Chronic PainNCT05943587
The Development and Evaluation of Pain Neuroscience Education in Children
A study testing culture-sensitive PNE4kids and standard education in people with Chronic Pain and Child, Only, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The International Association for the Study of Pain and The International Classification of Diseases (ICD) 11 define chronic pain as pain lasting more than 3 months, regardless of the cause. For children and adolescents, chronic pain is an extremely terrible and suffering problem. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Chronic Pain, Child, Only
- What is being tested?
- culture-sensitive PNE4kids and standard education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 16 May 2024
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 8 years and 12 years;
- Diagnosed with chronic pain (at least three months of pain and a pain frequency of three or more days per week)
- Those who do not take analgesics 48 hours prior to study evaluations.
Who cannot join
- Patients with unmanageable psychological disorders (e.g., attention deficit hyperactivity disorder, autistic spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.
- Patients who started a new treatment during the trial or 6 weeks before to the study for chronic pain.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University
Antalya
Ozgun KAYA KARA, Assoc. Prof., ozgunkara@akdeniz.edu.tr
ceren Gursen, Assoc.Prof
About this study
Official title: The Development and Evaluation of Culturally Sensitive Pain Neuroscience Education in Children With Chronic Pain
The International Association for the Study of Pain and The International Classification of Diseases (ICD) 11 define chronic pain as pain lasting more than 3 months, regardless of the cause. For children and adolescents, chronic pain is an extremely terrible and suffering problem. Periods of persistent pain negatively affect the child's participation in school and recreational activities, leading to academic problems and social exclusion. Moreover, children are at increased risk of experiencing chronic pain problems in adulthood. Because of these difficulties children with chronic pain should be treated as soon as possible. Pain Neuroscience Education (PNE) is an educational approach used in chronic pain rehabilitation. The purpose of PNE is to change individual's perception of pain. The most fundamental and crucial aspect of PNE is educating patients about the underlying causes of their pain. The primary purpose of the project is to conduct a modified Delphi survey to obtain and synthesize expert opinions on PNE materials. The second aim of this study is to investigate the effect of PNE on pain, quality of life and participation in children with chronic pain and compare it with the standard treatment program.
Read the detailed description
Chronic pain is not directly cause death but it is a major source of disability and suffering. Because of the enormous medical, economic, and social burden of chronic pain worldwide better understanding of pain biology has become a critical topic in order to develop targeted, novel, safe, and effective treatments. Pain Neuroscience Education (PNE) is a multidisciplinary educational method used by physiotherapists worldwide in chronic pain rehabilitation. The goal of PNE is to alter a person's perception of pain. PNE aims to correct patient misconceptions about pain physiology. As a result, pain education can help to reduce levels of fear of pain, fear of movement, pain catastrophizing thoughts, and passive coping strategies (for example, the use of painkillers or massage treatments). Currently, only a few research have investigated the benefits of PNE in children. The majority of studies have focused on pain management education programs rather than explaining the neurology of pain. The combined effects of PNE and physiotherapy have not been studied in children. But adult studies are demonstrated that PNE and physiotherapy are effective. According to studies, PNE has been linked to promising results in the treatment of chronic pain and functional impairment in adults. James et al. concluded that PNE reduced pain, disability, pain catastrophization, and kinesiophobia in the short and medium term, based on a systematic evaluation of 12 randomized controlled studies assessing the effect of PNE in individuals with chronic musculoskeletal pain. Currently, no study has been conducted in investigators country that has adapted PNE for children and evaluated the consequences of PNE use. The primary aim of the research is to perform a modified Delphi survey to obtain and synthesize expert opinions on culturally appropriate PNE materials for children in terms of content, relevance of information, clarity and intelligibility of information, and visual qualities of the materials. The second aim of the research is to investigate the impacts of culturally tailored PNE on pain symptoms (pain severity, pain awareness, fear of pain, catastrophizing pain, dealing with pain), quality of life, and involvement in children with chronic pain, as well as to compare it to a normal education program.
- Conditions
- Chronic Pain, Child, Only
- Being tested
- culture-sensitive PNE4kids, standard education
- Keywords
- Chronic Pain, Children, Pain Neuroscience Education, Physical Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture-sensitive PNE4kidsOther
Culturally adapted PNE4kids used by physiotherapists worldwide in chronic pain rehabilitation.
standard educationOther
Standard education used by physiotherapists worldwide in chronic pain rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain group | Experimental | 30-45 minute individual sessions of culture-sensitive PNE4kids training will be applied. Receives: Other: culture-sensitive PNE4kids |
| Control Group | Active comparator | 30-45 minute individual sessions of standard education training will be applied. Receives: Other: standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Scale
It is a valid and reliable scale preferred by children and their families to evaluate the severity of pain. It consists of 6 facial expressions that symbolize the severity of pain. These show the stages of increased pain from a smiling face (0 points) to a very sad and crying face (10 points). The meaning of each facial expression is carefully explained to the child. Children rate pain intensity according to face shapes.It consists of 6 facial expressions that symbolize the severity of the pain. It is scored between 0-10. Increasing scores indicate more pain.
Measured: change from baseline to end of the 1 week and 4 weeks
Pain Vigilance and Awareness Questionnaire Child & Adult Version
Pain Vigilance and Awareness Questionnaire Child evaluates children's attention to pain. There are 14 items on the scale. A 0-5 likert scale is used for scoring. It has a rating of 0 (never) to 5 (always) (always). The total score is calculated by multiplying the individual item scores. Pain Vigilance and Awareness Questionnaire-Adult uses 16 items to test adults' attention and pain awareness. It has ten items for paying attention and six ones for being aware. A 0-5 likert scale is used for scoring. 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always, and 5 = always. The scale's eighth and sixteenth items are scored in reverse order. The scaled total score ranges from 0 to 80. Higher ratings suggest that you are more conscious of your pain.Items are rated on a 6-point scale, ranging from 0 (never) to 5 (always). The 8th and 16th items of the scale are reverse scored. The scale total score is obtained between 0-80. Higher scores indicate greater awareness of pain.
Measured: change from baseline to end of the 1 week and 4 weeks
Fear of Pain Questionnaire for Children/Parents
The Fear of Pain Questionnaire for Children-Short Form is a 10-item version of the 24-item Fear of Pain Questionnaire for Children. It uses children's self-reports to assess pain-related fears (4 items) and avoidance behaviours (6 items). A 0-4 Likert scale is used for scoring. A score of 0 indicates strong disagreement, while a score of 5 indicates strong agreement.Items are summed to derive a total score (with between 0-40) . Higher scores indicate higher pain-related fear and avoidance behaviors.
Measured: change from baseline to end of the 1 week and 4 weeks
Pain Catastrophizing Scale- Child
Crombez et al. created the Pain Catastrophizing Scale-Child, an adaptation of the Pain Catastrophizing Scale for children. Catastrophizing behaviours is evaluated with 13 items: rumination (4 items), magnification (3 items), and helplessness (6 items). The scoring is done on a 0-4 point Likert scale. It is evaluated on a scale of 0 (not at all) to 4 (very extremely).Items are summed to derive a total score (with between 0-52), with higher scores indicating more pain catastrophizing.
Measured: change from baseline to end of the 1 week and 4 weeks
Functional Disability Inventory
Walker and Greene developed the Functional Disability Inventory to assess challenges faced by school-age children and adolescents in executing activities of daily living from the child's perspective. There are 15 items in Functional Disability Inventory. Each item asks about how many physical challenges or obstacles the youngster has experienced while executing the activity in the previous few days. The scoring is done on a 0-4 point Likert scale. It is ranked between 0 (no problem) and 4 (impossible). Items are summed to derive a total score (with between 0-60) , with higher total scores indicating greater disability.
Measured: change from baseline to end of the 1 week and 4 weeks
Pain Coping Questionnaire
Evaluates the coping strategies of children and adolescents with a total of 39 items in 8 subscales. These are seeking knowledge, problem solving, seeking social support, positive self-suggestion, behavioural distraction, cognitive distraction, externalization, and internalization/catastrophizing. Items are assessed on a 5-point Likert scale, with 1 indicating never and 5 indicating very often. Higher ratings indicate higher use of coping strategy. PCQ consists of parent and adolescent form.The scores for each subscale are calculated by averaging the items. Higher scores indicate that the child uses strategies to cope more frequently.
Measured: change from baseline to end of the 1 week and 4 weeks
Secondary outcomes (2)
Participation and Environment- Children and Youth
The participation sections included 10 activities in the home setting, five activities in the school setting, and 10 in the community setting. For each activity, the range of participation is daily to never, with scores between 0 and 8; higher scores indicate greater participation. The range of involvement is from very involved to minimally involved, with scores between 1 and 5; higher scores indicate greater involvement. The range of whether change is desired in the child's participation in this kind of activity is no or yes, with scores between 0 and 1. Environmental features supports and barriers (e.g., do the features of the environment help or make it harder?) for the child to participate in activities at home, school, or in a community setting with scores between 1 and 4; increased scores indicate environmental help.
Measured: change from baseline to end of the 1 week and 4 weeks
Pediatric Quality of Life Inventory
Pediatric Quality of Life Inventory is a health-related quality-of-life scale for children and adolescents aged 2 to 18. There are three areas in which you can score. The first is the scale total score, followed by the physical health total score, and finally the psychosocial health total score, which is calculated from the item scores assessing emotional, social, and school functions. The Pediatric Quality of Life Inventory is a 23-item quality of life scale that is appropriate for use in large groups such as schools and hospitals, as well as in both healthy and unhealthy children and adolescents. The items are graded on a scale of 0 to 100. The answer is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as occasionally, 25 if it is marked as frequently, and 0 if it is marked as almost constantly. The higher the total PedsQL score, the higher the perceived health-related quality of life.
Measured: change from baseline to end of the 1 week and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion16 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Model description
- Randomized Controlled Trial, Modified Delphi Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
- Investigators
- Ozgun Kaya Kara, Assoc. Prof., Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943587
- Sponsor's protocol ID
- 2022-127
- Status last verified
- Jul 2023
- First submitted
- 31 May 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tracey I, Mantyh PW. The cerebral signature for pain perception and its modulation. Neuron. 2007 Aug 2;55(3):377-91. doi: 10.1016/j.neuron.2007.07.012.
PubMed 17678852Pas R, Meeus M, Malfliet A, Baert I, Oosterwijck SV, Leysen L, Nijs J, Ickmans K. Development and feasibility testing of a Pain Neuroscience Education program for children with chronic pain: treatment protocol. Braz J Phys Ther. 2018 May-Jun;22(3):248-253. doi: 10.1016/j.bjpt.2018.02.004. Epub 2018 Mar 4.
PubMed 29550259Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
PubMed 27351541Malfliet A, Leysen L, Pas R, Kuppens K, Nijs J, Van Wilgen P, Huysmans E, Goudman L, Ickmans K. Modern pain neuroscience in clinical practice: applied to post-cancer, paediatric and sports-related pain. Braz J Phys Ther. 2017 Jul-Aug;21(4):225-232. doi: 10.1016/j.bjpt.2017.05.009. Epub 2017 May 19.
PubMed 28579013Nijs J, Torres-Cueco R, van Wilgen CP, Girbes EL, Struyf F, Roussel N, van Oosterwijck J, Daenen L, Kuppens K, Vanwerweeen L, Hermans L, Beckwee D, Voogt L, Clark J, Moloney N, Meeus M. Applying modern pain neuroscience in clinical practice: criteria for the classification of central sensitization pain. Pain Physician. 2014 Sep-Oct;17(5):447-57.
PubMed 25247901Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.
PubMed 26051220Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
PubMed 30831273Robins H, Perron V, Heathcote LC, Simons LE. Pain Neuroscience Education: State of the Art and Application in Pediatrics. Children (Basel). 2016 Dec 21;3(4):43. doi: 10.3390/children3040043.
PubMed 28009822Siddall B, Ram A, Jones MD, Booth J, Perriman D, Summers SJ. Short-term impact of combining pain neuroscience education with exercise for chronic musculoskeletal pain: a systematic review and meta-analysis. Pain. 2022 Jan 1;163(1):e20-e30. doi: 10.1097/j.pain.0000000000002308.
PubMed 33863860
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of Culturally Sensitive Pain Neuroscience Education in Children With Chronic Pain
- ClinicalTrials.gov ID
- NCT05943587
- Acronym / sponsor ID
- 2022-127
- Conditions
- Chronic Pain, Child, Only
- Keywords
- Chronic Pain, Children, Pain Neuroscience Education, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 16 May 2024 (estimated)
- First posted
- 13 Jul 2023 (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.
The International Association for the Study of Pain and The International Classification of Diseases (ICD) 11 define chronic pain as pain lasting more than 3 months, regardless of the cause. For children and adolescents, chronic pain is an extremely terrible and suffering problem. Periods of persistent pain negatively affect the child's participation in school and recreational activities, leading to academic problems and social exclusion. Moreover, children are at increased risk of experiencing chronic pain problems in adulthood. Because of these difficulties children with chronic pain should be treated as soon as possible. Pain Neuroscience Education (PNE) is an educational approach used in chronic pain rehabilitation. The purpose of PNE is to change individual's perception of pain. The most fundamental and crucial aspect of PNE is educating patients about the underlying causes of their pain. The primary purpose of the project is to conduct a modified Delphi survey to obtain and synthesize expert opinions on PNE materials. The second aim of this study is to investigate the effect of PNE on pain, quality of life and participation in children with chronic pain and compare it with the standard treatment program.
Detailed description
Chronic pain is not directly cause death but it is a major source of disability and suffering. Because of the enormous medical, economic, and social burden of chronic pain worldwide better understanding of pain biology has become a critical topic in order to develop targeted, novel, safe, and effective treatments. Pain Neuroscience Education (PNE) is a multidisciplinary educational method used by physiotherapists worldwide in chronic pain rehabilitation. The goal of PNE is to alter a person's perception of pain. PNE aims to correct patient misconceptions about pain physiology. As a result, pain education can help to reduce levels of fear of pain, fear of movement, pain catastrophizing thoughts, and passive coping strategies (for example, the use of painkillers or massage treatments). Currently, only a few research have investigated the benefits of PNE in children. The majority of studies have focused on pain management education programs rather than explaining the neurology of pain. The combined effects of PNE and physiotherapy have not been studied in children. But adult studies are demonstrated that PNE and physiotherapy are effective. According to studies, PNE has been linked to promising results in the treatment of chronic pain and functional impairment in adults. James et al. concluded that PNE reduced pain, disability, pain catastrophization, and kinesiophobia in the short and medium term, based on a systematic evaluation of 12 randomized controlled studies assessing the effect of PNE in individuals with chronic musculoskeletal pain. Currently, no study has been conducted in investigators country that has adapted PNE for children and evaluated the consequences of PNE use. The primary aim of the research is to perform a modified Delphi survey to obtain and synthesize expert opinions on culturally appropriate PNE materials for children in terms of content, relevance of information, clarity and intelligibility of information, and visual qualities of the materials. The second aim of the research is to investigate the impacts of culturally tailored PNE on pain symptoms (pain severity, pain awareness, fear of pain, catastrophizing pain, dealing with pain), quality of life, and involvement in children with chronic pain, as well as to compare it to a normal education program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial, Modified Delphi Study
| Arm | Type | Receives |
|---|---|---|
| Chronic pain group | Experimental | Other: culture-sensitive PNE4kids30-45 minute individual sessions of culture-sensitive PNE4kids training will be applied. |
| Control Group | Active comparator | Other: standard education30-45 minute individual sessions of standard education training will be applied. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 8 years and 12 years;
- Diagnosed with chronic pain (at least three months of pain and a pain frequency of three or more days per week)
- Those who do not take analgesics 48 hours prior to study evaluations.
Key exclusion criteria (2 listed)
- Patients with unmanageable psychological disorders (e.g., attention deficit hyperactivity disorder, autistic spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.
- Patients who started a new treatment during the trial or 6 weeks before to the study for chronic pain.
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 |
|---|---|---|
| culture-sensitive PNE4kidsCulturally adapted PNE4kids used by physiotherapists worldwide in chronic pain rehabilitation. | Other | Chronic pain group |
| standard educationStandard education used by physiotherapists worldwide in chronic pain rehabilitation. | Other | Control Group |
Primary outcome
Wong-Baker Faces Scale
Time frame: change from baseline to end of the 1 week and 4 weeks
It is a valid and reliable scale preferred by children and their families to evaluate the severity of pain. It consists of 6 facial expressions that symbolize the severity of pain. These show the stages of increased pain from a smiling face (0 points) to a very sad and crying face (10 points). The meaning of each facial expression is carefully explained to the child. Children rate pain intensity according to face shapes.It consists of 6 facial expressions that symbolize the severity of the pain. It is scored between 0-10. Increasing scores indicate more pain.
Pain Vigilance and Awareness Questionnaire Child & Adult Version
Time frame: change from baseline to end of the 1 week and 4 weeks
Pain Vigilance and Awareness Questionnaire Child evaluates children's attention to pain. There are 14 items on the scale. A 0-5 likert scale is used for scoring. It has a rating of 0 (never) to 5 (always) (always). The total score is calculated by multiplying the individual item scores. Pain Vigilance and Awareness Questionnaire-Adult uses 16 items to test adults' attention and pain awareness. It has ten items for paying attention and six ones for being aware. A 0-5 likert scale is used for scoring. 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always, and 5 = always. The scale's eighth and sixteenth items are scored in reverse order. The scaled total score ranges from 0 to 80. Higher ratings suggest that you are more conscious of your pain.Items are rated on a 6-point scale, ranging from 0 (never) to 5 (always). The 8th and 16th items of the scale are reverse scored. The scale total score is obtained between 0-80. Higher scores indicate greater awareness of pain.
Fear of Pain Questionnaire for Children/Parents
Time frame: change from baseline to end of the 1 week and 4 weeks
The Fear of Pain Questionnaire for Children-Short Form is a 10-item version of the 24-item Fear of Pain Questionnaire for Children. It uses children's self-reports to assess pain-related fears (4 items) and avoidance behaviours (6 items). A 0-4 Likert scale is used for scoring. A score of 0 indicates strong disagreement, while a score of 5 indicates strong agreement.Items are summed to derive a total score (with between 0-40) . Higher scores indicate higher pain-related fear and avoidance behaviors.
Pain Catastrophizing Scale- Child
Time frame: change from baseline to end of the 1 week and 4 weeks
Crombez et al. created the Pain Catastrophizing Scale-Child, an adaptation of the Pain Catastrophizing Scale for children. Catastrophizing behaviours is evaluated with 13 items: rumination (4 items), magnification (3 items), and helplessness (6 items). The scoring is done on a 0-4 point Likert scale. It is evaluated on a scale of 0 (not at all) to 4 (very extremely).Items are summed to derive a total score (with between 0-52), with higher scores indicating more pain catastrophizing.
Functional Disability Inventory
Time frame: change from baseline to end of the 1 week and 4 weeks
Walker and Greene developed the Functional Disability Inventory to assess challenges faced by school-age children and adolescents in executing activities of daily living from the child's perspective. There are 15 items in Functional Disability Inventory. Each item asks about how many physical challenges or obstacles the youngster has experienced while executing the activity in the previous few days. The scoring is done on a 0-4 point Likert scale. It is ranked between 0 (no problem) and 4 (impossible). Items are summed to derive a total score (with between 0-60) , with higher total scores indicating greater disability.
Pain Coping Questionnaire
Time frame: change from baseline to end of the 1 week and 4 weeks
Evaluates the coping strategies of children and adolescents with a total of 39 items in 8 subscales. These are seeking knowledge, problem solving, seeking social support, positive self-suggestion, behavioural distraction, cognitive distraction, externalization, and internalization/catastrophizing. Items are assessed on a 5-point Likert scale, with 1 indicating never and 5 indicating very often. Higher ratings indicate higher use of coping strategy. PCQ consists of parent and adolescent form.The scores for each subscale are calculated by averaging the items. Higher scores indicate that the child uses strategies to cope more frequently.
2 secondary outcomes
Participation and Environment- Children and Youth
Time frame: change from baseline to end of the 1 week and 4 weeks
Pediatric Quality of Life Inventory
Time frame: change from baseline to end of the 1 week and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 17678852Tracey I, Mantyh PW. The cerebral signature for pain perception and its modulation. Neuron. 2007 Aug 2;55(3):377-91. doi: 10.1016/j.neuron.2007.07.012.
- Background: PubMed 29550259Pas R, Meeus M, Malfliet A, Baert I, Oosterwijck SV, Leysen L, Nijs J, Ickmans K. Development and feasibility testing of a Pain Neuroscience Education program for children with chronic pain: treatment protocol. Braz J Phys Ther. 2018 May-Jun;22(3):248-253. doi: 10.1016/j.bjpt.2018.02.004. Epub 2018 Mar 4.
- Background: PubMed 27351541Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
- Background: PubMed 28579013Malfliet A, Leysen L, Pas R, Kuppens K, Nijs J, Van Wilgen P, Huysmans E, Goudman L, Ickmans K. Modern pain neuroscience in clinical practice: applied to post-cancer, paediatric and sports-related pain. Braz J Phys Ther. 2017 Jul-Aug;21(4):225-232. doi: 10.1016/j.bjpt.2017.05.009. Epub 2017 May 19.
- Background: PubMed 25247901Nijs J, Torres-Cueco R, van Wilgen CP, Girbes EL, Struyf F, Roussel N, van Oosterwijck J, Daenen L, Kuppens K, Vanwerweeen L, Hermans L, Beckwee D, Voogt L, Clark J, Moloney N, Meeus M. Applying modern pain neuroscience in clinical practice: criteria for the classification of central sensitization pain. Pain Physician. 2014 Sep-Oct;17(5):447-57.
- Background: PubMed 26051220Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.
- Background: PubMed 30831273Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
- Background: PubMed 28009822Robins H, Perron V, Heathcote LC, Simons LE. Pain Neuroscience Education: State of the Art and Application in Pediatrics. Children (Basel). 2016 Dec 21;3(4):43. doi: 10.3390/children3040043.
- Background: PubMed 33863860Siddall B, Ram A, Jones MD, Booth J, Perriman D, Summers SJ. Short-term impact of combining pain neuroscience education with exercise for chronic musculoskeletal pain: a systematic review and meta-analysis. Pain. 2022 Jan 1;163(1):e20-e30. doi: 10.1097/j.pain.0000000000002308.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Ozgun Kaya Kara, Assoc. Prof. study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing culture-sensitive PNE4kids and standard education in people with Chronic Pain and Child, Only, run by Akdeniz 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 3 inclusion and 2 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 13 Jul 2023. 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?
Contact ishak Isık, Prof. Dr. (02422494400, etik.kurul.07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Faces Scale (time frame: change from baseline to end of the 1 week and 4 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?
On the ClinicalTrials.gov record for NCT05943587, which also lists 9 linked publications.
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 13 Jul 2023.