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Pain Neuroscience Education and Exercise in High School Students With Chronic Idiopathic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pain Neuroscience Education and Exercise
Exercise
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Chronic Neck Pain, Adolescents, Pain Neuroscience Education, Exercise

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Students with chronic and idiopathic NP for at least 3 months
  • Have a pain intensity of NPS greater than or equal to 2
  • Not receiving any treatment for NP (except analgesic)

Exclusion Criteria:

  • All students with nervous or rheumatic system pathology
  • Students attending special education (because they may need more accompaniment which, in this group intervention, will not be possible)

Sites / Locations

  • Adolfo Portela High School
  • Dr. Jaime Magalhães Lima High School
  • José Estevão High School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pain Neuroscience Education and Exercise

Exercise

Arm Description

Participants will received an 8-week intervention consisting of exercise and pain neuroscience education. Pain neuroscience education will be conducted in line with international guidelines and will address the following topics: pain neurophysiology, nociception and nociceptive pathways, inhibition and spinal cord stimulation, peripheral and central sensitization, nervous system plasticity and the impact of variables such as stress, anxiety, sleep and exercise on pain behavior. Exercise will be performed in accordance with international guidelines for chronic NP. Motor control, endurance and strengthening exercises will be performed for the neck and scapulo-thoracic region.

Participants will received an 8-week intervention consisting of exercise. The exercise performed in this group will be the same as in the intervention group and will follow the same international guidelines for chronic NP.

Outcomes

Primary Outcome Measures

Intensity of pain
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Intensity of pain
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Intensity of pain
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

Secondary Outcome Measures

Pain location
Assessed using a body chart where the patients identifies the painful body segments
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Pain frequency
Assessed using a closed question about pain frequency in the last week. (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Pain frequency
Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Pain frequency
Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Physical activity
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Physical activity
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Physical activity
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Disability
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Disability
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Disability
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Sleep
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Sleep
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Sleep
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Fear of movement
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Fear of movement
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Fear of movement
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Self-efficacy
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Self-efficacy
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Self-efficacy
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Central Sensitization
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Central Sensitization
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Central Sensitization
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Knowledge of pain neuroscience
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Knowledge of pain neuroscience
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Knowledge of pain neuroscience
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Muscular resistance of the deep flexor muscles of the cervical
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular resistance of the deep flexor muscles of the cervical
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular resistance of the deep flexor muscles of the cervical
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular endurance of the deep cervical extensor muscles
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular endurance of the deep cervical extensor muscles
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular endurance of the deep cervical extensor muscles
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular resistance of the stabilizing muscles of the scapular girdle
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular resistance of the stabilizing muscles of the scapular girdle
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Muscular resistance of the stabilizing muscles of the scapular girdle
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Pressure Pain Threshold
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Pressure Pain Threshold
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Pressure Pain Threshold
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)

Full Information

First Posted
October 1, 2019
Last Updated
February 22, 2021
Sponsor
Aveiro University
Collaborators
Foundation for Science and Technology, Portugal
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1. Study Identification

Unique Protocol Identification Number
NCT04125901
Brief Title
Pain Neuroscience Education and Exercise in High School Students With Chronic Idiopathic Neck Pain
Official Title
Chronic Idiopathic Neck Pain in High School Students: Effectiveness of an Intervention Based on Exercise and Pain Neuroscience Education
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
Collaborators
Foundation for Science and Technology, Portugal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Musculoskeletal pain can affect up to 40% of children and adolescents. Neck pain (NP) is one of the most prevalent painful conditions and evidence suggests that its prevalence has increased in recent decades in adolescents aged 16 to 18 years, from 22.9% in 1991 to 29.5% in 2011. Interventions based on pain neuroscience education have emerged as promising strategies in chronic pain conditions.In adults this intervention has been explored in many pain conditions, including musculoskeletal pain, but there is only one pilot study in adolescents with chronic NP and one case study in adolescents with fibromyalgia. Thus, the main objective of the present study is: (i) To compare the effectiveness of an education program based on pain neuroscience education and exercise versus exercise alone, in decreasing pain intensity in secondary school students with chronic and idiopathic NP immediately after the intervention and at 6 months. The secondary objectives are to: i) Compare the effectiveness of these programs immediately after the intervention and at 6 months in i) disability, ii) sleep, iii) pain catastrophizing, iv) fear of movement, v) self-efficacy, vi) central sensitization vii) the strength of the deep neck flexors and extensors muscles and stabilizers of the scapula; and viii) the pressure pain threshold between the two intervention groups; ii) Explore possible predictors of response to treatment.
Detailed Description
It is anticipated that the sample will consist of 127 participants from four secondary schools that will be divided into two groups. Both groups will receive the same exercise-based intervention. The experimental group will receive, in addition to exercise, an intervention based on pain neuroscience education. The intervention will consist of 1 session per week during 8 weeks and will be applied in small groups. The intervention will be performed in a blended-learning format. Five sessions will be face-to-face with up to 45 minutes duration, performed at school and incorporated into physical education classes and 3 will be performed at home, supported by vídeos sent by WhatsApp. The first two sessions will always be face-to-face. Face-to-face sessions will be interspersed with WhatsApp sessions. Participants will be assessed, by online questionnaires, for sociodemographic aspects, pain characterization and physical activity level, disability, sleep, catastrophizing, fear of movement, self-efficacy, central sensitization and knowledge on pain neurophysiology. In addition, 3 muscle tests will be performed for the deep neck flexor and extensor muscles and scapular stabilizers, and the pressure pain thresholds in the neck and at distance will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Chronic Neck Pain, Adolescents, Pain Neuroscience Education, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education and Exercise
Arm Type
Experimental
Arm Description
Participants will received an 8-week intervention consisting of exercise and pain neuroscience education. Pain neuroscience education will be conducted in line with international guidelines and will address the following topics: pain neurophysiology, nociception and nociceptive pathways, inhibition and spinal cord stimulation, peripheral and central sensitization, nervous system plasticity and the impact of variables such as stress, anxiety, sleep and exercise on pain behavior. Exercise will be performed in accordance with international guidelines for chronic NP. Motor control, endurance and strengthening exercises will be performed for the neck and scapulo-thoracic region.
Arm Title
Exercise
Arm Type
Other
Arm Description
Participants will received an 8-week intervention consisting of exercise. The exercise performed in this group will be the same as in the intervention group and will follow the same international guidelines for chronic NP.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education and Exercise
Intervention Description
The incorporation of the exercise in this group will be gradual, in order to decrease the education component and increase the exercise component (up to 45/60 minutes). The 1st session will be only PNE and will last approximately 45 minutes. In the 2nd session, there will be 30 minutes of PNE and the remaining 15 minutes of exercise. In the following 4th and 6th sessions, 15 minutes of each session will be used to clarify doubts and emphasize PNE concepts and strategies. The 8th session will include exercises only. In WhatsApp sessions, in addition to the video with the exercises, participants will receive activities about the PNE.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
The exercise group will perform exercises in all sessions (45 minutes of exercise in face-to-face sessions). In WhatsApp sessions, participants will receive a video with exercises to perform at home.
Primary Outcome Measure Information:
Title
Intensity of pain
Description
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Time Frame
Baseline
Title
Intensity of pain
Description
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Time Frame
8 weeks
Title
Intensity of pain
Description
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain location
Description
Assessed using a body chart where the patients identifies the painful body segments
Time Frame
Baseline
Title
Pain location
Description
Assessed using a body chart where the patients identifies the painful body segments
Time Frame
8 weeks
Title
Pain location
Description
Assessed using a body chart where the patients identifies the painful body segments
Time Frame
6 months
Title
Pain frequency
Description
Assessed using a closed question about pain frequency in the last week. (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Time Frame
Baseline
Title
Pain frequency
Description
Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Time Frame
8 weeks
Title
Pain frequency
Description
Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Time Frame
6 months
Title
Physical activity
Description
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Time Frame
Baseline
Title
Physical activity
Description
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Time Frame
8 weeks
Title
Physical activity
Description
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Time Frame
6 months
Title
Disability
Description
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Time Frame
Baseline
Title
Disability
Description
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Time Frame
8 weeks
Title
Disability
Description
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Time Frame
6 months
Title
Sleep
Description
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Time Frame
Baseline
Title
Sleep
Description
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Time Frame
8 weeks
Title
Sleep
Description
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Time Frame
6 months
Title
Pain catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
Baseline
Title
Pain catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
8 weeks
Title
Pain catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
6 months
Title
Fear of movement
Description
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
Baseline
Title
Fear of movement
Description
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
8 weeks
Title
Fear of movement
Description
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
6 months
Title
Self-efficacy
Description
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Time Frame
Baseline
Title
Self-efficacy
Description
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Time Frame
8 weeks
Title
Self-efficacy
Description
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Time Frame
6 months
Title
Central Sensitization
Description
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Time Frame
Baseline
Title
Central Sensitization
Description
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Time Frame
8 weeks
Title
Central Sensitization
Description
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Time Frame
6 months
Title
Knowledge of pain neuroscience
Description
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Time Frame
Baseline
Title
Knowledge of pain neuroscience
Description
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Time Frame
8 weeks
Title
Knowledge of pain neuroscience
Description
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Time Frame
6 months
Title
Muscular resistance of the deep flexor muscles of the cervical
Description
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
Baseline
Title
Muscular resistance of the deep flexor muscles of the cervical
Description
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
8 weeks
Title
Muscular resistance of the deep flexor muscles of the cervical
Description
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
6 months
Title
Muscular endurance of the deep cervical extensor muscles
Description
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
Baseline
Title
Muscular endurance of the deep cervical extensor muscles
Description
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
8 weeks
Title
Muscular endurance of the deep cervical extensor muscles
Description
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
6 months
Title
Muscular resistance of the stabilizing muscles of the scapular girdle
Description
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
Baseline
Title
Muscular resistance of the stabilizing muscles of the scapular girdle
Description
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
8 weeks
Title
Muscular resistance of the stabilizing muscles of the scapular girdle
Description
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Time Frame
6 months
Title
Pressure Pain Threshold
Description
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Time Frame
Baseline
Title
Pressure Pain Threshold
Description
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Time Frame
8 weeks
Title
Pressure Pain Threshold
Description
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Aged between 15 and 18 years
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Students with chronic and idiopathic NP for at least 3 months Have a pain intensity of NPS greater than or equal to 2 Not receiving any treatment for NP (except analgesic) Exclusion Criteria: All students with nervous or rheumatic system pathology Students attending special education (because they may need more accompaniment which, in this group intervention, will not be possible)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Andias, MD
Organizational Affiliation
University of Aveiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adolfo Portela High School
City
Aveiro
Country
Portugal
Facility Name
Dr. Jaime Magalhães Lima High School
City
Aveiro
Country
Portugal
Facility Name
José Estevão High School
City
Aveiro
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Neuroscience Education and Exercise in High School Students With Chronic Idiopathic Neck Pain

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