Chronic PainNCT05496127
Sensorimotor Exercises Practice and Yoga in Chronic Neck Pain
A study testing Sensorimotor Exercises and Yoga in people with Chronic Pain and Neck Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Neck Pain
- What is being tested?
- Sensorimotor Exercises and Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 15 Aug 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with chronic neck pain at Grade 1 and 2 level,
- Being over 18 years old,
- Pain lasting more than 3 months,
- Absence of neurogenic deficit
Who cannot join
- Having been diagnosed with chronic neck pain at Grade 3 and 4 level,
- Having problems with speaking and understanding,
- Having undergone surgery on the neck region,
- Having a history of trauma,
- Having a history of cancer,
- Diagnosis of vestibular disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34100
About this study
Official title: Two Different Approaches in Patients With Chronic Neck Pain: Sensorimotor Exercises Practice and Yoga
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.
Read the detailed description
Inclusion criteria for the study were: having a diagnosis of 'chronic neck pain', being over the age of 18, persistence of pain for more than 3 months, no neurogenic deficit, and agreeing to participate in the study. Exclusion criteria from the study are as follows: Having speech and comprehension problems, undergoing surgery on the neck region, having a history of trauma and cancer, and a diagnosis of vestibular disorder. After the analysis of the GPower 3.1 program to decide on the sample size, it was seen that a total of 50 participants should be included in the study for a statistical power of 82% (alpha:0.05). 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.
- Conditions
- Chronic Pain, Neck Pain
- Being tested
- Sensorimotor Exercises and Yoga
- Medical subject headings
- Chronic Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor Exercises and YogaOther
Within the content of sensorimotor exercise; oculomotor exercise, laser target exercise and postural stability exercise were applied. 14 yoga poses were applied within the content of Yoga Exercises.
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor Exercise Group | Experimental | 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. Receives: Other: Sensorimotor Exercises and Yoga |
| Yoga Exercise Group | Experimental | 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 pose, warrior pose II. Receives: Other: Sensorimotor Exercises and Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 36 Quality of Life Scale
SF-36 assesses quality of life by focusing on the physical, social and spiritual components of health. It consists of 36 items. Each item is scored between 0-100. 100 points indicate good health, 0 points poor health.
Measured: Change in quality of life at 8 weeks
The Neck Disability Index
The Neck Disability Index is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. Pain severity, personal care, concentration, driving, headache, lifting, working, sleeping, recretion, reading are questioned. This questionnaire consists of 10 questions, each question is given 0-5 points, and the higher the score, the higher the degree of disability. While 50 points is the highest possible score, 0 points is the lowest.
Measured: Change in functionality at 8 weeks
Tampa Kinesiophobia Scale
Tampa Kinesiophobia Scale is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
Measured: Change in fear of movement at 8 weeks
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults with chronic pain. NPRS is a segmented numeric version of the visual analog scale in which selects a whole number (0-10 integers) that best reflects the intensity of patients pain. An NPRS score of 3 and less than 3 represents low pain, 4-6 represents moderate pain, and greater than 7 represents severe pain.
Measured: Change in pain intensity at 8 weeks
Joint Range of Motion Measurement
Joint movements of the cervical region are performed using clinical instruments such as goniometer and cervical joint range of motion device. With the innovations brought by technology opportunities, different applications have been started to be used in the measurement of joint range of motion. The application named 'G-Pro' has good reliability and high validity in measuring active cervical joint range of motion in nonspecific neck pain participants. Participants will be evaluated with the G-Pro application. Values that should be in a healthy individual; 45-65 degrees for flexion, 45-50 degrees for extension, 55 degrees for rotation, and 40 degrees for lateral flexion.
Measured: Change in range of motion at 8 weeks
Joint Position Error Test
The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting. The target is 90x80 cm in diameter. A laser pointer device is placed on the patient's head. The patient is then asked to focus on finding natural resting head position so that the laser pointer is in line with the centre. With eyes closed, the patient will actively move their head in one plane of motion and attempt to return to the starting position as accurately as possible. The patient should verbally indicate when they feel they have returned to the starting position. The distance of this point from the origin is measured. The more deteriorated the joint position sense is, the higher the value will be.
Measured: Change in joint position sense at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Dec 2020
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilanur Özkaraoğlu, PT, MSc, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496127
- Sponsor's protocol ID
- E-10840098-772.02-34229
- Status last verified
- Aug 2022
- First submitted
- 19 Jul 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Different Approaches in Patients With Chronic Neck Pain: Sensorimotor Exercises Practice and Yoga
- ClinicalTrials.gov ID
- NCT05496127
- Acronym / sponsor ID
- E-10840098-772.02-34229
- Conditions
- Chronic Pain, Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 11 Aug 2022 (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.
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.
Detailed description
Inclusion criteria for the study were: having a diagnosis of 'chronic neck pain', being over the age of 18, persistence of pain for more than 3 months, no neurogenic deficit, and agreeing to participate in the study. Exclusion criteria from the study are as follows: Having speech and comprehension problems, undergoing surgery on the neck region, having a history of trauma and cancer, and a diagnosis of vestibular disorder. After the analysis of the GPower 3.1 program to decide on the sample size, it was seen that a total of 50 participants should be included in the study for a statistical power of 82% (alpha:0.05). 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor Exercise Group | Experimental | Other: Sensorimotor Exercises and YogaSensorimotor 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. |
| Yoga Exercise Group | Experimental | Other: Sensorimotor Exercises and YogaYoga 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 pose, warrior pose II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with chronic neck pain at Grade 1 and 2 level,
- Being over 18 years old,
- Pain lasting more than 3 months,
- Absence of neurogenic deficit
Key exclusion criteria (6 listed)
- Having been diagnosed with chronic neck pain at Grade 3 and 4 level,
- Having problems with speaking and understanding,
- Having undergone surgery on the neck region,
- Having a history of trauma,
- Having a history of cancer,
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 |
|---|---|---|
| Sensorimotor Exercises and YogaWithin the content of sensorimotor exercise; oculomotor exercise, laser target exercise and postural stability exercise were applied. 14 yoga poses were applied within the content of Yoga Exercises. | Other | Sensorimotor Exercise Group, Yoga Exercise Group |
Primary outcome
Short Form 36 Quality of Life Scale
Time frame: Change in quality of life at 8 weeks
SF-36 assesses quality of life by focusing on the physical, social and spiritual components of health. It consists of 36 items. Each item is scored between 0-100. 100 points indicate good health, 0 points poor health.
The Neck Disability Index
Time frame: Change in functionality at 8 weeks
The Neck Disability Index is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. Pain severity, personal care, concentration, driving, headache, lifting, working, sleeping, recretion, reading are questioned. This questionnaire consists of 10 questions, each question is given 0-5 points, and the higher the score, the higher the degree of disability. While 50 points is the highest possible score, 0 points is the lowest.
Tampa Kinesiophobia Scale
Time frame: Change in fear of movement at 8 weeks
Tampa Kinesiophobia Scale is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
Numeric Pain Rating Scale
Time frame: Change in pain intensity at 8 weeks
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults with chronic pain. NPRS is a segmented numeric version of the visual analog scale in which selects a whole number (0-10 integers) that best reflects the intensity of patients pain. An NPRS score of 3 and less than 3 represents low pain, 4-6 represents moderate pain, and greater than 7 represents severe pain.
Joint Range of Motion Measurement
Time frame: Change in range of motion at 8 weeks
Joint movements of the cervical region are performed using clinical instruments such as goniometer and cervical joint range of motion device. With the innovations brought by technology opportunities, different applications have been started to be used in the measurement of joint range of motion. The application named 'G-Pro' has good reliability and high validity in measuring active cervical joint range of motion in nonspecific neck pain participants. Participants will be evaluated with the G-Pro application. Values that should be in a healthy individual; 45-65 degrees for flexion, 45-50 degrees for extension, 55 degrees for rotation, and 40 degrees for lateral flexion.
Joint Position Error Test
Time frame: Change in joint position sense at 8 weeks
The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting. The target is 90x80 cm in diameter. A laser pointer device is placed on the patient's head. The patient is then asked to focus on finding natural resting head position so that the laser pointer is in line with the centre. With eyes closed, the patient will actively move their head in one plane of motion and attempt to return to the starting position as accurately as possible. The patient should verbally indicate when they feel they have returned to the starting position. The distance of this point from the origin is measured. The more deteriorated the joint position sense is, the higher the value will be.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor Exercises and Yoga in people with Chronic Pain and Neck Pain, run by Medipol University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 15 Aug 2022. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form 36 Quality of Life Scale (time frame: Change in quality of life at 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2022.