical exercises with breathing techniques and meditation and yoga is one of the most commonly used complementary treatments for neck pain.The aim of study is to determine the effectiveness of exercises for sensorimotor structure and yoga exercises with physical and meditative effects in individuals with chronic neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants diagnosed with chronic neck pain will be randomly divided into two groups as sensorimotor exercise group and yoga group by the evaluator.
Sensorimotor exercise group; oculomotor exercise to provide information from the visual system, laser target exercise to provide information from the proprioception system, and postural stability exercise to provide information from the vestibular system.
Yoga group will be given yoga exercises.
Within the content of oculomotor exercise, gaze stability exercise and head-body coordination exercise will be given to the participants.
Laser target exercise will be given with the laser target fixed on the participant's head and 90 cm away from the target.
Postural stability exercise will be given in form of tandem exercise and standing on one leg.
Yoga exercises will be applied by changing and combining 14 poses every week.
The study will take 8 weeks.
Participants in both groups will also be treated for 2 days a week.
Participants will be evaluated twice, before and after treatment.
Participants will be evaluated with Demographic Information Form, SF-36 Quality of Life Scale, Neck Disability Questionnaire, Tampa Kinesiophobia Scale, Numerical Pain Scale, Joint Range of Motion Measurement (G-Pro), Joint Position Error Test.
Data analysis of the study will be done using SPSS 22.0 package program.
The difference between Independent Groups will be compared with the Student's-t independent Test.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey, 34100
- Istanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- aged 24-60 years of either sex, at least a 12 weeks history of CNP, CNP according to the Quebec Task Force grading system in Grade 1 and 2
Exclusion Criteria:
- according to Quebec Task Force grading system Grade 3 and 4 neck pain, neurological defects, speech and perception disorders, psychiatric diagnosis, recent history of neck trauma, recent history of cancer, diagnosed vestibular disorder, participants who diagnosed eye disorders, recent history of surgery, contraindications to yoga.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensorimotor Exercise Group
Sensorimotor exercise group; oculomotor exercise to provide information from the visual system, laser target exercise to provide information from the proprioception system, and postural stability exercise to provide information from the vestibular system.
Within the scope of oculomotor exercise, gaze stability exercise and head-body coordination exercise will be given to the participants.
Laser target exercise will be given with the laser target fixed on the participant's head and 90 cm away from the target.
Postural stability exercise will be given in the form of tandem exercise and standing on one leg.
|
The sensorimotor group was given oculomotor, gaze stability and postural stability exercises.
Each session lasted 40 minutes in total.
|
|
Experimental: Yoga Exercise Group
Yoga group will be given yoga exercises including 14 poses.
These exercises are: bridge pose, corpse pose, bharadvaja's twist, downward facing dog, downward facing hero, extended side angle, extended triangle, mountain pose, prosperous pose, reclining big toe, standing half forward bend, thunderbolt pose, upward hand
|
A flow was created for the yoga group.
Each session lasting 40 minutes was included ocular motor, balance, meditation and stretching.
Practices illustrated in table one were repeated for the eight weeks.
Beginning of each session was focused on breathing exercises and the yoga flow is designed.
Weeks 1-2.
were prepared by focusing mostly on sagittal plane asanas.
While 3-5.
tweeks were focused on frontal plane asanas, 6-8.
weeks were focused on transvers plan.
Each session commenced with a 5-minute practice of a three dimensional breathing technique.
This was followed by a 25-minute yoga asana flow, concluding with a 10-minute meditation in shavasana, also known as Corpse Pose.
NDY was taught by an academician physiotherapist who has completed graduation in yoga therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Joint Position Error Test
Time Frame: 8 weeks
|
Cervical joint position error (JPE) test was used a laser pointer.
A laser pointer was mounted onto a lightweight headband is then placed on the patient's head.
The patient was sut 90 cm from the wall, and the started point (center of target or reference point) of the laser projection was marked.
The participant (blindfolded or closed) performed active neck movement and then returned to the starting position as accurately as possible.
The final laser position was measured relative to the starting position (distance or angle).
The errors was measured after cervical extension, flexion, lateral flexions, and rotations.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion (ROM)
Time Frame: 8 weeks
|
ROM was measured using the G-pro app installed on the iPhone 13.
The examiner activated the G-pro app and pressed the "device axis" button to adjust the axis according to the test condition.
For measuring flexion and extension, the iPhone was placed just beside the external auditory meatus and one axis of the app was aligned with the imaginary line between the base of the nostril and the external auditory meatus.
Active lateral flexion ROM was measured in the sitting position.
The center of the app was placed over the C7 spinous process, and one axis of the app was aligned with the occipital protuberance.
Finally, because of difficulty in using the app for measuring active cervical rotation in sitting, this movement was evaluated in the supine position.
The center of the app was positioned at the center of the head and one axis was aligned with the nose.
|
8 weeks
|
|
Numerical Pain Rating Scale (NPRS)
Time Frame: 8 weeks
|
The 11-point numerical pain rating scale (NPRS) is a measure of pain in which participants rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain),1-4 and it has been shown to have concurrent and predictive validity as a measure of pain intensity.
The NPRS is as a valuable and dependable assessment tool that significantly complements comprehensive research and practices related to neck pain.
|
8 weeks
|
|
Neck Disability Index (NDI)
Time Frame: 8 weeks
|
The NDI has 10 questions scored on a Likert scale (0 to 5), with higher total scores out of 50 indicating greater levels of perceived difficulty with activities of daily living due to neck pain.
The NDI is a commonly used clinical outcome measure with good internal consistency and good construct validity
|
8 weeks
|
|
Tampa Scale for Kinesiophobia (TSK)
Time Frame: 8 weeks
|
The TSK is a reliable and valid measurement tool that provides therapists valuable information on activity avoidance and pathological somatic focus in patients with musculoskeletal pain.
It is a 17-questions scale calculated with Likert scoring and includes the parameters of re-injury and fear in work-related activities.
The scoring is; "I strongly disagree" is 1, "I disagree" is 2, "I agree" is 3, "I strongly agree" is 4. A total score is calculated after reversing the fourth, eighth, twelfth and sixteenth items.
A higher score on the scale indicates a higher level of kinesiophobia.
|
8 weeks
|
|
Quality of Life (Short Form-36)
Time Frame: 8 weeks
|
The quality of life questionnaire (SF-36) was used to evaluate the patients' life quality with a mental and physical score.
The SF-36 has been also used to test the correlation between health-related quality of life and related factors (sex, age, physical function, and daily functioning) rated on a 5-point scale.
It consists of 36 items and 8 scales, including physical function, physical role, body pain, general health, vitality, social behavior, emotional role, and mental health.
The obtained scores range between 0 and 100 with higher scores indicating better health status.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dilanur Kutlu Özkaraoğlu, MsC, Istanbul MedipolUniversity
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
January 24, 2024
First Submitted That Met QC Criteria
January 24, 2024
First Posted (Estimated)
February 1, 2024
Study Record Updates
Last Update Posted (Estimated)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MedipolU-FTR-DO-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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