Chronic Neck PainNCT06758232
Neck Education for Parents of Disabled Children
A study testing Exercise in people with Chronic Neck Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Objective: Parents of children with disabilities are at risk of musculoskeletal pain, postural disorders, and functional limitations due to caregiving responsibilities and physical demands. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 3 Nov 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer parents between the ages of 18-65, with spinal problems and chronic pain, pain lasting longer than 3 months, no inflammatory pain, no pain originating from abdominal-pelvic organs will be included in the study.
Who cannot join
- Individuals with acute fractures and malignancies, cervical disc herniation, those who have undergone surgical operations in the cervical region or spine, those with upper extremity pathologies, and those with rheumatological, neurological and psychological disorders will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Neck Education Program in Parents of Children With Disabilities: A Single-Blind Randomized Controlled Trial
Objective: Parents of children with disabilities are at risk of musculoskeletal pain, postural disorders, and functional limitations due to caregiving responsibilities and physical demands. This study aimed to evaluate the effects of a neck education program in parents of children with disabilities who have chronic neck pain.
Method: This single-blind randomized controlled trial included 62 parents diagnosed with chronic neck pain (intervention group: n=30; control group: n=32). The intervention group received a neck education program, while the control group did not receive any training. The program was implemented over five consecutive days and consisted of five 60-minute sessions. Neck pain intensity was assessed using the Visual Analog Scale (VAS) and the Short-Form McGill Pain Questionnaire (SF-MPQ); functional disability using the Neck Disability Index (NDI); spinal curvature using the Spinal Mouse device; posture using the Corbin Posture Assessment Scale (CPAS); physical activity level using the International Physical Activity Questionnaire-Short Form (IPAQ-SF); and quality of life using the SF-36. Assessments were conducted before and 12 weeks after the intervention. Data were analyzed using two-way mixed-design analysis of variance (ANOVA).
Read more
Results: At baseline, no significant differences were found between groups for any parameter (p > 0.05). After the intervention, the intervention group showed a significant improvement in NDI scores (p < 0.001), whereas no significant changes were observed in other parameters (p > 0.05).
Conclusion: The neck education program was found to be effective in reducing functional disability among parents of children with disabilities who experience chronic neck pain.
Keywords: Chronic neck pain; Functional disability; Neck education; Parents of children with disabilities
- Conditions
- Chronic Neck Pain
- Being tested
- Exercise
- Keywords
- Chronic neck pain, Functional disability, Neck education, Parents of children with disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
It will consist of sessions that include neck anatomy, biomechanics, proper posture, ergonomics and neck exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Study Group | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Neck Pain
Visual Analog Scale (VAS): VAS is a measurement generally used to assess pain intensity. VAS is a scale consisting of 10 cm horizontal lines numbered from 0 to 10. The "0" point indicates no pain; the "10" point indicates unbearable pain. The pain intensity felt by caregivers in their spine will be assessed with VAS. Participants will be asked to score the pain intensity felt during rest, activity and sleep between 0 and 10, and the results will be recorded.
Measured: 20 weeks
Assessment of Neck Pain
Mc-Gill Melzack Pain Scale (MMAS): Participants' pain will be measured multidimensionally with MMAS. MMAS consists of 4 sections. The first section includes questions about the area of pain the patient has, the second section evaluates the pain in terms of perception and sensation, the third section includes questions about the relationship between pain and time, and the fourth section includes questions about the severity of pain. The scale is a 4-point Likert-type scale, and each item is scored between 0 and 3 (0: no pain; 3: the most severe pain), and a high total score indicates a high level of pain. The total pain score varies between 0 and 45 (0: no pain; 45: the most severe pain).
Measured: 20 weeks
Neck Disability Assessment
The neck functionality of the participants will be assessed with the Neck Disability Index (NDI), which has validity and reliability. The index, which assesses daily living activities and symptoms, consists of a total of 10 sections. These sections include pain level, personal care, weight bearing, reading, headache, concentration, work life, driving, sleep status and recreational activities. A score between 0-4 is interpreted as no disability, a score between 5-14 is interpreted as mild disability, a score between 15-24 is interpreted as moderate disability, a score between 25-34 is interpreted as severe disability and a score above 35 is interpreted as total disability.
Measured: 20 weeks
Evaluation of Spinal Curvature
Spinal Mouse (SM) is a computer-aided handheld electromechanical device. SM is a measurement tool developed to determine spinal column alignment, segmental and total curvatures, and vertebral motion angles in many planes. SM is a clinically applicable, valid, and objective method. In our study, the Idiag brand SM device will be used. The participants' clothes will be removed and measurements will be made with SM between the C7 (cervical) and S3 (sacral) regions. The data obtained from the measurement will be transferred to the computer via a wireless connection. On the computer, the data will be analyzed via the program and interpreted by the consultant.
Measured: 20 weeks
Posture Evaluation
Posture analysis will be done with the CPAS (Corbin Posture Analysis Scale) prepared by Corbin and his friends. The participant will be evaluated with this scale in the posture analysis table from the lateral and posterior observations. The scale is scored between 0 and 3 (0: none; 3: severe) according to the severity of the disorder. The scores obtained by observing from the posterior and lateral are collected and classified in the final state (Poor ≥12; moderate 8-11; good 5-7; very good 3-4; excellent 0-2).
Measured: 20 weeks
Physical Activity Evaluation
The physical activity level of the participants will be assessed with the International Physical Activity Questionnaire (IFQQ). The scale provides information about the time spent in sitting, walking, moderate and vigorous activities. The participants were asked how many days and how many minutes/hours they did vigorous and moderate exercise, walked and sat in the last 7 days. The criteria for evaluating the activities are based on the fact that each can be done for at least 10 minutes. A value called "MET minutes/week" is obtained by multiplying the minutes, days and metabolic equivalent (MET) values. The physical activity level is classified as physically inactive (<600 MET-min/week), low (minimally active) (600-3000 MET-min/week) and sufficient physical activity level for health (very active) (>3000 MET-min/week).
Measured: 20 weeks
Assessment of Quality of Life
The Short Form-36 Quality of Life Scale (SF-36) will be used to assess quality of life. The scale consists of 8 different sub-dimensions (social function, physical function, emotional role difficulty, physical role difficulty, vitality (energy), pain, mental health, and general health) and a total of 36 items. Sub-groups are evaluated between 0-100 points, and "0 points" indicates poor health status, and "100 points" indicates good health status.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start30 Dec 2024
- Primary completion28 Aug 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atahan TURHAN, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758232
- Sponsor's protocol ID
- KAEU-T.ATAHAN-008
- Status last verified
- Apr 2026
- First submitted
- 26 Dec 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Neck Education Program in Parents of Children With Disabilities: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06758232
- Acronym / sponsor ID
- KAEU-T.ATAHAN-008
- Conditions
- Chronic Neck Pain
- Keywords
- Chronic neck pain, Functional disability, Neck education, Parents of children with disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 3 Jan 2025 (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.
Objective: Parents of children with disabilities are at risk of musculoskeletal pain, postural disorders, and functional limitations due to caregiving responsibilities and physical demands. This study aimed to evaluate the effects of a neck education program in parents of children with disabilities who have chronic neck pain.
Method: This single-blind randomized controlled trial included 62 parents diagnosed with chronic neck pain (intervention group: n=30; control group: n=32). The intervention group received a neck education program, while the control group did not receive any training. The program was implemented over five consecutive days and consisted of five 60-minute sessions. Neck pain intensity was assessed using the Visual Analog Scale (VAS) and the Short-Form McGill Pain Questionnaire (SF-MPQ); functional disability using the Neck Disability Index (NDI); spinal curvature using the Spinal Mouse device; posture using the Corbin Posture Assessment Scale (CPAS); physical activity level using the International Physical Activity Questionnaire-Short Form (IPAQ-SF); and quality of life using the SF-36. Assessments were conducted before and 12 weeks after the intervention. Data were analyzed using two-way mixed-design analysis of variance (ANOVA).
Results: At baseline, no significant differences were found between groups for any parameter (p > 0.05). After the intervention, the intervention group showed a significant improvement in NDI scores (p < 0.001), whereas no significant changes were observed in other parameters (p > 0.05).
Conclusion: The neck education program was found to be effective in reducing functional disability among parents of children with disabilities who experience chronic neck pain.
Keywords: Chronic neck pain; Functional disability; Neck education; Parents of children with disabilities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Study Group | Experimental | Other: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteer parents between the ages of 18-65, with spinal problems and chronic pain, pain lasting longer than 3 months, no inflammatory pain, no pain originating from abdominal-pelvic organs will be included in the study.
Key exclusion criteria (1 listed)
- Individuals with acute fractures and malignancies, cervical disc herniation, those who have undergone surgical operations in the cervical region or spine, those with upper extremity pathologies, and those with rheumatological, neurological and psychological disorders will be excluded from the study.
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 |
|---|---|---|
| ExerciseIt will consist of sessions that include neck anatomy, biomechanics, proper posture, ergonomics and neck exercise training. | Other | Study Group |
Primary outcome
Assessment of Neck Pain
Time frame: 20 weeks
Visual Analog Scale (VAS): VAS is a measurement generally used to assess pain intensity. VAS is a scale consisting of 10 cm horizontal lines numbered from 0 to 10. The "0" point indicates no pain; the "10" point indicates unbearable pain. The pain intensity felt by caregivers in their spine will be assessed with VAS. Participants will be asked to score the pain intensity felt during rest, activity and sleep between 0 and 10, and the results will be recorded.
Assessment of Neck Pain
Time frame: 20 weeks
Mc-Gill Melzack Pain Scale (MMAS): Participants' pain will be measured multidimensionally with MMAS. MMAS consists of 4 sections. The first section includes questions about the area of pain the patient has, the second section evaluates the pain in terms of perception and sensation, the third section includes questions about the relationship between pain and time, and the fourth section includes questions about the severity of pain. The scale is a 4-point Likert-type scale, and each item is scored between 0 and 3 (0: no pain; 3: the most severe pain), and a high total score indicates a high level of pain. The total pain score varies between 0 and 45 (0: no pain; 45: the most severe pain).
Neck Disability Assessment
Time frame: 20 weeks
The neck functionality of the participants will be assessed with the Neck Disability Index (NDI), which has validity and reliability. The index, which assesses daily living activities and symptoms, consists of a total of 10 sections. These sections include pain level, personal care, weight bearing, reading, headache, concentration, work life, driving, sleep status and recreational activities. A score between 0-4 is interpreted as no disability, a score between 5-14 is interpreted as mild disability, a score between 15-24 is interpreted as moderate disability, a score between 25-34 is interpreted as severe disability and a score above 35 is interpreted as total disability.
Evaluation of Spinal Curvature
Time frame: 20 weeks
Spinal Mouse (SM) is a computer-aided handheld electromechanical device. SM is a measurement tool developed to determine spinal column alignment, segmental and total curvatures, and vertebral motion angles in many planes. SM is a clinically applicable, valid, and objective method. In our study, the Idiag brand SM device will be used. The participants' clothes will be removed and measurements will be made with SM between the C7 (cervical) and S3 (sacral) regions. The data obtained from the measurement will be transferred to the computer via a wireless connection. On the computer, the data will be analyzed via the program and interpreted by the consultant.
Posture Evaluation
Time frame: 20 weeks
Posture analysis will be done with the CPAS (Corbin Posture Analysis Scale) prepared by Corbin and his friends. The participant will be evaluated with this scale in the posture analysis table from the lateral and posterior observations. The scale is scored between 0 and 3 (0: none; 3: severe) according to the severity of the disorder. The scores obtained by observing from the posterior and lateral are collected and classified in the final state (Poor ≥12; moderate 8-11; good 5-7; very good 3-4; excellent 0-2).
Physical Activity Evaluation
Time frame: 20 weeks
The physical activity level of the participants will be assessed with the International Physical Activity Questionnaire (IFQQ). The scale provides information about the time spent in sitting, walking, moderate and vigorous activities. The participants were asked how many days and how many minutes/hours they did vigorous and moderate exercise, walked and sat in the last 7 days. The criteria for evaluating the activities are based on the fact that each can be done for at least 10 minutes. A value called "MET minutes/week" is obtained by multiplying the minutes, days and metabolic equivalent (MET) values. The physical activity level is classified as physically inactive (<600 MET-min/week), low (minimally active) (600-3000 MET-min/week) and sufficient physical activity level for health (very active) (>3000 MET-min/week).
Assessment of Quality of Life
Time frame: 20 weeks
The Short Form-36 Quality of Life Scale (SF-36) will be used to assess quality of life. The scale consists of 8 different sub-dimensions (social function, physical function, emotional role difficulty, physical role difficulty, vitality (energy), pain, mental health, and general health) and a total of 36 items. Sub-groups are evaluated between 0-100 points, and "0 points" indicates poor health status, and "100 points" indicates good health status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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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 Exercise in people with Chronic Neck Pain, run by Kirsehir Ahi Evran Universitesi 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of Neck Pain (time frame: 20 weeks). The study lists 7 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 20 Apr 2026.