The Effects of Chiropractic Care and Children With Subclinical Spinal Pain
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05369143 |
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Recruitment Status :
Completed
First Posted : May 11, 2022
Last Update Posted : August 21, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Subclinical Spinal Pain | Other: Chiropractic care Other: Control Group | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 107 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Effects of Chiropractic Care on Neurophysiological Function Immune Markers and Health Related Quality of Life in Children With Subclinical Spinal Pain Using Artificial Intelligence Modelling |
| Actual Study Start Date : | May 30, 2022 |
| Actual Primary Completion Date : | November 1, 2022 |
| Actual Study Completion Date : | December 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Chiropractic care Group
A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor with at least five years of clinical experience.The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. Chiropractors use these biomechanical characteristics as clinical indicators of spinal dysfunction and vertebral subluxation.
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Other: Chiropractic care
The mechanical properties of chiropractic adjustment have been investigated; and although the actual force applied to the patient's spine depends on the chiropractor, the patient, and the spinal location of the subluxation, the general shape of the force-time history of spinal adjustments is very consistent68 and the duration of the thrust is always less than 200 milliseconds. |
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Placebo Comparator: Control Group
The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The control intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust. No spinal adjustment will be performed during any control intervention. This control intervention is not intended to act as a sham treatment session
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Other: Control Group
The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust |
- Functional near-infrared spectroscopy (fNIRS) [ Time Frame: Base line ]Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks (Cognitive tasks). A baseline assessment of a participant will be done before the start of the intervention.
- Functional near-infrared spectroscopy (fNIRS) [ Time Frame: After 6 weeks of intervention ]Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks (Cognitive tasks). Assessment of participants will be repeated after 6 weeks of intervention.
- Functional near-infrared spectroscopy (fNIRS) [ Time Frame: After 12 weeks of intervention and 16 weeks (4-week follow-up testing in a sub-group of participants. ) ]Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks (Cognitive tasks). Assessment of participants will be repeated after 12 weeks of intervention.
- Functional near-infrared spectroscopy (fNIRS) [ Time Frame: After 16 weeks of intervention ]Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks (Cognitive tasks). Assessment of participants will be repeated after 16 weeks of intervention.
- Heart rate variability [ Time Frame: Up to 16 Weeks ]Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention.
- Whole head EEG(sub-cohort of participants) [ Time Frame: Base line ]
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.
A baseline assessment will be done before applying intervention.
- Whole head EEG(sub-cohort of participants) [ Time Frame: After 6 weeks of intervention ]The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention. Assessment of participants will be repeated after 6 weeks of intervention.
- Whole head EEG(sub-cohort of participants) [ Time Frame: After 12 weeks of intervention ]The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention. Assessment of participants will be repeated after 12 weeks of intervention.
- Whole head EEG(sub-cohort of participants) [ Time Frame: After 16 weeks of intervention ]The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention. Assessment of participants will be repeated after 16 weeks of intervention.
- Spatial working memory (SWM) [ Time Frame: Base line ]
Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory error.
Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy.
Fewer errors mean good spatial working memory and vice versa for more errors. A baseline assessment of a participant will be done before the start of the intervention.
- Spatial working memory (SWM) [ Time Frame: After 6 weeks of intervention ]
Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory error.
Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy.
Fewer errors mean good spatial working memory and vice versa for more errors. Assessment of participants will be repeated after 6 weeks of intervention.
- Spatial working memory (SWM) [ Time Frame: After 12 weeks of intervention ]
Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory error.
Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy.
Fewer errors mean good spatial working memory and vice versa for more errors. Assessment of participants will be repeated after 12 weeks of intervention.
- Spatial working memory (SWM) [ Time Frame: After 16 weeks of intervention ]
Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory error.
Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy.
Fewer errors mean good spatial working memory and vice versa for more errors. Assessment of participants will be repeated after 16 weeks of intervention.
- Reaction time (RTI) [ Time Frame: Base line ]
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time. A baseline assessment of a participant will be done before the start of the intervention.
- Reaction time (RTI) [ Time Frame: After 6 weeks of intervention ]
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time. Assessment of participants will be repeated after 6 weeks of intervention.
- Reaction time (RTI) [ Time Frame: After 12 weeks of intervention ]
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time. Assessment of participants will be repeated after 12 weeks of intervention.
- Reaction time (RTI) [ Time Frame: After 16 weeks of intervention ]
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time. Assessment of participants will be repeated after 16 weeks of intervention.
- Paired Associate Learning (PAL) [ Time Frame: Base line ]Paired Associates Learning assesses visual memory and new learning Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. A baseline assessment of a participant will be done before the start of the intervention.
- Paired Associate Learning (PAL) [ Time Frame: After 6 weeks of intervention ]Paired Associates Learning assesses visual memory and new learning Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Assessment of participants will be repeated after 6 weeks of intervention.
- Paired Associate Learning (PAL) [ Time Frame: After 12 weeks of intervention ]Paired Associates Learning assesses visual memory and new learning Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Assessment of participants will be repeated after 12 weeks of intervention.
- Paired Associate Learning (PAL) [ Time Frame: After 16 weeks of intervention ]Paired Associates Learning assesses visual memory and new learning Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Assessment of participants will be repeated after 16 weeks of intervention.
- Stockings of Cambridge (SoC) [ Time Frame: At Baseline ]Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. A baseline assessment of a participant will be done before the start of the intervention.
- Stockings of Cambridge (SoC) [ Time Frame: After 6 weeks of intervention ]
Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli.
Assessment of participants will be repeated after 6 weeks of intervention.
- Stockings of Cambridge (SoC) [ Time Frame: After 12 weeks of intervention ]Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. Assessment of participants will be repeated after 12 weeks of intervention.
- Stockings of Cambridge (SoC) [ Time Frame: After 16 weeks of intervention ]Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. Assessment of participants will be repeated after 16 weeks of intervention.
- Delayed Matching to Sample (DMS) [ Time Frame: At Baseline ]Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. A baseline assessment of a participant will be done before the start of the intervention.
- Delayed Matching to Sample (DMS) [ Time Frame: After 6 weeks of intervention ]Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Assessment of participants will be repeated after 6 weeks of intervention.
- Delayed Matching to Sample (DMS) [ Time Frame: After 12 weeks of intervention ]Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Assessment of participants will be repeated after 12 weeks of intervention.
- Delayed Matching to Sample (DMS) [ Time Frame: After 16 weeks of intervention ]Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Assessment of participants will be repeated after 16 weeks of intervention.
- Health-related quality of life [ Time Frame: Base line ]
The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. PROMIS Pediatric v2.0 profile 25 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. A baseline assessment of a participant will be done before the start of the intervention.
The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
- Health-related quality of life [ Time Frame: After 6 weeks of intervention ]
The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. PROMIS Pediatric v2.0 profile 25 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. Assessment of participants will be repeated after 6 weeks of intervention.
The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
- Health-related quality of life [ Time Frame: After 12 weeks of intervention ]
The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. PROMIS Pediatric v2.0 profile 25 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. Assessment of participants will be repeated after 12 weeks of intervention.
The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
- Health-related quality of life [ Time Frame: After 16 weeks of intervention ]
The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. PROMIS Pediatric v2.0 profile 25 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. Assessment of participants will be repeated after 16 weeks of intervention.
The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
- Saliva Cortisol [ Time Frame: Base line ]
Cortisol can alter cytokine levels (such as increasing IL-6 pro-inflammatory cytokines) that then alter the levels of inflammation throughout the body. Cortisol could be measured from saliva samples.
Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. A baseline assessment of a participant will be done before the start of the intervention.
- Saliva Cortisol [ Time Frame: after 12 weeks of intervention ]
Cortisol can alter cytokine levels (such as increasing IL-6 pro-inflammatory cytokines) that then alter the levels of inflammation throughout the body. Cortisol could be measured from saliva samples.
Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. Assessment of participants will be repeated after 12 weeks of intervention.
- Saliva Cortisol [ Time Frame: after 16 weeks of intervention ]
Cortisol can alter cytokine levels (such as increasing IL-6 pro-inflammatory cytokines) that then alter the levels of inflammation throughout the body. Cortisol could be measured from saliva samples.
Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. Assessment of participants will be repeated after 16 weeks of intervention.
- Hair Cortisol [ Time Frame: Baseline ]
Cortisol can alter cytokine levels (such as increasing IL-6 pro-inflammatory cytokines) that then alter the levels of inflammation throughout the body. Cortisol could be measured from Hair samples.
Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. Assessment of participants will be done at the baseline of the study.
- Hair Cortisol [ Time Frame: After 12 weeks of intervention ]
Cortisol can alter cytokine levels (such as increasing IL-6 pro-inflammatory cytokines) that then alter the levels of inflammation throughout the body. Cortisol could be measured from Hair samples.
Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. Assessment of participants will be repeated after 12 weeks of intervention.
- Immune Function Questionnaire (IFQ) [ Time Frame: At baseline ]
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. A baseline assessment of a participant will be done before the start of the intervention.
Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.
- Immune Function Questionnaire (IFQ) [ Time Frame: After 6 weeks of intervention ]The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.
- Immune Function Questionnaire (IFQ) [ Time Frame: After 12 weeks of intervention ]The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 12 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.
- Immune Function Questionnaire (IFQ) [ Time Frame: After 16 weeks of intervention ]The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 16 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.
- Inflammation markers from Fitbit data [ Time Frame: Up to 16 Weeks ]Fitbit can be used to measure the autonomic nervous system (ANS). Heart rate variability (HRV) has become a validated marker of autonomic function. In a large population-based study it was found that strong and independent relationships between HR and HRV with a broad set of inflammatory biomarkers. The recording will be done for up to 16 weeks.
- Smartphone Gait and Balance Application [ Time Frame: Baseline ]The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done at baseline.
- Smartphone Gait and Balance Application [ Time Frame: After 6 weeks of intervention ]The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done after 6 weeks.
- Smartphone Gait and Balance Application [ Time Frame: After 12 weeks of intervention ]The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done after 12 weeks.
- Smartphone Gait and Balance Application [ Time Frame: After 16 weeks of intervention ]The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done after 16 weeks.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- aged between 10 and 18 years
- have subclinical spinal pain
Exclusion Criteria:
- no evidence of spinal dysfunction is present
- they are in current pain (above 3/10 on VAS)
- have sought previous treatment for their spinal issues
- are unable to perform the assessment procedures due to contraindications or movement limitations
- diagnosed immune dysfunction
- utilizing a prescribed immunosuppressive medication
- have uncontrolled asthma
- nasal polyps
- use of an intranasal steroid spray one month or less before the study
- are HIV-positive
- are participating in another research study at the time of data collection
- have any diagnosed comorbidity or concomitant disease
- have allergies to yeast or yeast-derived products
- have chronic sinusitis or recent (within the last six weeks) episode of acute sinusitis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05369143
| Pakistan | |
| Mera Ghar Orphan House | |
| Rawalpindi, Pakistan | |
| Principal Investigator: | IMRAN KHAN NIAZI, PhD | New Zealand College of Chiropractic |
| Responsible Party: | Riphah International University |
| ClinicalTrials.gov Identifier: | NCT05369143 |
| Other Study ID Numbers: |
REC/01286 Imran Amjad |
| First Posted: | May 11, 2022 Key Record Dates |
| Last Update Posted: | August 21, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |